Clinical trial NCT03564145
Conditions: Papulopustular Rosacea
Sponsor: Sol-Gel Technologies, Ltd.
Start date: 2018-09-12; Completion date: 2019-11-13
Enrollment: 547 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).

Detailed description:
This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.

Arms: arm 1: Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks.
Interventions: intervention 1: S5G4T-1
Intervention descriptions: intervention 1: Once a day topical cream

Protocol documents:
Prot_002.pdf: 
CLINICAL STUDY PROTOCOL 
Title: 
A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to 
Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients 
Protocol No: 
SGT-54-07: November 27, 2018 
Protocol Version: 
4.0 
Original Version: 
3.0 
Sponsor: 
Sol-Gel Technologies Ltd. 
7 Golda Meir St. 
Weizmann Science Park 
Ness Ziona 7403650, Israel 
Confidential 
The information contained in this document is confidential and proprietary property of Sol-Gel Technologies, Inc. The recipient agrees that no 
unpublished information contained herein will be published or disclosed without prior written approval of Sol-Gel except as may be disclosed 
to independent ethics committees/institutional review boards or duly authorized representatives of the US Food and Drug Administration 
under the condition that they maintain confidentiality. 
NCT #NCT03564145


SGT-54-07, Ver 4.0 
 
 
2. 
PROTOCOL APPROVAL- SPONSOR SIGNATURE PAGE 
 
Protocol Title: 
 
Study Product: 
A Multi-Center, Open-Label, Long-Term Safety Studly of S5G4T-l to 
Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients 
S5G4T-1 
Sol-Gel Technologies Ltd. commits to conduct the study as described  hen in  in accordance with 
the current International Conference on Harmonization (ICH) - Good Clinical Practices (cGCPs) 
and the World Medical Association Declaration of Helsinki and in compliance with the obligations 
and requirements of the Sponsor as listed in 21 CFR Part 312. The following individuals approve 
the Nov 27, 2018 version of the SGT-54-07 protocol. All changes to this version of the protocol 
must have prior written approval and require an amendment or administrative letter. 
 
Sponsor Representative: 
 
 
Sol-Gel Technologies Ltd. 
7  Golda  Meir  St. 
Weizmann Science Park 
Ness Ziona 7403650, Israel 
Medical Monitor: 
 
 
Symbio, LLC 
21 Perry St. 
Port Jefferson, NY  11777 
 
Signature: 
Signature: 
 
Date: 
November 28, 2018 
Date: 
 
Biostatistics and Data Management: 
 
QST Consultations, Ltd. 
11275 Edgewater Dr. 
Allendale, Ml 49401 
Signature: 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
Page 2 of 69 


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3. 
INVESTIGATOR PROTOCOL ACKNOWLEDGMENT 
Protocol Title: A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to 
Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients 
Study Product:      S5G4T-1 
I have read this protocol and commit to conduct the study as outlined herein, in accordance with 
the current International Conference on Harmonization (ICH) current Good Clinical Practices 
(cGCPs) and the World Medical Association Declaration of Helsinki and complying with the 
obligations and requirements of clinical investigator(s) and all other requirements as listed in 
21 CFR Part 312 and all other applicable regulations. Any deviations will be agreed to by prior 
discussion between the Sponsor/Contract Research Organization (CRO) and me. 
I am thoroughly familiar with the appropriate use of the investigational products(s), as described 
in this protocol, and any other information provided by the sponsor or designee, including, but not 
limited to, the current Investigator Brochure (or equivalent document). I agree to provide sufficient 
time, and adequate numbers of qualified staff and facilities for the foreseen duration of the clinical 
study to conduct the study properly, ethically and safely. 
I agree to completely inform all patients in this study concerning the pertinent details and purpose 
of the study prior to their agreement to participate in the study in accordance with cGCPs and 
regulatory authority requirements. I will be responsible for maintaining each patient’s consent 
form in the study file and providing each patient with a copy of the signed consent form. 
 
 
 
Investigator’s Signature 
Date 
Investigator’s Printed Name 


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4. 
TABLE OF CONTENTS 
2. PROTOCOL APPROVAL – SPONSOR SIGNATURE PAGE ..............................................2 
3. INVESTIGATOR PROTOCOL ACKNOWLEDGMENT ......................................................3 
4. TABLE OF CONTENTS .........................................................................................................4 
5. PROTOCOL SYNOPSIS .........................................................................................................8 
5.1. 
Synopsis ........................................................................................................................8 
5.2. 
Study Flow Chart for patients entered from Study SGT-54-01 or SGT-54-02 ..........19 
5.3. 
Study Flow Chart for new patients only .....................................................................20 
6. LIST OF ABBREVIATIONS AND TERMS .........................................................................21 
7. INTRODUCTION AND BACKGROUND ...........................................................................22 
8. OBJECTIVE ...........................................................................................................................24 
9. ETHICS ..................................................................................................................................25 
10. INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED CONSENT .....................26 
11. OVERALL STUDY DESIGN ................................................................................................27 
12. STUDY POPULATION .........................................................................................................29 
12.1. Entry Criteria (only applies for patients entering from Phase 3, SGT-54-01 or 
SGT-54-02) .................................................................................................................29 
12.2. Patient Inclusion Criteria (applies only for new patients) ..........................................29 
12.3. Patient Exclusion Criteria (applies only for new patients): ........................................30 
12.4. Prohibited, Previous and Concomitant Therapies ......................................................32 
12.4.1. Patients entering from Phase 3, SGT-54-01 or SGT-54-02 ............................32 
12.4.2. New Patients ...................................................................................................33 
12.4.3. All Patients ......................................................................................................34 


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12.5. Precautions ..................................................................................................................35 
13. STUDY PROCEDURES ........................................................................................................37 
13.1. Study Patient Identification ........................................................................................37 
13.2. Screen Failure and Discontinuation Criteria...............................................................37 
13.3. Patient Screening and Enrollment...............................................................................38 
13.4. Method of Treatment Assignment ..............................................................................38 
13.5. Demographics/Medical History ..................................................................................38 
13.6. Concomitant Medications ...........................................................................................38 
13.7. Physical Examination .................................................................................................38 
13.8. Urine Pregnancy Test ..................................................................................................39 
13.9. Study Flow Chart for patients who entered from Study SGT-54-01 or 
SGT-54-02 ..................................................................................................................40 
13.10. Study Flow Chart for new patients only .....................................................................41 
.13.11 Screening Visit (Visit 1) for new patients only ..........................................................42 
13.12. Baseline Visit (Visit 2, Day 1) ....................................................................................42 
13.13. On-treatment (Visit 5, 8, 11; for new patients only: 14) – week 12, 24, 36; for 
new patients only: 48 - Day 85, 169, 253; for new patients: 337 (± 10 days) ............43 
13.14. On-treatment (Visit 3, 4, 6, 7, 9, 10; for new patients: 12, 13) – Week 4, 8, 
16, 20, 28, 32; for new patients: 36, 40, 44 - Day 29, 57, 113, 141, 197, 225; 
for new patients:  281, 309 (± 10 days) ......................................................................44 
13.15. Patients Who entering from Studies SGT-54-01 or SGT-54-02: End of 
Treatment (Visit 12) – Week 40, Day 281 (± 10 days) or Early Termination 
by the Patient or Sponsor. New Patients: End of Treatment (Visit 15) – 
Week 52, Day 365 (± 10 days) or Early Termination by the Patient or 
Sponsor .......................................................................................................................45 
14. CLINICAL OUTCOME ASSESSMENTS ............................................................................47 
14.1. Investigator Global Assessment (IGA) .......................................................................47 
14.2. Inflammatory Lesion Counts ......................................................................................47 
14.3. Erythema Severity Assessments .................................................................................47 
14.4. Telangiectasia Assessment .........................................................................................48 
14.5. Rosacea Quality of Life (RosaQoL) ...........................................................................48 
15. SAFETY EVALUATIONS ....................................................................................................50 
15.1. Cutaneous Safety Assessments ...................................................................................50 
15.2. Local Tolerability Assessments ..................................................................................50 
16. ADVERSE EVENTS ..............................................................................................................52 
16.1. Departure from the Protocol for Individual Patients ..................................................52 
16.2. Definitions ..................................................................................................................52 
16.3. Causal Relationship to Study product .........................................................................53 
16.4. Eliciting and Reporting of Adverse Events ................................................................53 
16.5. Expedited Reporting Responsibilities of the Study Center.........................................54 
16.6. Submitting an Expedited Safety Report to the IRB ....................................................54 
16.7. SAE & AEs Requiring Discontinuation of Study Drug, including Pregnancies ........55 
16.8. Pregnancy ...................................................................................................................55 
16.9. Post Study Adverse Events .........................................................................................56 
16.9.1. Non-serious Adverse Events ...........................................................................56 


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16.9.2. Serious Adverse Events ..................................................................................56 
17. STUDY PRODUCTS / CLINICAL SUPPLIES ....................................................................57 
17.1. Method of Treatment Assignment ..............................................................................57 
17.2. Formulation .................................................................................................................57 
17.3. Study Products Packaging and Labeling.....................................................................57 
17.4. Preparation, Dispensing and Storage Instructions ......................................................58 
17.5. Dosing Instructions .....................................................................................................58 
17.6. Study Product Accountability and Study Records at Sites .........................................59 
17.7. Return and Destruction of Study Product Supplies ....................................................59 
17.8. Additional Supplies Provided by Sponsor ..................................................................59 
18. STATISTICAL CONSIDERATIONS ...................................................................................60 
18.1. General Statistical Methodology ................................................................................60 
18.2. Populations Analyzed .................................................................................................60 
18.3. Analysis of Efficacy ...................................................................................................60 
18.4. Safety Evaluation ........................................................................................................61 
18.4.1. Exposure and Compliance ..............................................................................61 
18.4.2. Adverse Events ...............................................................................................61 
18.4.3. Vital Sign Measurements ................................................................................62 
19. ADMINISTRATIVE CONSIDERATIONS ..........................................................................63 
19.1. Protocol Compliance ..................................................................................................63 
19.2. Protocol Revisions ......................................................................................................63 
19.3. Protocol Monitoring ....................................................................................................63 
19.4. Required Study Documents ........................................................................................63 
19.5. Electronic Case Report Forms (eCRF)/Source Documents ........................................64 
19.6. Reports to the IRB/Ethics Committee (EC) ................................................................64 
19.7. Quality Assurance Audits ...........................................................................................64 
19.8. Records Retention .......................................................................................................64 
20. REFERENCES .......................................................................................................................65 


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LIST OF TABLES 
Table 1: 
Investigator Global Assessment (IGA) Scale ..................................................47 
Table 2: 
Rosacea Erythemaa Assessment Scale .............................................................48 
Table 3: 
Telangiectasia Assessment Scale .....................................................................48 
Table 4: 
Cutaneous Safety Assessment Scale ................................................................50 
Table 5: 
Local Tolerability Assessment Scale ..............................................................51 
 
LIST OF APPENDICES 
 
APPENDIX 1: 
PATIENT INSTRUCTION SHEET ................................................................66 
APPENDIX 2: 
ROSACEA QUALITY OF LIFE QUESTIONNAIRE (ROSAQOL) .............69 


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5. 
PROTOCOL SYNOPSIS 
 
5.1. 
Synopsis 
 
Title: 
A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to 
Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients 
Study Number: 
SGT-54-07 
Study Phase: 
3 
Indication: 
Papulopustular rosacea 
Study Period: 
In treatment period: up to 52 weeks (365 days) 
Study Products: 
S5G4T-1: Encapsulated Benzoyl Peroxide (E-BPO) Cream, 5%, 
developed by Sol-Gel Technologies and manufactured by 
, 
Montreal, Canada. 
Study Objectives: To assess the safety of S5G4T-1 when applied once daily for 
up to 52 weeks in patients with papulopustular rosacea. 
Study Design: 
Patients from the double-blind, Phase 3 studies SGT-54-01 and SGT-54-
02 may continue into this open-label, long-term safety study. Patients 
will be admitted into the study only after a written informed consent has 
been obtained and after completing Visit 6 within the Week 12 
window and not missing more than 1 visit of Visits 3, 4 or 5 in these 
studies. Eligible patients for enrollment may apply the study product, 
S5G4T-1, daily for up to 40 weeks to complete long-term usage of the 
drug for up to 52 weeks. 
The sponsor may also recruit patients for the long-term safety study only 
(and not as an extension study for phase 3) for a total of 52 weeks. In this 
case, the subject must meet the same inclusion and exclusion criteria as 
the phase 3 SGT-54-01 or SGT-54-02 studies, see section 12.2 and 12.3. 
The study will enroll patients who completed the SGT-54-01 and SGT- 
54-02 studies first. Study sites should not enroll new patients into SGT- 
54-07 until the Sponsor provides approval to do so. 
The Sponsor may terminate the recruitment after 300 patients complete a 
total of 28 weeks and 100 patients complete a total of 52 weeks of 
treatment. 
Study 
Population: 
Approximately 700 male and female patients who meet the study Entry 
Criteria (applies for patients who completed Study SGT-54-01 or SGT-
54-02) or who meet the Inclusion/Exclusion criteria (applies for new 
patients) will be enrolled with the intent that at least 300 patients will be 
followed for 28 weeks and at least 100 patients will be followed for 52 weeks. 
Drop-out patients will not be replaced. 
Investigational 
Sites 
It is estimated that up to 56 study centers in US will participate in this 
study. 


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Dosing: 
Patients will apply the study product if applicable once daily for up to52 
weeks. Patients will use a “pea-size” amount for each area of the face 
(chin, left cheek, right cheek, nose, left forehead and right forehead). The 
Study product will be spread as a thin layer in such a way as to provide an 
even distribution, avoiding the eyes, lips, inside the nose, mouth and all 
mucous membranes. Patients will receive detailed instructions on the 
method of application and quantity to use in order to assure that treatment 
is harmonized among all patients to best extent possible. 


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Methodology: 
Clinical and Safety Evaluations will be performed at: 
1. Visit 1/Screening, only applies for new patients 
2. Visit 2/Baseline, Day 1 can also be Visit 6/Week 12, Day 85 of 
Study SGT-54-01 or Study SGT-54-02 
3. Visit 3/Week 4, Day 29 (± 10 Days) 
4. Visit 4/Week 8, Day 57 (± 10 Days) 
5. Visit 5/Week 12, Day 85 (± 10 Days) 
6. Visit 6/Week 16, Day 113 (± 10 Days) 
7. Visit 7/Week 20, Day 141 (± 10 Days) 
8. Visit 8/Week 24, Day 169 (± 10 Days) 
9. Visit 9/Week 28, Day 197 (± 10 Days) 
10. Visit 10/Week 32, Day 225 (± 10 Days) 
11. Visit 11/Week 36, Day 253 (± 10 Days 
12. Visit 12/Week 40, Day 281 (± 10 Days)/ End of Treatment/End 
of Study for patients who complete the study, early terminate, or 
if the Sponsor terminates the study prematurely (only for patients 
that completed Study SGT-54-01 or Study SGT-54-02) 
Applies for new patients: 
13. Visit 13/Week 44, Day 309 (± 10 Days) 
14. Visit 14/Week 48, Day 337 (± 10 Days) 
15. Visit 15/Week 52, Day 365 (+ 10 Days)/ End of Treatment/End 
of Study for patients who complete the study, early terminate, or 
if the Sponsor terminates the study prematurely. 
Patients will be admitted into the study only if they completed 
Study SGT-54-01 or Study SGT-54-02 at Week 12 within the window 
time or missed no more than one study Visit 3, 4 or 5 in these studies. For 
patients that were enrolled for study SGT-54-01 or study SGT-54-02 
clinical exclusion criteria (IGA grade or lesion count) will not limit the 
enrollment for the study. New patients who meet specified inclusion 
criteria (including moderate to severe rosacea according to 5-point IGA 
scale and have a minimum total of 15 and a maximum total of 70 
inflammatory lesions (papules and/or pustules) including those present on 
the nose) and none of the exclusion criteria will be admitted to the study. 
At each visit a 5-point IGA scale of rosacea; rosacea erythema, and 
telangiectasia; will be performed and recorded. If a patient is assessed as 
“mild”, “moderate” or “severe” (2, 3 or 4 respectively), study product will 
be dispensed and the patient will use the study product daily according to 
patient instructions. If a patient is assessed as “clear” (0) or “almost clear” 
(1), the patient will not be dispensed the study product. 
In addition, at each visit, the following safety measures will be recorded: 
monitoring for any AE including local and systemic; investigator 
Cutaneous Safety Assessment rating of erythema, dryness and scaling and 


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Local Tolerability Assessments rating of itching and burning/stinging on 
a scale ranging from 0 (None) to 3 (Severe). 
Rosacea Quality of Life Questionnaire (RosaQoL) will be completed at 
Baseline, Visits 5, 8, 11, 14 and at End of Study or at early termination. 
The RosaQoL data of patients who were enrolled from SGT-54-01 or 
SGT-54-02, will be used from the questionnaire completed at Visit 
6/Week 12 of SGT-54-01 or SGT-54-02. Urine pregnancy tests will be 
performed on females of child-bearing potential at Screening (for new 
patient) and Baseline, and every 4 weeks during study or at early 
termination. 
Regardless of the duration of the study, patients that exhibit serious 
adverse event (SAE), will be followed up until the SAE stabilizes or 
resolves, based on investigator’s medical judgment. 


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Clinical Trial 
Duration 
Up to 52 weeks/365 days. 
The Sponsor may terminate the study once 100 patients complete a total 
of 52 weeks and 300 patients complete a total of 28 weeks of treatment 
(totals include 12 weeks from the double-blind treatment period of 
Study SGT-54-01 or Study SGT-54-02 for those previously enrolled in 
this studies). 
Patients have the right to stop the study for any reason at any given time. 
Study product 
dosage and 
Reference 
therapy 
Encapsulated Benzoyl Peroxide Cream, 5% will be dispensed every 
4 weeks. 
The study product will be supplied in 55-gram pumps (total weight 
including pump is 85 grams). 
Entry Criteria 
(applies for 
patients entering 
from Phase 3, 
SGT-54-01 or 
SGT-54-02) 
Patients rolling over from either Study SGT-54-01 or Study SGT-54-02 
may participate in the study if they meet the criteria below: 
1. Patient must sign an Institutional Review Board (IRB) approved 
written informed consent for the extension study. 
2. Complete 12 weeks or within the Week 12 window time (± 4 days) 
of the double-blind treatment period of Study SGT-54-01 or 
Study SGT-54-02 and missed not more than one visit of Visits 3, 4 
or 5 in Study SGT-54-01 or Study SGT-54-02. 
3. Patients who in the opinion of the investigator, are likely to be able 
to follow the restrictions of the protocol and complete the study. 
Patient Inclusion 
Criteria (applies 
for new patients 
only) 
New patients who were not previously enrolled in Study SGT-54-01 or 
Study SGT-54-02 must meet all the following criteria: 
1. Patient must sign an Institutional Review Board (IRB) approved 
written informed consent for this study. 
2. Male and female 18 years of age and older. 
3. Patients must have clinical diagnosis of moderate to severe rosacea 
with a Baseline Investigator’s Global Assessment (IGA) Score of 3 
(moderate severity) or 4 (severe) on a severity scale of 0 to 4. 
4. Have a minimum total of 15 and a maximum total of 70 inflammatory 
lesions (papules and/or pustules) including those present on the nose. 
5. Have two nodules or less (nodule defined as a papule or pustule 
greater than 5 mm in diameter) at Baseline. 
6. Patients must be willing and able to understand and comply with the 
requirements of the study, apply the medication as instructed, refrain 
from use of the following medications (during the study, return for 
the required treatment period visits, comply with therapy 
prohibitions, and are able to complete the study): 
− topical rosacea medication including: Metronidazole 0.75% to 
1%, Azelaic acid, Brimonidine, Oxymetazoline, Sodium 
Sulfacetamide 10%, Sulfur 5%, Benzoyl Peroxide, Clindamycin, 


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Erythromycin, Benzoyl Peroxide and Clindamycin, Sulfur lotions, 
retinoids, Ivermectin Cream 1%, Ivermectin lotion 0.5%; or 
− topical and systemic (oral and injectable) antibiotics known to 
impact rosacea e.g., tetracycline and its derivatives, erythromycin 
and its derivatives, doxycycline and its derivatives, minocycline 
and 
its 
derivatives, 
azithromycin 
and 
its 
derivatives, 
clarithromycin and its derivatives, metronidazole and its 
derivatives, sulfamethoxazole, or trimethoprim and retinoids (e.g., 
isotretinoin). 
7. Patients must be willing to minimize or not significantly alter 
controllable external factors that might trigger rosacea flare-ups 
(such as spicy food, thermally hot foods, soups and drinks, hot 
environments, prolonged sun exposure, strong winds, alcoholic 
beverages, etc.) throughout their participation in the study. 
8. Patients must be generally healthy and free from any clinically 
significant disease, other than rosacea, that might interfere with the 
study evaluations. 
9. Sexually active females of child-bearing potential, excluding women 
who are sterilized (including Essure procedure, tubal ligation, 
bilateral oophorectomy or hysterectomy) or post- menopausal for at 
least 2 years, must use one of the following birth control options*: 
• Intrauterine device (IUD) 
• Hormonal (injections, implants, transdermal patch, vaginal ring) 
• Abstinence 
• Oral contraceptives 
• Female condom 
• Diaphragm with spermicides 
• Cervical cap with spermicides 
• Contraceptive sponge 
* In addition, patients entering the trial that are on hormonal 
contraceptives must have been on this method for at least 3 months 
(90 days) prior to the trial and continue the method for the duration of 
the trial. Patients who had used hormonal contraception and stopped 
must have stopped no less than 3 months prior to Baseline. Patients 
entering the study who had an Essure procedure must have had this 
procedure at least 3 months prior to the study and have undergone an 
Essure confirmation test to ensure its efficacy. A sterile sexual partner 
is not considered an adequate form of birth control. 
Patient Exclusion 
Criteria (applies 
for new patients 
only): 
Patients who were not previously enrolled in Study SGT-54-01 or 
Study SGT-54-02 must be excluded from entry into the study according to 
the following criteria: 


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1. Females, who are pregnant, breastfeeding, or planning a pregnancy 
within the period of their study participation or were found to have 
positive pregnancy test at baseline or screening visits. 
2. Presence of more than 2 facial nodules or any nodule greater than 1 
cm. 
3. Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or 
keratitis) of sufficient severity to require topical or systemic 
antibiotics. 
4. Presence of any other facial skin condition that might interfere with 
rosacea diagnosis and/or assessment including but not limited to 
(e.g., on the face: rosacea conglobata, rosacea fulminans, acne 
vulgaris, acne conglobata, acne fulminans, or secondary acne 
(chloracne, drug-induced acne, etc.), facial pustulosis of the chin, 
dermatitis (including peri-orbital and seborrheic dermatitis), 
demodicidosis, facial keratosis pilaris, acute lupus erythematosus, 
psoriasis, eczema, acneiform eruptions caused by medications, 
steroid acne, steroid folliculitis, sunburn, rhinophyma, or bacterial 
folliculitis). 
5. Any uncontrolled, chronic or serious disease or medical condition 
that would prevent participation in a clinical trial or, in judgment of 
the Investigator, would put the patient at undue risk or might 
confound the study assessments. 
6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that 
would interfere with diagnosis or assessment of rosacea. 
7. History of unresponsiveness to topical benzoyl peroxide. 
8. Concurrent use of drugs causing acneiform eruptions (e.g., 
azathioprine, 
haloperidol, 
halogens, 
lithium, 
systemic 
corticosteroids, phenytoin, phenobarbital, testosterone, anabolic 
steroids, isoniazid). 
9. Known sensitivities to the study product ingredients. Allergy to 
benzoyl peroxide, parabens and glycerin or other ingredients listed 
in the investigator brochure. 
10. Use: 
− within 180 days prior to Baseline or during the study of oral 
retinoids (e.g., Accutane®) or therapeutic vitamin A supplements 
of greater than 10,000 units/day (multivitamins are allowed). 
− within 90 days prior to Baseline or during the study radiation 
therapy and/or anti-neoplastic agents. 
− start or change of dose within 90 days prior to Baseline or during 
the study of vasodilators, vasoconstrictors, anticoagulation or 
beta-blockers therapy and use throughout the study. Use of such 
therapy must remain constant throughout the study. 
− start or change of dose within 90 days prior to Baseline of 
hormonal treatment (oral, implanted, topical contraceptives and 


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androgens). Use of such therapy must remain constant during the 
study. 
− within 30 days prior to Baseline or during the study of therapeutic 
Vitamin D supplements of greater than 2,000 units/day (daily 
multivitamins with Vitamin D not exceeding more than 2000 
IU/day are allowed). If a patient on a constant stable prescribed 
weekly dose, they should remain on this dose during the study. 
− within 30 days prior to Baseline or during the study of (1) 
systemic steroids, (2) topical retinoids to the face (e.g., tretinoin) 
(3) systemic (e.g., oral or injectable) antibiotics known to impact 
rosacea (e.g., tetracycline and its derivatives, erythromycin and 
its derivatives, doxycycline and its derivatives, minocycline and 
its derivatives, macrolides and its derivatives, azithromycin and 
its derivatives, clarithromycin and its derivatives, metronidazole 
and its derivatives, sulfamethoxazole, bactrim or trimethoprim); 
short term treatment of all other antibiotics (not affecting rosacea 
for) ≤ 14 days for non-rosacea related conditions is acceptable, 
(4) immunosuppressive agents, or immunomodulators (e.g. 
cyclosporine, tacrolimus, pimecrolimus). 
− of 
medicated 
make-up 
(including 
anti-aging 
make-up) 
throughout the study and significant change in the use of 
consumer products within 14 days of study entry and throughout 
the study. 
− of niacin and niacinamide (Vitamin B3) within 24 hours of study 
entry and throughout the study. 
− of intranasal and inhaled corticosteroids do not require a washout 
and may be used throughout the study if at a stable and standard 
dose. 
11. Facial use within 14 days prior to Baseline or during the study of (1) 
topical steroids, (2) topical anti-inflammatory agents or topical non-
steroidal 
anti-inflammatory 
drugs 
(NSAID), 
(3) 
topical 
antimycotics, (4) any topical rosacea treatments (e.g., Metronizadole 
0.75% to 1%, Azelaic acid, Brimonidine, Oxymetazoline, Sodium 
Sulfacetamide 10%, Sulfur 5%, Benzoyl Peroxide, Clindamycin, 
Erythromycin, Benzoyl Peroxide and Clindamycin, Sulfur lotions, 
Retinoids, Ivermectin) or (5) topical antibiotics. 
12. Use on the face within 30 days prior to Baseline or during the study 
of (1) cryodestruction or chemodestruction, (2) dermabrasion, (3) 
photodynamic therapy, (4) acne surgery, (5) intralesional steroids, 
(6) laser resurfacing or electrodessication, (7) x-ray therapy, (8) pulse 
dye laser, (9) long-pulsed Nd-YAG laser, (10) Intense pulse light or 
pulse light laser, (11) electrocautery or electrocoagulation, (12) CO2 
laser, Fractioned lasers, or loop electrosurgery, (13) facial peels or 
other facial cosmetic surgery (e.g., Thermage®, etc.). 


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13. Use of medicated cleansers on the face (e.g., benzoyl peroxide, 
salicylic acid, sulfur or triclosan) within 7 days of Baseline and 
throughout the study. 
14. Patient consumes excessive alcohol, abuses drugs, or has a condition 
that could compromise the patient’s ability to comply with study 
requirements and/or have drug or alcohol addiction requiring 
treatment in the past 12 months. 
15. Use of topical astringents or abrasives (e.g., rubs, exfoliating 
cleansers and products containing salicylic acid and/or alcohol), 
topical preparations that contain spices or lime, medicated topical 
preparations (prescription and OTC products) within 7 days prior to 
Visit 2 (Baseline) and throughout the study. 
16. Use of antipruritics (including antihistamines), spa or sauna 
treatments or chlorine exposure (swimming pool etc.) within 24 
hours (1 day) of all study visits (Visit 2, Baseline, through End of 
Study). 
17. Participation in any clinical study involving an investigational 
product, agent or device that might influence the intended effects or 
mask the side effects of study product, within 30 days prior to Visit 
2 (Baseline) and throughout the study. 
18. Previous enrollment in this study or current enrollment in this study 
at another participating site. 
19. Employee (or employee’s family member) of the research center or 
private practice, or patients who have a conflict of interest. 
20. Patients living (e.g., siblings, spouses, relatives) in the same 
household cannot be enrolled in the study at the same time. 
21. Use of tanning booths, sun lamps or excessive UV radiation (e.g., 
phototherapy, daily extended exposure or occupational exposure to 
the sun), sunbathing or excessive exposure to the sun 1 week (7 days) 
prior to Baseline and throughout the study. 
22. Patients who in the opinion of the investigator, are unlikely to be able 
to follow the restrictions of the protocol and complete the study. 
Safety Endpoints: • Adverse events (AEs), including serious adverse events (SAEs) 
occurring at any time during the trial. 
• Investigator Cutaneous Safety Assessment and Local Tolerability 
Assessments score at any time during the trial. 
Safety: 
The incidence of all adverse events reported during the study will be 
summarized. Safety will be evaluated by comparing the nature, severity 
and frequency of their adverse event profiles. Safety variables include 
Investigator Cutaneous Safety Assessment score, treatment-emergent 
adverse events (AEs), SAEs, treatment related AEs, AEs leading to study 
discontinuation and concomitant medications 


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Statistical 
Method: 
General Statistical Methodology 
All statistical processing will be performed using SAS® version 9.3 or 
later unless otherwise stated. Data will be summarized using descriptive 
statistics. No inferential testing or imputations for missing data will be 
performed. No interim analyses are planned for the co-primary variables. 
For categorical parameters, the number and percentage of patients in each 
category will be presented. For continuous parameters, descriptive 
statistics will include n (number of patients), mean, standard deviation, 
median, minimum and maximum. 
Populations Analyzed 
All analyses will be performed using the Safety Population of the study. 
Part of this population will be referred as the extension safety population, 
and part as a new enrolled safety population. All patients who receive at 
least one confirmed dose of S5G4T-1 (in either Study SGT-54-01 or 
Study SGT-54-02, and in this study or for new patients in this study) and 
have at least one assessment will be included in the Safety Population. 
The number of patients included in the Safety Population will be 
summarized. 
Analysis of Efficacy 
This study is not intended to assess efficacy, but rather the IGA is included 
to determine the need for treatment and subsequent re-treatment. after the 
initial 12-week treatment course (in either Study SGT-54-01   or 
Study SGT-54-02 or for those patients not previously enrolled in 
Study SGT-54-01 or Study SGT-54-02) and any subsequent 4-week 
courses, if applicable. Certain efficacy data and endpoints will, however, 
be summarized. 
Descriptive statistics will be used to summarize the assessment of 
efficacy.   IGA scores will be summarized at Baseline   Visit of 
Study SGT-54-01 or Study SGT-54-02 or at the Screening visit of SGT- 
54-07 for those patients not previously enrolled in Study SGT-54-01 or 
Study SGT-54-02, and entry into the study (SGT-54-07) and every 
4 weeks through end of the study. The number and percentage of patients 
who achieve treatment success at the scheduled study visits will be 
tabulated. A patient will be considered a success if their IGA score is clear 
or almost clear. 
Rosacea Quality of Life Questionnaire (RosaQoL) will be completed at 
Baseline, Visits 5, 8, 11, 14 and End of Study visits. The RosaQoL data 
of patients who were enrolled from SGT-54-01 or SGT-54-02, will be 
used from the questionnaire completed at Visit 6/Week 12 of SGT-54-01 
or SGT-54-02. 


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Safety 
Evaluation: 
Safety will be evaluated by tabulations of adverse events (AEs), 
Cutaneous Safety Assessments (dryness and scaling), Local Tolerability 
Assessment (itching and burning) and assessments for erythema and 
telangiectasia will be presented with descriptive statistics at Baseline and 
at the scheduled study visits. Frequencies and percentages for each 
outcome category will be included in these statistics. Safety data will be 
presented for patients in the Safety Population with tabulations for the 
following periods 12 to 28 weeks, > 28 to 52 weeks and > 52 weeks to the 
end of the study, as well as an overall for all periods. 


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5.2. 
Study Flow Chart for patients entered from Study SGT-54-01 or SGT-54-02 
 
Procedure 
Visit 21,2,7 
Visit 3, 4, 6, 7, 9, 10 
Visit 5, 8, 11 
Visit 12 
(EOT3/ 
EOS4) 
Unscheduled 
Visit11 
Name of Visit 
Baseline 
Day 1 
Week 4, 8, 16, 20, 28, 325 
Day 29, 57, 113, 141, 197, 225 
Week 12, 24, 365 
Day 85, 169, 253 
Week 40 
Day 2816 
Visit window 
± 10 days 
± 10 days 
± 10 days 
Entry Criteria 
X 
Sign Informed 
Consent 
X 
Demographics 
X 
Medical 
History/Previous 
Therapies 
X 
Con med 
X 
X 
X 
X 
X 
Pregnancy Test7 
X 
X 
X 
X 
X 
Brief Physical 
Examination 
X 
X 
X 
X 
Cutaneous Safety 
Assessment and Local 
Tolerability 
Assessments 
X 
X 
X 
X 
X 
Administer/ Review 
Patient Instructions 
X 
X 
X 
X 
IGA8 
X 
X 
X 
X 
X 
Rosacea Erythema 
Assessment 
X 
X 
X 
X 
X 
Telangiectasia 
Assessment 
X 
X 
X 
X 
X 
Weigh Study Product 
X 
X 
X 
X 
X 
Study Product 
Dispensed9 
X 
X 
X 
X 
Provide Cleanser and 
Moisturizer/Sunscree 
n, if needed 
X 
X 
X 
X 
Study Product 
Collected 
X 
X 
X 
Diary Card dispensed 
X 
X 
X 
X 
Diary Card collected 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Complete RosaQoL10 
X 
X 
X 
 
 
1 Patient will be eligible for the extension study only after completing 12 weeks of one of the two Phase 3 studies SGT-54-01 or SGT-54-02 at 
the Week 12 window time (± 4 days) and missed not more than one visit of Visits 3, 4 or 5 in these studies. 
2 Same Visit as Visit 6 in Phase 3 Study SGT-54-01 or Study SGT-54-02. All procedures that were performed in Visit 6 of Study SGT-54-01 or 
Study SGT-54-02 will be captured in the Study SGT-54-07 source document. 
3 EOT – end of treatment. 
4 EOS – end of study. 
5      All visits must be in reference to baseline and counted accordingly. 
6      All Week 40 procedures should be completed for Patients who terminate early. 
7      Urine test for women of childbearing potential. 
8 For product dispensing eligibility 
9 The dispensation and usage of the pump is based on IGA score. 
10 RosaQoL is a Rosacea Quality of Life questionnaire 
11 Perform procedures per PI discretion. 


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5.3. 
Study Flow Chart for new patients only 
 
Procedure 
Visit 11 
Visit 2 
Visit 3, 4, 6, 7, 9, 10, 
12, 13 
Visit 5, 8, 11, 
14 
Visit 15 
(EOT2/ 
EOS3) 
Unscheduled 
Visit9 
Name of Visit 
Screening 
-35 to 0 
Baseline 
Day 1 
Week 4, 8, 16, 20, 28, 
32, 40, 44 Day 29, 57, 
113, 141, 197, 225, 281, 
309 
Week 12, 24, 
36, 48 
Day 85, 169, 
253, 336 
Week 52 
Day 3654 
Visit window 
± 10 days 
± 10 days 
± 10 days 
Inclusion/Exclusion 
Criteria 
X 
X 
Demographics 
X 
Medical 
History/Previous 
Therapies 
X 
X 
Sign Informed Consent 
X 
Brief Physical 
Examination 
X 
X 
X 
X 
Concomitant Therapy 
and Medication History 
Reviewed 
X 
X 
X 
X 
X 
X 
Pregnancy Test5 
X 
X 
X 
X 
X 
X 
Cutaneous Safety 
Assessment and Local 
Tolerability 
Assessments 
X 
X 
X 
X 
X 
Administer/ Review 
Patient Instructions 
X 
X 
X 
X 
IGA6 
X 
X 
X 
X 
X 
X 
Inflammatory Lesion 
Count 
X 
X 
Rosacea Erythema 
Assessment 
X 
X 
X 
X 
X 
Telangiectasia 
Assessment 
X 
X 
X 
X 
X 
Weigh Study Product 
X 
X 
X 
X 
X 
Study Product 
Dispensed7 
X 
X 
X 
X 
Provide Cleanser and 
Moisturizer/ 
Sunscreen, if needed 
X 
X 
X 
X 
Study Product Collected 
X 
X 
X 
Diary Card dispensed 
X 
X 
X 
X 
Diary Card collected 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
Complete RosaQoL8 
X 
X 
X 
 
 
 
 
1 Patient will be eligible for the study only after meeting all Inclusion/Exclusion criteria. 
2 EOT – end of treatment. 
3 EOS – end of study. 
4      All Week 52 procedures should be completed for Patients who terminate early. 
5      Urine test for women of childbearing potential. 
6 For product dispensing eligibility 
7 The dispensation and usage of the pump is based on IGA score. 
8 RosaQoL is a Rosacea Quality of Life questionnaire 
9 Perform procedures per PI discretion. 


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6. 
LIST OF ABBREVIATIONS AND TERMS 
 
AE(s) 
Adverse Event(s) 
BPO 
Benzoyl Peroxide 
°C 
Degrees Centigrade 
CFR 
Code of Federal Regulations 
CRO 
Contract Research Organization 
E-BPO 
Encapsulated Benzoyl Peroxide 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
G 
Grams 
cGCP 
current Good Clinical Practice 
H 
hour(s) 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IGA 
Investigator’s Global Assessment 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IWRS 
Interactive Web Response System 
MCMC 
Markov Chain Monte Carlo 
MedDRA 
Medical Dictionary for Regulatory Activities 
min 
Minutes 
mg 
Milligram 
OTC 
Over-the-Counter 
PP 
Per Protocol 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 


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7. 
INTRODUCTION AND BACKGROUND 
S5G4T-1 is an innovative topical formulation containing 5% encapsulated benzoyl peroxide (E-
BPO) that Sol-Gel is developing for the treatment of rosacea. If approved, S5G4T-1 will be the 
first product containing E-BPO for the treatment of rosacea. Sol-Gel believes S5G4T-1 has the 
potential to be as tolerable as, and more effective than, currently marketed rosacea drugs. 
Rosacea is a chronic and recurrent inflammatory dermatological disorder of unknown etiology. 
The disease is common, especially in fair-skinned people of Celtic and northern European heritage. 
The onset of the disorder is usually between the ages of 30 and 50. Early stages of the disease 
affect women more often than men at a ratio of 3 to 1 (Jansen and Plewig 1997 and 
McDonnell and Tomecki 2000). Rosacea usually starts as flushing and subtle redness on the 
cheeks, nose, chin or forehead. Alcohol, hot drinks, spicy foods, stress, sunlight and extreme heat 
or cold can trigger the onset of this disease. If left untreated, rosacea can slowly worsen over time. 
As the condition progresses, patients experience inflammatory lesions (papules and pustules), 
vivid erythema and telangiectasia. Patients may develop furuncles, cystic nodules, granulomas 
and tissue hypertrophy, sometimes leading to rhinophyma. 
The first report on the treatment of rosacea with benzoyl peroxide as a single agent was described 
by in Montes et al. in 1983. In this limited study, 5% benzoyl peroxide, after 5 to 8 weeks of 
treatment, demonstrated superiority compared to control with respect to papules, pustules and 
erythema but not telangiectasia. The formulation was a basic formulation with benzoyl peroxide 
dissolved and delivered in acetone. Irritation and burning was reported in both groups, most likely 
due to the well-known effects of benzoyl peroxide. 
More recently, Breneman et al. 2004 published the results of a study in collaboration with 
J. Leyden. This study was a double-blind, vehicle-controlled study, using a combination gel 
product of 5% benzoyl peroxide and 1% clindamycin to treat patients having moderate to severe 
rosacea. The most dramatic effect of the benzoyl peroxide/clindamycin treatment was on the 
reduction of papules and pustules. Side effects included the well-known effects of benzoyl 
peroxide, burning and itching. 
The most prevalent AEs associated with topical BPO were related to local irritation. These 
included dry skin, peeling, burning and erythema. For the published studies, the percentage of 
subjects with dermatological adverse events considered possibly related to BPO monotherapy 
ranged from 7% (Thiboutot et al. 2007) to 22% (Tschen et al. 2001). In studies sponsored by 
Sol-Gel, the percentage of subjects with dermatological adverse events associated with E-BPO, 
7% ranged from 0% (Study SGT-03B) to 37% (Study SGT-04), and the incidence associated with 
lower concentrations of E-BPO was 2% or less. 


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Several published studies reported AEs that might be associated with sensitivity of subjects to 
BPO. Leyden et al. 2001 reported that 1 of 164 subjects (0.6%) receiving 5% BPO had an 
allergic reaction, and that allergic reactions occurred for 1.2% of subjects receiving 5% BPO 
plus 1% clindamycin and for 3.1% of subjects receiving 5% BPO plus 3% erythromycin. 
Tschen et al. 2001 reported a rash for l of 95 subjects (1%) that received 5% BPO monotherapy. 
Fyrand and Jakobsen 1986 reported that 2 of 49 subjects withdrew from the study due to severe 
dermatitis indicating possible sensitization. Montes et al. 1983 reported hypersensitivity to BPO 
in 4 of 31 subjects receiving 5% BPO acetone gel for rosacea. Weiss et al. 2002 reported that 2 
of 257 subjects receiving BPO plus clindamycin developed urticaria.   In Study KGL 5782, 
1 subject developed possible delayed contact hypersensitivity to both E-BPO, 2.5%, and Proactiv, 
2.5%, indicating the hypersensitivity was probably due to BPO not an excipient. None of these 
events that might possibly indicate sensitization were confirmed by patch testing. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8. 
OBJECTIVE 
The objective of this long-term safety study is to determine the nature, severity and frequency of 
the AE rate, the Cutaneous Safety Assessment and the Local Tolerability Assessment of S5G4T-1 
when applied once daily, if applicable, for up to 52 weeks 
The safety endpoints to be assessed include the following: 
• The frequency of both local and systemic adverse events 
• Investigator Cutaneous Safety Assessment (dryness and scaling) and Local Tolerability 
Assessment (itching and burning/stinging) at Baseline and at all study visits. 


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9. 
ETHICS 
This study will be conducted in compliance with FDA regulations, the ethical principles of the 
Declaration of Helsinki, and the current ICH- Good Clinical Practice (cGCP) guidelines. The 
investigator and all study staff will conduct the study in compliance with this protocol. 
The protocol, informed consent documents, any information provided to patients, recruitment 
advertisements and any amendments to these items will have Institutional Review Board (IRB) 
approval prior to their use in the study. Voluntary informed consent will be given by every patient 
prior to the initiation of any study related procedures. The rights, safety and well-being of the 
study patients are the most important considerations and prevail over the interests of science and 
society. 
All personnel involved in the conduct of this study must be qualified by education, training and 
experience to perform their assigned responsibilities. 


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10. 
INSTITUTIONAL REVIEW BOARD (IRB) AND INFORMED 
CONSENT 
Before study initiation, this protocol, the investigational brochure for encapsulated benzoyl 
peroxide cream (E-BPO) in the treatment of rosacea, the informed consent form, and any other 
written information given to patients, and any advertisement for patient recruitment must have IRB 
approval. The investigator will submit documentation of the IRB approval to the Sponsor, Sol-Gel 
Technologies Ltd., or their CRO designee. 
The IRB-approved consent form must include all elements required by FDA, state, and local 
regulations, and may include appropriate additional elements. 
The investigator/designee will explain the study to each potential patient and the patient must 
indicate voluntary consent by signing and dating the approved informed consent form. The 
consent process will be conducted prior to the start of any study-related procedures including a 
washout period. The investigator must provide the patient with a copy of the consent form, in a 
language the patient understands. 
The investigator will maintain documentation that informed consent was obtained prior to the 
initiation of any study-related procedures. 


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11. 
OVERALL STUDY DESIGN 
Approximately 700 patients will be enrolled at up to 56 sites. All patients in this open-label, 
long-term safety study will be assigned to treatment with S5G4T-1. 
Patients who complete the treatment period of the Phase 3 studies SGT-54-01 or SGT-54-02 will 
be offered to continue into this long-term safety, open-label extension study for up to an additional 
40 weeks. These patients will be admitted into the study and assigned to S5G4T-1 only after 
completing Visit 6/Week 12 within the allowable window (± 4 days) and without protocol 
violation of missing visits (i.e., missing more than one of Visits 3, 4 or 5). 
New patients with moderate to severe rosacea (rated 3 or 4 on the 5-point IGA scale) will be 
enrolled into this long-term safety, open-label study for 52 weeks. These patients will be admitted 
to this study after meeting inclusion/exclusion criteria. Subjects with severe rosacea who are 
appropriate for systemic treatment need to be counseled regarding their treatment options by the 
Principal Investigator. The study will enroll patients who completed the SGT-54-01 and SGT-54- 
02 studies first. Study sites should not enroll new patients into SGT-54-07 until the Sponsor 
provides approval to do so. 
The objective of this study is to determine the long-term safety and tolerability of daily use of 
S5G4T-1 in papulopustular rosacea patients. 
Patients who successfully completed the 12-week treatment period from Study SGT-54-01 or 
Study SGT-54-02 may be offered to continue in the long-term safety, open-label extension study 
(Study SGT-54-07) for up to an additional 40 weeks [sum of up to 52 weeks; 12 weeks treatment 
during the double-blind, pivotal studies (Study SGT-54-01 or Study SGT-54-02) and up to an 
additional 40 weeks in this long-term safety study (Study SGT-54-07)]. The Sponsor may 
terminate the study once 300 patients complete a total of 28 weeks of treatment and 100 patients 
complete a total of 52 weeks. 
Patients who completed Phase 3 studies SGT-54-01 or SGT-54-02 will be admitted into the study 
after the Entry Criteria have been met and an ICF has been signed. Qualified patients will receive 
study product at Baseline visit and treated for up to 40 weeks. New patients will be admitted into 
the study after the Inclusion/Exclusion Criteria have been met. At each visit, the patients will be 
assessed for a 5-point scale IGA of rosacea. If a patient is assessed as “clear” (0) or “almost clear” 
(1), the patient will not be dispensed the study product. If a patient is assessed as “mild”, 
“moderate” or “severe” (2, 3 or 4, respectively), study product will be dispensed, and the patient 
will use the study product daily according to patient instructions. Rosacea Quality of Life 
Questionnaire (RosaQoL) will be completed at Baseline, Visits 5, 8, 11, 14 and at End of Study or 
at early termination. The RosaQoL data of patients who were enrolled from SGT-54-01 or SGT- 
54-02, will be used from the questionnaire completed at Visit 6/Week 12 of SGT-54-01 or SGT- 
54-02. At each visit, the following safety measures will be recorded: monitoring for any AE 
including local and systemic; Investigator Cutaneous Safety Assessment rating of erythema and 
dryness, scaling and Local Tolerability Assessments rating of itching and burning/stinging on a 
scale ranging from 0 (None) to 3 (Severe). 
A urine pregnancy test is required at all Visits for all females of child-bearing potential. 
Clinical Evaluations will be performed at: 
1. Visit 1/Screening, only applies for new patients 


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2. Visit 2/Baseline, Day 1 can also be Visit 6/Week 12, Day 85 of Study SGT-54-01 
or Study SGT-54-02 
3. Visit 3/Week 4, Day 29 (± 10 Days) 
4. Visit 4/Week 8, Day 57 (± 10 Days) 
5. Visit 5/Week 12, Day 85 (± 10 Days) 
6. Visit 6/Week 16, Day 113 (± 10 Days) 
7. Visit 7/Week 20, Day 141 (± 10 Days) 
8. Visit 8/Week 24, Day 169 (± 10 Days) 
9. Visit 9/Week 28, Day 197 (± 10 Days) 
10. Visit 10/Week 32, Day 225 (± 10 Days) 
11. Visit 11/Week 36, Day 253 (± 10 Days) 
12. Visit 12/Week 40, Day 281 (± 10 Days)/ End of Treatment/End of Study for 
patients who complete the study, early terminate, or if the Sponsor terminates the 
study prematurely (applies only to patients who completed Study SGT-54-01 or 
Study SGT-54-02) 
Applies for new patients: 
13. Visit 13/Week 44, Day 307 (± 10 Days) 
14. Visit 14/Week 48, Day 337 (± 10 Days) 
15. Visit 15/Week 52, Day 365 (+ 10 Days)/ End of Treatment/End of Study for 
patients who complete the study, early terminate, or if the Sponsor terminates the 
study prematurely. 
Safety will be assessed by monitoring incidence of Cutaneous Safety Assessment and Local 
Tolerability Assessments, adverse events reporting; at Baseline, and at all treatment and end-of-
treatment visits. The study product will be administered in an open-label fashion, i.e., the 
treatment assignment will be known to the patient, to study personnel and Sol-Gel personnel and 
its representatives. 


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12. 
STUDY POPULATION 
Each patient who signs an informed consent and meets Entry Criteria or Inclusion/Exclusion 
Criteria will be enrolled in the study. Patients will receive study product in an open-label fashion 
(see instructions in Section 13.4) for entire trial period (i.e., the treatment assignment, E-BPO, 5% 
Cream (Encapsulated Benzoyl Peroxide Cream, 5%, S5G4T-1), will be known to the patient, to 
study personnel, Sol-Gel personnel and its representatives. 
12.1. 
Entry Criteria (only applies for patients entering from Phase 3, SGT-54-01 or 
SGT-54-02) 
To be included in the study, patients must meet the following eligibility /inclusion criteria: 
1. Patient must sign an Institutional Review Board (IRB) approved written informed consent for 
the extension study. 
2. Complete 12-week or within the week 12 window time (± 4 days) of the double-blind treatment 
period of study SGT-54-01 or Study SGT-54-02 and missed not more than one visit of Visits 3, 
4 or 5 in Study SGT-54-01 or Study SGT-54-02. 
3. Patients who in the opinion of the investigator, are likely to be able to follow the restrictions 
of the protocol and complete the study. 
12.2. 
Patient Inclusion Criteria (applies only for new patients) 
New patients who were not previously enrolled in Study SGT-54-01 or Study SGT-54-02 must 
meet all the following criteria: 
1. Patient must sign an Institutional Review Board (IRB) approved written informed consent for 
this study. 
2. Male and female 18 years of age and older. 
3. Patients must have clinical diagnosis of moderate to severe rosacea with a Baseline 
Investigator’s Global Assessment (IGA) Score of 3 (moderate severity) or 4 (severe) on a 
severity scale of 0 to 4. 
4. Have a minimum total of 15 and a maximum total of 70 inflammatory lesions (papules and/or 
pustules) including those present on the nose. 
5. Have two nodules or less (nodule defined as a papule or pustule greater than 5 mm in diameter) 
at Baseline. 
6. Patients must be willing and able to understand and comply with the requirements of the study, 
apply the medication as instructed, refrain from use of the following medications (during the 
study, return for the required treatment period visits, comply with therapy prohibitions, and are 
able to complete the study): 
− topical rosacea medication including: Metronidazole 0.75% to 1%, Azelaic acid, 
Brimonidine, Oxymetazoline, Sodium Sulfacetamide 10%, Sulfur 5%, Benzoyl Peroxide, 
Clindamycin, Erythromycin, Benzoyl Peroxide and Clindamycin, Sulfur lotions, retinoids, 
Ivermectin Cream 1%, Ivermectin lotion 0.5%; or 
− topical and systemic (oral and injectable) antibiotics known to impact rosacea e.g., 
tetracycline and its derivatives, erythromycin and its derivatives, doxycycline and its 
derivatives, minocycline and its derivatives, azithromycin and its derivatives, clarithromycin 


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and its derivatives, metronidazole and its derivatives, sulfamethoxazole, or trimethoprim and 
retinoids (e.g., isotretinoin) 
7. Patients must be willing to minimize or not significantly alter controllable external factors that 
might trigger rosacea flare-ups (such as spicy food, thermally hot foods, soups and drinks, hot 
environments, prolonged sun exposure, strong winds, alcoholic beverages, etc.) throughout 
their participation in the study. 
8. Patients must be generally healthy and free from any clinically significant disease, other than 
rosacea, that might interfere with the study evaluations. 
9. Sexually active females of child-bearing potential, excluding women who are sterilized 
(including Essure procedure, tubal ligation, bilateral oophorectomy or hysterectomy) or 
post- menopausal for at least 2 years, must use one of the following birth control options*: 
• Intrauterine device (IUD) 
• Hormonal (injections, implants, transdermal patch, vaginal ring) 
• Abstinence 
• Oral contraceptives 
• Female condom 
• Diaphragm with spermicides 
• Cervical cap with spermicides 
• Contraceptive sponge 
* In addition, patients entering the trial that are on hormonal contraceptives must have been on 
this method for at least 3 months (90 days) prior to the trial and continue the method for the 
duration of the trial. Patients who had used hormonal contraception and stopped must have 
stopped no less than 3 months prior to Baseline. Patients entering the study who had an Essure 
procedure must have had this procedure at least 3 months prior to the study and have undergone 
an Essure confirmation test to ensure its efficacy. A sterile sexual partner is not considered an 
adequate form of birth control. 
12.3. 
Patient Exclusion Criteria (applies only for new patients): 
New patients who were not previously enrolled in Study SGT-54-01 or Study SGT-54-02 must be 
excluded from entry into the study if any of the following criteria are met: 
1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their 
study participation or were found to have positive pregnancy test at baseline or screening visits. 
2. Presence of more than 2 facial nodules or any nodule greater than 1 cm. 
3. Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient 
severity to require topical or systemic antibiotics. 
4. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or 
assessment including but not limited to (e.g., on the face: rosacea conglobata, rosacea 
fulminans, acne vulgaris, acne conglobata, acne fulminans, or secondary acne (chloracne, 
drug-induced acne, etc.), facial pustulosis of the chin, dermatitis (including peri-orbital and 
seborrheic dermatitis), demodicidosis, facial keratosis pilaris, acute lupus erythematosus, 
psoriasis, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, 
sunburn, rhinophyma, or bacterial folliculitis). 


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5. Any uncontrolled, chronic or serious disease or medical condition that would prevent 
participation in a clinical trial or, in judgment of the Investigator, would put the patient at undue 
risk or might confound the study assessments. 
6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with 
diagnosis or assessment of rosacea. 
7. History of unresponsiveness to topical benzoyl peroxide. 
8. Concurrent use of drugs causing acneiform eruptions (e.g., azathioprine, haloperidol, halogens, 
lithium, systemic corticosteroids, phenytoin, phenobarbital, testosterone, anabolic steroids, 
isoniazid). 
9. Known sensitivities to the study product ingredients. Allergy to benzoyl peroxide, parabens 
and glycerin or other ingredients listed in the investigator brochure. 
10. Use: 
− within 180 days prior to Baseline or during the study of oral retinoids (e.g., Accutane®) 
or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are 
allowed). 
− within 90 days prior to Baseline or during the study radiation therapy and/or anti-
neoplastic agents. 
− start or change of dose within 90 days prior to Baseline or during the study of vasodilators, 
vasoconstrictors, anticoagulation or beta-blockers therapy and use throughout the study. 
Use of such therapy must remain constant throughout the study. 
− start or change of dose within 90 days prior to Baseline of hormonal treatment (oral, 
implanted, topical contraceptives and androgens). Use of such therapy must remain 
constant during the study. 
− within 30 days prior to Baseline or during the study of therapeutic Vitamin D supplements 
of greater than 2,000 units/day (daily multivitamins with Vitamin D not exceeding more 
than 2000 IU/day are allowed). If a patient on a constant stable prescribed weekly dose, 
they should remain on this dose during the study. 
− within 30 days prior to Baseline or during the study of (1) systemic steroids, (2) topical 
retinoids to the face (e.g., tretinoin) (3) systemic (e.g., oral or injectable) antibiotics 
known to impact rosacea (e.g., tetracycline and its derivatives, erythromycin and its 
derivatives, doxycycline and its derivatives, minocycline and its derivatives, macrolides 
and its derivatives, azithromycin and its derivatives, clarithromycin and its derivatives, 
metronidazole and its derivatives, sulfamethoxazole, bactrim or trimethoprim); short term 
treatment of all other antibiotics (not affecting rosacea for) ≤ 14 days for non-rosacea 
related conditions is acceptable, (4) immunosuppressive agents, or immunomodulators 
(e.g. cyclosporine, tacrolimus, pimecrolimus). 
− of medicated make-up (including anti-aging make-up) throughout the study and 
significant change in the use of consumer products within 14 days of study entry and 
throughout the study. 
− of niacin and niacinamide (Vitamin B3) within 24 hours of study entry and throughout 
the study. 
− of intranasal and inhaled corticosteroids do not require a washout and may be used 
throughout the study if at a stable and standard dose. 


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11. Facial use within 14 days prior to Baseline or during the study of (1) topical steroids, (2) topical 
anti-inflammatory agents or topical non-steroidal anti-inflammatory drugs (NSAID), (3) 
topical antimycotics, (4) any topical rosacea treatments (e.g., Metronizadole 0.75% to 1%, 
Azelaic acid, Brimonidine, Oxymetazoline, Sodium Sulfacetamide 10%, Sulfur 5%, Benzoyl 
Peroxide, Clindamycin, Erythromycin, Benzoyl Peroxide and Clindamycin, Sulfur lotions, 
Retinoids, Ivermectin) or (5) topical antibiotics. 
12. Use on the face within 30 days prior to Baseline or during the study of (1) cryodestruction or 
chemodestruction, (2) dermabrasion, (3) photodynamic therapy, (4) acne surgery, (5) 
intralesional steroids, (6) laser resurfacing or electrodessication, (7) x-ray therapy, (8) pulse 
dye laser, (9) long-pulsed Nd-YAG laser, (10) Intense pulse light or pulse light laser, (11) 
electrocautery or electrocoagulation, (12) CO2 laser, Fractioned lasers, or loop electrosurgery, 
(13) facial peels or other facial cosmetic surgery (e.g., Thermage®, etc.). 
13. Use of medicated cleansers on the face (e.g., benzoyl peroxide, salicylic acid, sulfur or 
triclosan) within 7 days of Baseline and throughout the study. 
14. Patient consumes excessive alcohol, abuses drugs, or has a condition that could compromise 
the patient’s ability to comply with study requirements and/or have drug or alcohol addiction 
requiring treatment in the past 12 months. 
15. Use of topical astringents or abrasives (e.g., rubs, exfoliating cleansers and products containing 
salicylic acid and/or alcohol), topical preparations that contain spices or lime, medicated 
topical preparations (prescription and OTC products) within 7 days prior to Visit 2 (Baseline) 
and throughout the study. 
16. Use of antipruritics (including antihistamines), spa or sauna treatments or chlorine exposure 
(swimming pool etc.) within 24 hours (1 day) of all study visits (Visit 2, Baseline, through End 
of Study). 
17. Participation in any clinical study involving an investigational product, agent or device that 
might influence the intended effects or mask the side effects of study product, within 30 days 
prior to Visit 2 (Baseline) and throughout the study. 
18. Previous enrollment in this study or current enrollment in this study at another participating 
site. 
19. Employee (or employee’s family member) of the research center or private practice, or patients 
who have a conflict of interest. 
20. Patients living (e.g., siblings, spouses, relatives) in the same household cannot be enrolled in 
the study at the same time. 
21. Use of tanning booths, sun lamps or excessive UV radiation (e.g., phototherapy, daily extended 
exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 
week (7 days) prior to Baseline and throughout the study. 
22. Patients who in the opinion of the investigator, are unlikely to be able to follow the restrictions 
of the protocol and complete the study. 
12.4. 
Prohibited, Previous and Concomitant Therapies 
12.4.1. 
Patients entering from Phase 3, SGT-54-01 or SGT-54-02 
Any rosacea therapies must not be used as specified below: 


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• Therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are 
allowed). 
• Use of antipruritics (including antihistamines), spa or sauna treatments or chlorine 
exposure (swimming etc.) within 24 hours (1 day) before of all study visits (Visit 2 through 
End of Study. 
• Use of medicated cleansers on the face (e.g., benzoyl peroxide, salicylic acid, sulfur or 
triclosan). 
• Topical anti-rosacea treatments. 
• Topical antibiotics, antimicrobials. 
• Topical anti-inflammatories on the face such as corticosteroids and non-steroidal anti-
inflammatory drugs (NSAID). 
• Topical retinoids. 
• Systemic rosacea treatments, corticosteroids, antibiotics. 
• Systemic retinoids. 
12.4.2. 
New Patients 
Any rosacea therapies must not be used as specified below: 
• Topical astringents or abrasives or preparations that contain spices or lime, medicated 
topical preparations applied to the face (prescription and OTC products) within 7 days prior 
to Baseline. 
• Use of medicated cleansers on the face (e.g., benzoyl peroxide, salicylic acid, sulfur or 
triclosan) within 7 days of Baseline. 
• Topical anti-rosacea treatments – 2 weeks prior to Baseline. 
• Topical antibiotics, antimicrobials – 2 weeks prior to Baseline. 
• Topical anti-inflammatories on the face such as corticosteroids, vasoconstrictors and 
non-steroidal anti-inflammatory drugs (NSAID) – 2 weeks prior to Baseline. 
• Topical retinoids – 30 days prior to Baseline. 
• Systemic rosacea treatments, corticosteroids, antibiotics – 30 days prior to Baseline. 
• Systemic retinoids – 6 months prior to Baseline. 


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12.4.3. 
All Patients 
Other than the study products, no other topical medications are permitted to be used on the face. 
All topical or systemic medications listed above are prohibited. Other prohibited treatments 
include but are not limited to astringents, toners, clarifying lotions, medicated shaving products, 
chemical peeling products used on the face. A stable regimen of inhaled corticosteroids for stable 
medical conditions and antibiotic treatment are allowed during the study. No medicated cleansers 
or moisturizers are allowed on the face. Only study provided, or approved cleanser and 
moisturizer/sunscreen will be allowed to be used on the face during the study. Study product shall 
be applied to clean skin and no cleanser should be applied to the face within two hours of study 
product application. Provided or approved moisturizer/sunscreen may be applied after 30 minutes 
or more of study product application. Patients who use make-up must have used the same 
brands/types of make-up for a minimum period of 1 month (30 days) prior to study entry and must 
agree to not change make-up brand/type throughout the study. Patients should not apply the 
moisturizer or sunscreen or combination of them or wear make-up during study visits as it may 
interfere with the evaluator’s assessments. 
All concomitant therapies used during the study must be recorded on the Concomitant Therapy 
electronic case report form (eCRF). 
Therapies (medication and non-medication therapies) not restricted by the protocol may be used 
during the study for the treatment or prevention of disease or to maintain good health. Vitamins 
and mineral supplements are permitted at dosages considered by the investigator as reasonable for 
maintaining good health. Non-prohibited chronic therapies being used at Screening (Visit 1) for 
new patients OR at Baseline (visit 2) for patients proceed from SGT-54-01 or SFGT-54-02 may 
be continued. Patients may use systemic anti-inflammatory agents [i.e., NSAIDs (ibuprofen or 
aspirin) for pain relief] as needed (with no more than 7 days of consecutive use) throughout the 
study. Prophylactic use of low dose aspirin (81 mg) is allowed. Patients may use acetaminophen 
for pain relief, as needed throughout the study. 
Any changes in concomitant therapies during the study must be recorded on the Concomitant 
Therapy form at each visit. The reason for any change in concomitant therapies should be reported 
as, or in conjunction with, an adverse event except as noted below: 
• Prophylactic therapies, such as vaccines, must be recorded on the Concomitant Therapy 
form, but the reasons for these therapies should not be reported as adverse events. 
• Changes in therapy for pre-existing conditions that are not related to a worsening of the 
condition must be reported on the Concomitant Therapy form, but the reasons for these 
changes should not be reported as adverse events. The condition must be reported in the 
Medical History. 
If a patient receives prohibited treatment during the study, the patient may be allowed to continue 
in the study at the discretion of the investigator and Sponsor / Medical Monitor. 
Patients should avoid UV exposure by sun bathing or tanning parlors. 


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12.5. 
Precautions 
The following precautions are to be taken during this study: 
1. Patients should avoid contact of the study product with the eyes, mouth, and lips or on any cuts 
or broken skin. In case of accidental exposure, the eyes should be rinsed with plenty of water. 
2. The study product should not be applied to cuts, abrasions, eczematous or sunburned skin. 
3. Patients should wash hands before and after applying study product. 
4. Patients should allow the treated area to completely dry for at least 30 minutes after applying 
the study product (before going to bed) to avoid spreading it on other areas of the face (e.g., 
eyes, ears, neck, etc.) and pillow cases. 
5. The study product should be spread evenly in a thin layer on each area of the face (chin, left 
cheek, right cheek, nose, left forehead and right forehead); excessive rubbing must be avoided. 
6. The study product should not be applied more than once daily, and patients should not use 
more than the recommended amount. 
7. Patients should not wash their face more than 2 or 3 times a day. 
8. Facial makeup (non-medicated) may be applied according to the patient’s normal daily routine 
(but not prior to 30 minutes after study product application. 
9. Patients should not apply moisturizers, make-up, creams, lotions, powders or any topical 
product they do not routinely use on their face 
10. Patients should not cover the treated area with a bandage (occlusive dressing) or other types of 
dressing after applying the study product. 
11. Patients should limit sun exposure, including sunlamps (non-prescription UV light sources); 
avoid tanning beds/booths/parlors and sauna while using the study product. 
12. Patient should use study provided/approved moisturizer with SPF (minimum of SPF 15) and 
protective apparel (e.g. wide- brimmed hat) when outdoors. Patients should wait 
approximately 30 minutes after study product is applied on the face before applying a 
sunscreen. Weather extremes, such as wind or cold, may be irritating to patients receiving 
treatment. 
13. UVA/UVB treatments are also prohibited. 
14. Patients must not wear make-up to any study visits, so as not to interfere with the evaluations. 
If a patient comes to his/her visits with make-up on his/her face, the patient will be allowed to 
wash his/her face with a non-medicated cleanser and must wait at least 30 minutes before any 
study evaluation is made by the Principal Investigator (PI) or Sub-Investigator (Sub-I). 
15. Patients should consult the investigator with any questions regarding concomitant medications. 
16. Abrasive cleansers or washes, alcoholic toners, astringents are prohibited throughout the study. 
17. “Waxing” as a depilatory method should be avoided on skin treated with study product. 
18. Patients should be informed that local skin reactions [dryness, burning/stinging, pruritus 
(itching), scaling/peeling] may occur. 


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19. Patients should minimize or not significantly alter consumption of any foods and beverages 
that might provoke erythema, flushing, and blushing (including spicy food, alcoholic 
beverages, and thermally hot drinks, including hot coffee and tea) throughout the study. 


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13. 
STUDY PROCEDURES 
13.1. 
Study Patient Identification 
Patients entering from Phase 3, SGT-54-01 or SGT-54-02 will continue with the same number 
identification he/she received from study SGT-54-01 or SGT-54-02. When new patients sign an 
informed consent, he/she will be assigned a three (3)-digit patient number beginning with 
, as 
well as the 3-digit site number (e.g., 
). In these studies, the complete patient ID consists of 
the 3-digit site number followed by the 3-digit patient number: e.g., 
 (first patient screened 
at site 
). This number will remain with the patient for the duration of the study and will not be 
reassigned to another patient. 
13.2. 
Screen Failure and Discontinuation Criteria 
For new patients, a screen failure is a patient who is not randomized/enrolled in the study due to 
ineligibility, after signing an Informed Consent Form, and did not receive study product. The 
Informed Consent Form signed by the patient should be kept with the source document for patients 
who do not pass the screening procedures. The documentation should include identification of the 
eligibility criterion or criteria that were and were not met. The patient should not be re-screened 
for this study without Sol-Gel’s approval. 
Although encouraged to complete the study whenever possible, patients are free to discontinue 
their participation in this study at any time and for any reason without prejudice. A patient may 
be withdrawn from the study prior to study completion for any of the following reasons: 
• Investigator opinion that it is not in the patient’s best interest to continue. 
• Patient Request /Withdraw Consent – Whenever the patient decides it is in his/her best 
interest to withdraw. 
• Adverse Event – when the investigator thinks it’s in the patient’s best interest 
• Lost to Follow-up – Documentation confirmed at minimum by two phone calls and 
certified letter. Best effort should be performed to capture an explanation for the lost-to 
follow-up event. 
• Protocol Violation – When requirements of the protocol are not respected, especially when 
patient safety is concerned. 
• Pregnancy 
• 
Worsening of condition that requires alternate therapy. 
In the event that the Sponsor terminates the study early, every effort will be made to allow patients 
to complete at least 6 months of treatment. 
In the case of patients who discontinue due to an Adverse Event, the Investigator will conduct 
follow-up contacts with the patient until the Investigator, Sponsor and Medical Monitor agree the 
event is satisfactorily resolved and/or stabilized. 
Patients discontinued early from the study shall not be replaced. 


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13.3. 
Patient Screening and Enrollment 
The study personnel will review the IRB approved informed consent form with each patient and 
give the patient an opportunity to have all questions answered before proceeding. The consent 
form must be signed by each patient before the patient is enrolled into the study. A copy of the 
signed consent will be given to every patient (or legally authorized representative) and the original 
will be maintained with the patients’ records. 
Patients that require a wash-out of more than 35 days from their initial informed consent/assent 
signing must be re-consented before any further study procedures can begin. 
13.4. 
Method of Treatment Assignment 
The patient assignment schedule will be a stratified by investigational site. Patients will be 
assigned through the IWRS a unique ID indicating pump number. The format of the supplied 
number of pump is XXXX. At each visit the patient will return the pump and will be dispensed 
the next pump according to the IWRS assignment. 
13.5. 
Demographics/Medical History 
A demographic profile and complete medical history will be recorded prior to starting study 
product. The medical history will include a complete review of all current diseases and their 
respective treatments. For patients who continue from Phase 3, SGT-54-01 or SGT-54-02, a 
demographic profile and complete medical history will be recorded   at Visit 2 in the 
Study SGT-54-07 source document. New patients will have demographic profile done at Visit 
1/Screening and medical history done at Visits 1/Screening and 2/Baseline. Any adverse events 
that might be ongoing or chronic or new medical history should be also recorded. 
13.6. 
Concomitant Medications 
Concomitant medications taken prior to signing informed consent will be recorded as 
prior/concomitant medications (using their generic name, if known) with the corresponding 
indication. The medications to be recorded will include prescription and over-the-counter (OTC) 
medications and dietary supplements. All medications taken on either a regular or “prn” basis, 
including vitamins, aspirin and acetaminophen, should be recorded on this page prior to 
commencing the use of the study product. 
13.7. 
Physical Examination 
The investigator, sub-investigator or appropriately delegated and qualified designee will perform 
a brief physical examination, prior to the patient starting study product. The exam will include 
heart, lung, abdomen evaluation as well as recording height, weight and vital signs. Vital signs 
are to include sitting blood pressure, oral temperature, heart rate and respiratory rate. Brief 
physical examination will be performed by the investigator, sub-investigator or appropriately 
delegated and qualified designee every 12 weeks. For patients who enter from Phase 3, SGT-54- 
01 or SGT-54-02, the first physical examination of this study is the same as the Visit 6 examination 
from Study SGT-54-01 or Study SGT-54-02. A photocopy of the Visit 6 physical examination will 
be placed in the SGT-54-07 source document. 


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13.8. 
Urine Pregnancy Test 
Females of childbearing potential (excluding women who are surgically sterilized or post-
menopausal for at least 2 years), in addition to having a negative urine pregnancy test, must be 
willing to use an acceptable form of birth control during the study. An investigator could repeat the 
pregnancy test at any time during the study if there is any suspicion or possibility that the patient 
is pregnant. Urine pregnancy test will also be conducted every 4 weeks starting at Visit 
1/Screening or Visit 2/Baseline until End of Treatment/Early Termination Visit. For patients who 
proceed from a Phase 3 study, SGT-54-01 or SGT-54-02, the first urine pregnancy test of this 
study is the same as the Visit 6 examination from Study SGT-54-01 or Study SGT-54-02. A 
photocopy of the Visit 6 Urine Pregnancy Test will be placed in the SGT-54-07 source document. 
For the purpose of this study, the following are considered acceptable methods of birth control: 
intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); 
abstinence; oral contraceptives; female condom; diaphragm with spermicides; cervical cap with 
spermicides; contraceptive sponge. 
Patients entering the trial that are on hormonal contraceptives must have been on this method for 
at least 3 months (90 days) prior to the trial and continue the method for the duration of the trial. 
Patients who had used hormonal contraception and stopped must have stopped no less than 3 
months prior to Baseline. Patients entering the study who had an Essure procedure must have had 
this procedure at least 3 months prior to the study and have undergone an Essure confirmation test 
to ensure its efficacy. A sterile sexual partner is not considered an adequate form of birth control. 


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13.9. 
Study Flow Chart for patients who entered from Study SGT-54-01 or SGT-54-02 
 
Procedure 
Visit 21,2,7 
Visit 3, 4, 6, 7, 9, 10 
Visit 5, 8, 11 
Visit 12 
(EOT3/ EOS4) 
Unscheduled 
Visit11 
Name of Visit 
Baseline 
Day 1 
Week 4, 8, 16, 20, 28, 325 
Day 29, 57, 113, 141, 197, 225 
Week 12, 24, 365 
Day 85, 169, 253 
Week 40 
Day 2816 
Visit window 
± 10 days 
± 10 days 
± 10 days 
Entry Criteria 
X 
Sign Informed Consent 
X 
Demographics 
X 
Medical History 
/Previous Therapies 
X 
Con med 
X 
X 
X 
X 
X 
Pregnancy Test7 
X 
X 
X 
X 
X 
Brief Physical 
Examination 
X 
X 
X 
X 
Cutaneous Safety 
Assessment and Local 
Tolerability 
Assessments 
X 
X 
X 
X 
X 
Administer/ Review 
Patient Instructions 
X 
X 
X 
X 
IGA8 
X 
X 
X 
X 
X 
Rosacea Erythema 
Assessment 
X 
X 
X 
X 
X 
Telangiectasia 
Assessment 
X 
X 
X 
X 
X 
Weigh Study Product 
X 
X 
X 
X 
X 
Study Product 
Dispensed9 
X 
X 
X 
X 
Provide Cleanser and 
Moisturizer/Sunscreen, 
if needed 
X 
X 
X 
X 
Study Product 
Collected 
X 
X 
X 
Diary Card dispensed 
X 
X 
X 
X 
Diary Card collected 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Complete RosaQoL10 
X 
X 
X 
 
 
 
 
 
 
1 Patient will be eligible for the extension study only after completing 12 weeks of one of the two Phase 3 studies SGT-54-01 or SGT-54-02 at 
the Week 12 window time (± 4 days) and missed not more than one visit of Visits 3, 4 or 5 in these studies. 
2 Same Visit as Visit 6 in Phase 3 Study SGT-54-01 or Study SGT-54-02. All procedures that were performed in Visit 6 of Study SGT-54-01 or 
Study SGT-54-02 will be captured in the Study SGT-54-07 source document. 
3 EOT – end of treatment. 
4 EOS – end of study. 
5      All visits must be in reference to baseline and counted accordingly. 
6      All Week 40 procedures should be completed for Patients who terminate early. 
7      Urine test for women of childbearing potential. 
8 For product dispensing eligibility 
9 The dispensation and usage of the pump is based on IGA score. 
10 RosaQoL is a Rosacea Quality of Life questionnaire 
11 Perform procedures per PI discretion. 


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13.10. 
Study Flow Chart for new patients only 
 
Procedure 
Visit 11 
Visit 2 
Visit 3, 4, 6, 7, 9, 10, 
12, 13 
Visit 5, 8, 11, 
14 
Visit 15 
(EOT2/ 
EOS3) 
Unscheduled 
Visit9 
Name of Visit 
Screening 
-35 to 0 
Baseline 
Day 1 
Week 4, 8, 16, 20, 28, 
32, 40, 44 Day 29, 57, 
113, 141, 197, 225, 281, 
309 
Week 12, 24, 
36, 48 
Day 85, 169, 
253, 337 
Week 52 
Day 3654 
Visit window 
± 10 days 
± 10 days 
± 10 days 
Inclusion/Exclusion 
Criteria 
X 
X 
Demographics 
X 
Medical 
History/Previous 
Therapies 
X 
X 
Sign Informed Consent 
X 
Brief Physical 
Examination 
X 
X 
X 
X 
Concomitant Therapy 
and Medication History 
Reviewed 
X 
X 
X 
X 
X 
X 
Pregnancy Test5 
X 
X 
X 
X 
X 
X 
Cutaneous Safety 
Assessment and Local 
Tolerability 
Assessments 
X 
X 
X 
X 
X 
Administer/ Review 
Patient Instructions 
X 
X 
X 
X 
IGA6 
X 
X 
X 
X 
X 
X 
Inflammatory Lesion 
Count 
X 
X 
Rosacea Erythema 
Assessment 
X 
X 
X 
X 
X 
Telangiectasia 
Assessment 
X 
X 
X 
X 
X 
Weigh Study Product 
X 
X 
X 
X 
X 
Study Product 
Dispensed7 
X 
X 
X 
X 
Provide Cleanser and 
Moisturizer/ 
Sunscreen, if needed 
X 
X 
X 
X 
Study Product Collected 
X 
X 
X 
Diary Card dispensed 
X 
X 
X 
X 
Diary Card collected 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
Complete RosaQoL8 
X 
X 
X 
 
 
 
 
1 Patient will be eligible for the study only after meeting all Inclusion/Exclusion criteria. 
2 EOT – end of treatment. 
3 EOS – end of study. 
4      All Week 52 procedures should be completed for Patients who terminate early. 
5      Urine test for women of childbearing potential. 
6 For product dispensing eligibility 
7 The dispensation and usage of the pump is based on IGA score. 
8 RosaQoL is a Rosacea Quality of Life questionnaire 
9 Perform procedures per PI discretion. 


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13.11. 
Screening Visit (Visit 1) for new patients only 
If no washout is needed, Visits 1 (Screening) and 2 (Baseline) may occur on the same day. If a 
washout is needed, Visit 2 (Baseline) must occur within 36 days of Visit 1 (Screening). The 
following procedures will be conducted at this visit: 
• Obtain a signed and dated, written informed consent for all patients prior to any study 
related procedures. 
• Confirm the patient meets the inclusion/exclusion criteria as outlined in Section 12.2 and 
Section 12.3 
• Record Demographics and Medical History 
• Record any adverse events 
• Perform a urine pregnancy test for all females of childbearing potential (see Section 13.8); 
the results must be negative for the patient to be enrolled 
• Report the medical history and demographics for the patient 
• Record the patient’s concomitant medications and/or therapies on Concomitant Therapy 
form as outlined in Section 13.6 
• Perform investigator’s global assessment (IGA) to determine eligibility (See Section 14.1) 
• Perform facial inflammatory lesion counts to determine eligibility: (Section 14.2) 
 
Determine if patient requires washout and schedule Baseline Visit 
13.12. 
Baseline Visit (Visit 2, Day 1) 
The following procedures will be conducted at this visit: 
• Obtain a signed and dated, written informed consent for all patients prior to any study 
related procedures 
• Confirm the patient meets Entry Criteria for patients to proceed from Studies SGT-54-01 
or SGT-54-02 as outlined in Section 12.1or Inclusion/Exclusion criteria for new patients 
as outlined in Section 12.2 
• Ask the patient to complete Rosacea Quality of Life (RosaQoL) questionnaire (see 
Appendix 0). If the questionnaire was performed at the Visit 6/End of Treatment Visit of 
SGT-54-01 or SGT-54-02, attach a copy of the questionnaire to the source document 
• Record Demographics and Medical History (For patients who continue from Phase 3, SGT- 
54-01 or SGT-54-02, a demographic profile and complete medical history will be recorded 
at Visit 2 in the Study SGT-54-07 source document) 
• Record any adverse events 
• Perform brief physical examination as described in Section 13.7 (If the last physical 
examination was done at Visit 6/End of Treatment Visit of SGT-54-01 or SGT-54-02 
studies, attach a copy of it to the source document) 
• Perform a urine pregnancy test for all females of childbearing potential (see Section 13.8); 
the results must be negative for the patient to be enrolled. (If the last urine pregnancy test 
was done at Visit 6/End of Treatment Visit of SGT-54-01 or SGT-54-02 studies, attach a 
copy of it to the source document) 


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• Record the patient’s concomitant therapies on Concomitant Therapy form as outlined in 
Section 13.6 
• Perform Cutaneous Safety Assessment and Local Tolerability Assessment as described in 
Sections 15.1 to 15.2 (If the assessments were taken at Visit 6/End of Treatment Visit of 
SGT-54-01 or SGT-54-02 studies, attach a copy of the assessments to the source document) 
• Perform the IGA, described in Section 14.1, rosacea erythema assessment and 
telangiectasia assessment, described in Sections 14.2 to 14.4. (If the assessments were 
performed at the Visit 6/End of Treatment Visit of SGT-54-01 or SGT-54-02, attach a copy 
of the assessments to the source document) 
• Perform the inflammatory lesion count, described in (Section 14.2) for new patients only 
• Weigh the study product before dispensing 
• Instruct the patient on the study product application as described in Appendix 1. For new 
patients, pump usage shall be demonstrated by the site personnel on a sample pump at the 
clinic to help assure the patient understands the procedure 
• Dispense the patient Instruction Sheet and Diary Card to the patient (see Appendix 1 for 
appropriate instructions for study patients) 
• Dispense cleanser and moisturizer with sunscreen 
• Instruct the patient that throughout the study overexposure of the face to sunlight should 
be avoided. Instruct the patient to use the sunscreen provided or approved; any exposure 
to tanning beds must be avoided during the study 
• Assign study product by using IWRS 
• Dispense study product pump to patient 
• Remind patient to not wear make-up to all subsequent visits 
• Schedule the next study visit 
13.13. 
On-treatment (Visit 5, 8, 11; for new patients only: 14) – week 12, 24, 36; for new 
patients only: 48 - Day 85, 169, 253; for new patients: 337 (± 10 days) 
The following procedures will be conducted at each visit: 
• Ask the patient to complete Rosacea Quality of Life (RosaQoL) questionnaire (see 
Appendix 0) 
• Observe and query the patient in a non-directive fashion about any adverse events since 
the previous study visit 
• Query the patient about any changes in concomitant therapies since the previous study visit 
and update the Concomitant Therapy eCRF 
• Perform the IGA described in Section 14.1, rosacea erythema assessment and 
telangiectasia assessment described in Sections 14.2 to 14.4 
• Perform Cutaneous Safety Assessment and Local Tolerability Assessment as described in 
Sections 15.1 to 15.2 
• Perform a urine pregnancy test for all females of childbearing potential (see Section 13.8) 
• Perform a brief physical examination 


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• Review the patient’s compliance with the study requirements; collect and review the 
Patient Diary Card 
• Dispense a Diary Card to the patient 
• Dispense cleanser and moisturizer with sunscreen if needed 
• Record number of missed doses on the appropriate eCRF page 
• Review the study product application instructions with the patient 
• Collect and weigh returned study product pump 
• Weigh and dispense the next pump of study product. 
Remind patient to not wear make-up to all subsequent visits 
13.14. 
On-treatment (Visit 3, 4, 6, 7, 9, 10; for new patients: 12, 13) – Week 4, 8, 16, 20, 
28, 32; for new patients: 36, 40, 44 - Day 29, 57, 113, 141, 197, 225; for new 
patients: 281, 309 (± 10 days) 
The following procedures will be conducted at each visit: 
• Observe and query the patient in a non-directive fashion about any adverse events since 
the previous study visit 
• Query the patient about any changes in concomitant therapies since the previous study visit 
and update the Concomitant Therapy eCRF 
• Perform the IGA described in Section 14.1, rosacea erythema assessment and 
telangiectasia assessment described in Sections 14.2 to 14.4 
• Perform Cutaneous Safety Assessment and Local Tolerability Assessment as described in 
Sections 15.1 to 15.2 
• Perform a urine pregnancy test for all females of childbearing potential (see Section 13.8) 
• Review the patient’s compliance with the study requirements; collect and review the 
Patient Diary Card 
• Dispense a Diary Card to the patient 
• Dispense cleanser and moisturizer with sunscreen if needed 
• Record number of missed doses on the appropriate eCRF page 
• Review the study product application instructions with the patient 
• Collect and weigh returned study product pump 
• Weigh and dispense the next pump of study product. 
• 
Remind patient to not wear make-up to all subsequent visits 
• Schedule/confirm the next study visit 


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13.15. 
Patients Who entering from Studies SGT-54-01 or SGT-54-02: End of Treatment 
(Visit 12) – Week 40, Day 281 (± 10 days) or Early Termination by the Patient or 
Sponsor. New Patients: End of Treatment (Visit 15) – Week 52, Day 365 
(± 10 days) or Early Termination by the Patient or Sponsor 
The following procedures will be conducted at this visit: 
• Ask the patient to complete Rosacea Quality of Life (RosaQoL) questionnaire (see 
Appendix 2) 
• Observe and query the patient in a non-directive fashion about any adverse events since 
the previous study visit 
• Query the patient about any changes in concomitant therapies since the previous study visit 
and update the Concomitant Therapy eCRF 
• Perform brief physical examination as described in Section 13.7 
• Perform efficacy evaluations: IGA described in Section 14.1, rosacea erythema assessment 
and telangiectasia assessment described in Sections 14.2 to 14.4 
• Perform Cutaneous Safety Assessment and Local Tolerability Assessment as described in 
Sections 15.1 to 15.2 
• Perform a urine pregnancy test for all females of childbearing potential (see Section 13.8) 
• Review the patient’s compliance with the study requirements 
• Collect and review the Patient Diary Card 
• Record number of missed doses on the appropriate eCRF page 
• Collect and weigh returned study product pump 
• Complete the End of Study/Study Termination eCRF 
• Discharge the patient from the study 
13.16. 
Unscheduled Visit 
An unscheduled visit is allowed at any time if in the investigator’s opinion it is warranted. The 
following procedures may be performed at the unscheduled visit, if required. 
• Observe and query the patient in a non-directive fashion about any adverse events since 
the previous study visit 
• Query the patient about any changes in concomitant therapies since the previous study visit 
and update the Concomitant Therapy eCRF 
• Perform brief physical examination and vital signs as described in Section 13.7 
• Perform a urine pregnancy test 
• Perform the IGA described in Section 14.1, rosacea erythema assessment and 
telangiectasia assessment described in Sections 14.2 to 14.4 
• Perform Cutaneous Safety Assessment and Local Tolerability Assessment as described in 
Sections 15.1 to 15.2 
• Review the patient’s compliance with the study requirements; collect and review the 
Patient Diary Card 
• Dispense a Diary Card to the patient 


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• Dispense cleanser and moisturizer with sunscreen if needed 
• Review the study product application instructions with the patient 
• Weigh and dispense the next pump of study product 
• Remind patient to not wear make-up to all subsequent visits 
• Schedule/confirm the next study visit 


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14. 
CLINICAL OUTCOME ASSESSMENTS 
14.1. 
Investigator Global Assessment (IGA) 
The IGA will be performed at all study visits. 
If a patient is assessed as “clear” (0) or “almost clear” (1), the patient will not be dispensed the 
study product. If a patient is assessed as “mild”, “moderate” or “severe” (2, 3 or 4, respectively), 
study product will be dispensed and the patient will use the study product daily according to patient 
instructions. 
In the event a subject is not dispensed IP at a given visit due to an IGA of "clear" or "almost clear," 
and the subject's rosacea condition worsens, an unscheduled visit can be performed for assessing 
the subject and dispensing IP, if appropriate. 
The IGA scale provided in Table 1 will be used to describe the severity grade and subsequent 
score: 
 
Table 1: Investigator Global Assessment (IGA) Scale 
 
Grade 
Description 
0 – Clear 
Skin clear of inflammatory papules or pustules 
1 – Almost Clear 
Very few small papules or pustules and very mild dull erythema is present 
2 – Mild 
Few small papules or pustules and mild dull or light pink erythema is present 
3 – Moderate 
Several to many small or larger papules or pustules and moderate light to bright red 
erythema is present 
4 – Severe 
Numerous small and/or larger papules or pustules and severe erythema that is bright red to 
deep red is present 
 
14.2. 
Inflammatory Lesion Counts 
Inflammatory lesions (papules and pustules) counts will be performed at Screening and Baseline, 
for new patients only, and they must have at least 15 and not more than 70 inflammatory lesions 
(papules, pustules) on the face. 
Papules and pustules are defined as follows: 
• Papule – A solid, elevated inflammatory lesion equal to or less than 5 mm in diameter 
• Pustule – An elevated inflammatory lesion equal to or less than 5 mm in diameter, contains 
pus (yellow-white exudate) 
Nodules will not be included in the inflammatory lesion count and are defined as: 
• Nodule/Cyst – Palpable solid inflammatory lesion, greater than 5 mm in diameter, has 
depth, not necessarily elevated 
14.3. 
Erythema Severity Assessments 
Erythema is defined as redness of the skin. It will be scored on a scale of 0 (none) to 3 (severe) at 
Baseline, and at all the study visits except the screening visit. The Rosacea Erythema Assessment 
Scale is provided in Table 2. 


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Table 2: Rosacea Erythemaa Assessment Scale 
 
Grade 
Description 
0 – None 
No visible erythema 
1 – Mild 
Slight erythema (dull or light pink), centro-facial 
2 – Moderate 
Definite erythema (light to bright red), either centro-facial or generalized to whole face 
3 – Severe 
Severe erythema (bright red to deep red), either centro-facial or generalized to whole face 
a Generalized erythema associated with rosacea 
 
 
14.4. 
Telangiectasia Assessment 
Facial telangiectasia will be evaluated on a scale of 0 to 3 at Baseline, and at all the study visits 
except the screening visit; the Telangiectasia is provided in Table 3. 
 
 
Table 3:   Telangiectasia Assessment Scale 
 
Grade 
Description 
0 – None 
No Telangiectasia 
1 – Mild 
Only a few fine vessels discernible, involves approximately 10% or less of facial area 
2 – Moderate 
Multiple and more prominent fine vessels, involves approximately 10 – 30% of the facial 
area 
3 – Severe 
Numerous and prominent fine and/or courser vessels, involves more than 30% of the facial 
area 
14.5. 
Rosacea Quality of Life (RosaQoL) 
RosaQoL questionnaire will be taken at Baseline, Visits 5, 8, 11, 14 and at the End of Study Visit. 
There is a symptom subscale with seven questions (items 2, 6, 9, 16, 17, 18 and 19 in Appendix 
2) , a functional subscale with 3 questions (items 13, 15 and 21 in Appendix 2) and an emotion 
subscale with 11 questions (items 1, 3, 4, 5, 7, 8, 10, 11 12, 14 and 20 in Appendix 2) to be 
administered in the study. The questionnaire will be administered to all patients during the 
designated study visits with the appropriate instructions from the Study Staff. The questionnaire 
should be completed: 
• Only by the patient without amendment or interpretation of the patient’s response by a 
clinician or anyone else. 
• Prior to any other assessments or procedures. 
In the event the patient skips any questionnaire items; the Study Staff will ask the patient to 
complete the form. The RosaQoL questionnaire data will be entered into the EDC system by the 
Study Staff, and a copy will be placed with the patient source documents at the site according to 
the ICH-GCP guideline (4.9.5). 
All items should be scored for the following answers: 
• Never: 1 


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• Rarely: 2 
• Sometimes: 3 
• Often: 4 
• All the time:5 
 
The Site Staff and anyone else provided with a copy of the RosaQoL instrument for the purpose 
of the study will be instructed that the RosaQoL instrument is protected by Common Law 
copyright. No part of this may be reproduced or transmitted in any form or by any means, now 
known or to be invented or adapted, for purpose of financial gain or profit. 
An overall total score will be calculated; this score will be the unweighted mean of all RosaQoL 
questions. In addition to the total score, each subscale (symptom, functional and emotion) will 
also have a score calculated; these scores will the unweighted mean of the group of questions that 
comprise the subscale. Further details on the handling of missing responses and calculation of the 
subscale scores will be detailed in the Statistical Analysis Plan (SAP). 


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15. 
SAFETY EVALUATIONS 
Safety will be assessed by monitoring incidence of Cutaneous Safety Assessment, Local 
Tolerability Assessment and adverse events reporting at all visits. 
15.1. 
Cutaneous Safety Assessments 
A qualified designee will assess local application site cutaneous reactions by rating the dryness 
and scaling at Baseline, and at all the study visits except the screening visit. The evaluator will 
determine the score for each of these variables by direct evaluation. The definitions of grades 
provided in Table 4 will be applied to these evaluations. The Cutaneous Safety Assessment of 
dryness and scaling will be made by the investigator at the time of the visit. 
Table 4:     Cutaneous Safety Assessment Scale 
 
 
 
Grade 
Description 
Dryness 
0 – None 
No dryness 
1 – Mild 
Slight but definite dryness 
2 – Moderate 
Moderate dryness 
3 – Severe 
Marked dryness and/or cracking 
Scaling 
0 – None 
No scaling 
1 – Mild 
Barely perceptible scaling 
2 – Moderate 
Obvious but not profuse scaling 
3 – Severe 
Heavy scale production and/or peeling 
 
Application site reactions (dryness and scaling) are not to be recorded as adverse events unless 
they result in either: 
• The temporary discontinuation of the study product. 
• The discontinuation of the patient from the study. 
• The use of a new concomitant medication in order to treat this event. 
Any other application site reaction not listed above (such as pain) should be recorded as adverse 
events in the source document and eCRFs. 
15.2. 
Local Tolerability Assessments 
A qualified designee will assess local application site tolerability by rating the itching and 
burning/stinging at Baseline, and at all the study visits except the screening visit. The evaluator 
will determine the score for each of these variables by asking the patient to grade their experience 
over the past 24 hours. The definitions of grades provided in Table 5 will be applied to these 
evaluations. The Local Tolerability Assessment evaluations of itching and burning/stinging will 
be made by the investigator at the time of the visit. 


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Table 5: Local Tolerability Assessment Scale 
 
 
 
Grade 
Description 
Itching 
0 – None 
No itching 
1 – Mild 
Slight itching, not really bothersome 
2 – Moderate 
Definite itching that is somewhat bothersome 
3 – Severe 
Intense itching that may interrupt daily activities and/or sleep 
Burning/Stinging 
0 – None 
No burning/stinging 
1 – Mild 
Slight burning/stinging sensation; not really bothersome 
2 – Moderate 
Definite warm, burning/stinging sensation that is somewhat bothersome 
3 – Severe 
Hot burning sensation that causes definite discomfort and may interrupt daily activities or 
sleep 
 
Application site reactions (itching and burning/stinging) are not to be recorded as adverse events 
unless they result in either: 
• The temporary discontinuation of the study product. 
• The discontinuation of the patient from the study. 
• The use of a new concomitant medication in order to treat this event. 
Any other application site reaction not listed above (such as pain) should be recorded as adverse 
events in the source document and eCRFs. 


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16. 
ADVERSE EVENTS 
16.1. 
Departure from the Protocol for Individual Patients 
When an emergency occurs requiring a departure from the protocol for a patient, departure will be 
only for that patient. In such circumstances, the investigator or other physician in attendance will 
contact the Medical Monitor or the Sponsor by telephone and follow up with a written description 
as soon as possible.  The overseeing IRB should also be notified. 
16.2. 
Definitions 
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a 
medicinal product and which does not necessarily have to have a causal relationship with this 
treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or 
disease temporally associated with the use of a medicinal product, whether or not considered 
related to this medicinal product. 
A serious adverse event (SAE) is an adverse event that results in any of the following outcomes: 
• Death 
• Life-threatening event (i.e., the patient was, in the opinion of the investigator, at immediate 
risk of death from the event as it occurred. It does not include an event that, had it occurred 
in a more severe form, might have caused death 
• Requires in-patient hospitalization or prolongs hospitalization 
• A persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions 
• Congenital anomaly/birth defect 
• Other adverse events that may be considered serious based upon appropriate medical 
judgment, may jeopardize the patient and may require medical or surgical intervention to 
prevent one of the outcomes listed above. 
Immediately Reportable Adverse Events (IRAE) is any serious AE or any AE that necessitates 
discontinuation of study product, including pregnancy. 
Unexpected Adverse Event is any adverse drug experience, the specificity or severity of which is 
not consistent with the current approved product labeling (package insert) for the study product, 
the Investigator’s Brochure, or as described in the clinical protocol and consent materials. 
Intensity of Adverse Events are the maximum intensity of an AE during a day should be recorded 
on the eCRF. If the intensity of an AE changes over a number of days, then separate entries should 
be made having distinct onset dates for the changes in severity. 
• Mild - AEs are usually transient, requiring no special treatment, and do not interfere with 
patient’s daily activities. 
• Moderate - AEs typically introduce a low level of inconvenience or concern to the patient 
and may interfere with daily activities but are usually ameliorated by simple therapeutic 
measures. 
• Severe - AEs interrupt a patient’s usual daily activity and traditionally require systemic 
drug therapy or other treatment. 


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16.3. 
Causal Relationship to Study product 
The following criteria should be used in assessing the apparent causal relationship of an AE to 
study product: 
Definitely - The AE: 
• follows a reasonable temporal sequence from study product administration 
• abates upon discontinuation of the study product (de-challenge) 
• is confirmed by reappearance of the reaction on repeat exposure 
Probably - The AE: 
• follows a reasonable temporal sequence from study product administration 
• abates upon discontinuation of the study product (de-challenge). 
• cannot be reasonably explained by the known characteristics of the patient’s state. 
Possible - The AE: 
• follows a reasonable temporal sequence from study product administration 
• but that could readily be produced by a number of other factors. 
Unlikely - The AE: 
• follows a reasonable temporal sequence from study product administration. 
• could have been produced by either the patient’s clinical state or by study product 
administration. 
Not related - The AE: 
• does not have a reasonable temporal association with the administration of study product 
• has some other obvious explanation for the event. 
16.4. 
Eliciting and Reporting of Adverse Events 
The investigator will periodically assess patients for the occurrence of adverse events. In order to 
avoid bias in eliciting adverse events, the patient or parent/legally authorized representative should 
be asked a non-specific question (e.g., “How have you been feeling since your last visit?”) to assess 
whether any AE has been experienced since the last visit. All adverse events (as defined in 
Section 16.2), either observed by the Investigator or one of his/her medical collaborators, or 
reported by the patient spontaneously, or in response to direct questioning, will be reported and 
documented in the source and the study reporting forms. When reporting an adverse event, the 
Investigator must assign a severity grade to each event and declare an opinion on the relatedness 
of the event to the study product or procedure. Serious or unexpected adverse events must be 
reported to the CRO within 24 hours of when the Investigator first learns of the occurrence of the 
event. 
Adverse events will be documented in the source document and recorded in a timely manner on 
case report forms. Adverse events that are identified at the last assessment visit (or the Early 
Termination Visit) must be recorded on the AE eCRF with the status of the AE noted. 


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Adverse event reporting begins from the signing of informed consent/assent. Study product-
related adverse events should be followed until resolved or 30 days after the final study 
treatment. In any case, serious adverse events that are not resolved or considered to be chronic 
within 30 days of the final study treatment must be followed by the investigator until they become 
resolved or are considered to be chronic (stabilized for at least 30 days). All events that are ongoing 
at this time will be recorded as ongoing on the eCRF. 
16.5. 
Expedited Reporting Responsibilities of the Study Center 
For any serious or unexpected adverse event, the Sponsor or its designee must be notified within 
24 hours of when the Investigator first learns of the occurrence of the event. Expedited reporting 
requirements for serious adverse events are described below. Adequate information must be 
collected with supporting documentation to complete a standard report for submission to Sol-Gel. 
The adverse event term on the AE eCRF and the SAE report should agree exactly. Special 
attention should be given to recording hospitalizations and concomitant medications. 
Patients with unresolved study or product-related adverse event(s) or serious adverse event(s) 
should be followed by the investigator until the events are resolved, events determined to be 
chronic or the patient is lost to follow-up. Resolution means the patient has returned to the Baseline 
state of health, or the investigator does not expect any further improvement or worsening of the 
adverse event. The investigator should continue to report any significant follow-up information 
to the sponsor up to the point that the event has resolved. Any serious adverse event reported by 
the patient to the investigator that occurs within 30 days after the last assessment and are 
determined by the investigator to be reasonably associated with the use of the study product, should 
be reported to the sponsor within 24 hours of when the Investigator first learns of the occurrence 
of the event. 
When reporting a serious adverse event (SAE) the Investigator (or the Study Coordinator) will 
promptly report any serious adverse event or pregnancy to the Sponsor or its designee by telephone 
email, immediately after the investigator becomes aware of the event. An SAE form should be 
completed and sent by fax, email, or overnight courier to the Sponsor or its designee within 24 
hours of knowledge of the event by the site. In many cases, only preliminary information will be 
available. Appropriate follow up information should be sought (hospital discharge summaries, 
operative reports etc.) and a follow up SAE report form submitted. A designation of causality 
from the study product should always be included with a follow up report. Assess and report the 
causality of the event. 
16.6. 
Submitting an Expedited Safety Report to the IRB 
Once all supporting documentation is received for the reported event, the Medical Monitor, in 
conjunction with Sol-Gel, will determine if the safety report is eligible for expedited review. When 
expedited safety reporting to regulatory authorities is indeed required, the Investigator should 
review and update any newly available materials at once. Follow-up queries may be sent to the 
study center to further clarify the event. 


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The Sponsor, or its designee, is responsible for submitting reports of serious, unexpected related 
AEs to regulatory authorities on an expedited basis, according to the ICH E2A Guideline and to 
other regulatory authorities according to national and local regulations as required. The Sponsor, 
or its designee, is responsible for prompt submission to the IRB or EC of any expedited SAE 
reports submitted to regulatory authorities. All investigators participating in ongoing clinical 
studies will receive copies of the SAE reports submitted on an expedited basis to regulatory 
authorities 
16.7. 
SAE & AEs Requiring Discontinuation of Study Drug, including Pregnancies 
ANY SAE, WHICH OCCURS AFTER A PATIENT HAS ENTERED THE STUDY, WHETHER 
OR NOT RELATED TO STUDY PRODUCT, MUST BE REPORTED TO THE SPONSOR OR 
ITS DESIGNEE IMMEDIATELY (WITHIN 24 HOURS) VIA TELEPHONE, EMAIL OR 
FACSIMILE. IF INITIALLY REPORTED VIA TELEPHONE, THIS MUST BE FOLLOWED-
UP BY A FACSIMILE OR EMAIL OF THE WRITTEN SAE REPORT WITHIN 24 HOURS 
OF THE CALL TO THE SPONSOR OR ITS DESIGNEE. 
Non-serious events that require discontinuation of study product (including laboratory 
abnormalities) should be reported to the Sponsor or its designee immediately and within 1 working 
day. 
Patients who discontinue due to experiencing study product-related adverse events should be 
followed clinically until their health has returned to baseline status, or until all parameters have 
returned to normal. It is expected that the investigator will provide or arrange appropriate 
supportive care for the patient. 
A patient who experiences a severe adverse event related to study product will be discontinued 
from the study. Please see SAE and Pregnancy Form Report Instructions for safety reporting 
instructions. 
16.8. 
Pregnancy 
At the time, Principal Investigator or site personnel becomes aware that a study patient became 
pregnant following study participation, the Principal Investigator or designee will report the 
pregnancy immediately by phone and/or by faxing a completed Pregnancy Report to the Sponsor 
or its designee within one working day of being notified of the pregnancy report. 
The report will include the following elements: 
• Patient (mother’s) coded study identifier; 
• Date of patient’s last menstrual period; 
• Total accumulated dose of study treatment administered to date; 
• Date of study product administration. 
The investigator will follow the patient until completion of the pregnancy and must assess the 
outcome in the shortest possible time but not more than 30 days within completion of the 
pregnancy. 
Upon delivery, miscarriage or abortion, the Principal Investigator or designee must forward a 
follow-up Pregnancy Report with any relevant information on the present condition of the fetus to 
the Sponsor or its designee, including: 


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• Mother’s coded study identifier(s); 
• Gestational age at delivery, miscarriage or abortion; 
• Birth weight, gender, length and head circumference, if available; 
• Apgar scores recorded after birth, if available; 
• Any abnormalities. 
If the outcome of the pregnancy meets the criteria for immediate classification of an SAE (e.g., 
spontaneous or therapeutic abortion [any congenital anomaly detected in an aborted fetus is to be 
documented], stillbirth, neonatal death, or congenital anomaly), the investigator will report the 
event by phone and by faxing a completed SAE report form to the Sponsor or its designee within 
one working day of being notified of the pregnancy report. 
If the trial is completed before the outcome of the pregnancy is known, the Sponsor or its designee 
will assume the responsibility for following up on the pregnancy. The Sponsor or its designee will 
contact the Investigator or Study coordinator on or around the potential expected date of delivery 
to follow-up on the outcome of pregnancy and will also check on the status of the infant 8 weeks 
post-delivery. Upon awareness of the pregnancy outcome and known status of the infant following 
8 weeks of delivery, the investigator will complete the applicable pregnancy report forms and fax 
to the Sponsor or its designee within 1 day of being notified. 
16.9. 
Post Study Adverse Events 
16.9.1. 
Non-serious Adverse Events 
Adverse events that are identified at the last assessment visit (or the Early Termination Visit) must 
be recorded on the AE eCRF with the status of the AE noted. 
16.9.2. 
Serious Adverse Events 
Serious adverse events that are identified on the last assessment visit (or the Early Termination 
Visit) must be recorded on the AE eCRF page and reported to Sol-Gel according to the procedures 
outlined above. Patients with unresolved previously reported serious adverse events, or any new 
serious adverse events identified on the last assessment visit, should be followed by the 
investigator until the events are resolved, or the patient is lost to follow-up. Resolution means the 
patient has returned to the baseline state of health, or the investigator does not expect any further 
improvement or worsening of the adverse event. The investigator should continue to report any 
significant follow-up information to Sol-Gel up to the point that the event has resolved. Any 
serious adverse event reported by the patient to the investigator that occurs after the last assessment 
and are determined by the investigator to be reasonably associated with the use of the study 
product, should be reported to Sol-Gel. 


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17. 
STUDY PRODUCTS / CLINICAL SUPPLIES 
17.1. 
Method of Treatment Assignment 
All eligible patients who complete the treatment phase of Phase 3 Study SGT-54-01 or 
Study SGT-54-02 within the Week 12 window and without protocol violation of missing visits 
(i.e., missing more than one of Visits 3, 4 or 5) will be offered to continue to this open-label, 
long- term safety study for up to 40 weeks. New patients, who were not previously enrolled in 
Study SGT-54-01 or Study SGT-54-02 will be enrolled to this open-label, long- term safety study 
for up to 52 weeks. During the study, patients will attend monthly visits. At Baseline, Visit 2, after 
satisfying all the Entry Criteria or Inclusion/Exclusion Criteria and after approval of the 
investigator, the patient will be assigned study product by the IWRS. Study medication will be 
marked in four (4)-digit pump number XXXX. At every visit, a new pump will be supplied to the 
patient. 
17.2. 
Formulation 
Study Product name: 
Encapsulated Benzoyl Peroxide Cream, 5% 
Sponsor name: 
S5G4T-1 
Active ingredients: 
benzoyl peroxide 
Inactive ingredients: 
see list below 
The inactive ingredients include: silicon dioxide, cetrimonium chloride, polyquaternium-7, lactic 
acid, hydrochloric acid, polyoxyl 100 stearate, cetyl alcohol, cyclomethicone 5, glyceryl 
monostearate, citric acid anhydrous, sodium hydroxide, edetate disodium, glycerin, phenoxy 
ethanol and water. 
17.3. 
Study Products Packaging and Labeling 
The study medication intended to be used will be stored together. The pump will carry a yellow, 
two-part label with a perforation. The tear-off section of the label will be attached to the study 
product dispensing log at the time the study product is dispensed. The label has spaces to enter 
the patient’s initials and date of assignment and shows: 
• Protocol number 
• Patient number 
• Pump number 
• Patient Initials 
• Dispense Date 
• Dispenser Initials 
• Contains: one (1) pump of Encapsulated Benzoyl Peroxide (E-BPO) Cream, 5%, 55g. 
• Directions for use: Apply as directed, for topical use only. 
• Storage conditions “Store at Room Temperature 20 to 25°C (68 to 77°F). Excursions 
permitted between 15 to 30°C (59 to 86°F).” 
• Keep container tightly closed. 
• Do not freeze and do not refrigerate 


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• Keep out of reach of children 
• Study product warning. “Caution: New Drug - Limited by Federal (or United States) Law 
to Investigational Use” 
• Sponsor information 
17.4. 
Preparation, Dispensing and Storage Instructions 
The study product must be dispensed only to study patients and only at study sites specified on the 
form FDA 1572 by authorized personnel as required by applicable regulations and guidelines. 
Study product will be dispensed according to Investigator Global Assessment at: Baseline, 
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 for patients entering from study SGT-54-01 or study 
SGT-54-02 and for new patients at: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 
48. Study product will be returned at: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 for patients 
entering from study SGT-54-01 or study SGT-54-02 and for new patients at: Weeks 4, 8, 12, 16, 
20, 24, 28, 32, 36,40,44, 48 and 52. Study product weight will be documented) prior to dispensing 
and after return of each pump per flow chart (Section 13.9 and Section 13.10). 
Each Patient will be instructed on the importance of returning his or her study product at each 
designated visit. If a Patient does not return his or her study product, he or she will be instructed 
to return it at the next visit. 
The study coordinator will question the patient on history of study product use since the last visit 
and will record any missed doses (as recorded on the patient diary) in both the source documents 
and the appropriate eCRF. A patient who deviates significantly from the prescribed dosage will 
be counseled. 
Study product should be stored at room temperature 20 to 25°C (68 to 77°F). Excursions permitted 
between 15 to 30°C (59 to 86°F). Do not freeze or refrigerate the product. 
17.5. 
Dosing Instructions 
Topical application of study product will be made to the face once daily at approximately the same 
time of the day, for the study period. Study product will be applied as a thin coating that is gently 
rubbed in to the skin. 
Each patient will receive both verbal and written instructions (see Appendix 1) as to the proper 
dosing and study product application techniques. 
Patients will be instructed to apply the study product, once a day after cleansing. No time interval 
between dosing and meals or any other activity is specified. 


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Patients will cleanse their face with the sponsor provided or approved cleanser using only the 
hands and pat dry with a soft clean towel. Patients will use a “pea-size” amount for each area of 
the face (chin, left cheek, right cheek, nose, left forehead and right forehead). The patient should 
apply the study cream on each area of the face as evenly as possible and gently rub the cream into 
the skin. Each pea-size amount should be used to evenly cover the following parts on the patient’s 
face: chin, left cheek, right cheek, nose, left forehead and right forehead excluding the mouth, eyes 
and lips. The patient should wash his/her hands after application but should not wash face at least 
2 hours after study product application. Patients should wait at least 30 minutes before applying 
moisturizer/sunscreen after application of study product to the face. During the trial that 
investigators remind patients to avoid exposure to sunlight and sunlamps and to wear sunscreen 
when sun exposure cannot be avoided. 
The patients will be instructed to continue using the same provided or approved facial cleanser and 
not to change products during the study. At each visit, patients are to be asked if they have changed 
their cleansing routine. The provided or approved cleanser and moisturizer/sunscreen should be 
applied according to the directions on the pump. Facial makeup (non-medicated) may be applied 
according to the patient’s normal daily routine (but not prior to 30 minutes after study product 
application); however, patients should be instructed not to apply the moisturizer or sunscreen or 
combination of them or wear make-up during study visits as it may interfere with the evaluator’s 
assessments. No other products should be used on the face. 
The patient will be provided a set of instructions (Appendix 1) that includes study reminders and 
restrictions as described in this protocol. Patients will be instructed to bring the study product to 
each visit and to not apply study product one hour prior to the study visit. Patients should be 
instructed to store the study product at room temperature, not in the refrigerator or freezer and 
informed that the test article may bleach colored fabric. 
17.6. 
Study Product Accountability and Study Records at Sites 
Upon receipt of the clinical supplies, the study staff will conduct a complete inventory of study 
products and assume responsibility for their storage and dispensing. In accordance with federal 
regulations, the Investigators must agree to keep all study products in a secure, temperature-
controlled location with restricted access. 
All supplies sent to the Investigators will be accounted for and in no case used in any unauthorized 
manner. All used and unused study product will be appropriately inventoried by the clinical site 
and verified by the clinical monitor. 
Study product will be weighed before dispensing and upon return and weights will be recorded on 
the appropriate source document and eCRF. 
17.7. 
Return and Destruction of Study Product Supplies 
Upon completion or termination of the study, all remaining pumps must be appropriately 
inventoried and returned to Sponsor or designee by a traceable method. All missing pumps of 
study products must be explained on the completed Clinical Supplies Return Form. The study site 
must keep a copy of the Clinical Supplies Return Form in the study file. 
17.8. 
Additional Supplies Provided by Sponsor 
• Regulatory study file system (Investigator Binder) 
• Cleanser 


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• Moisturizer/sunscreen 
 
18. 
STATISTICAL CONSIDERATIONS 
18.1. 
General Statistical Methodology 
All statistical processing will be performed using SAS® version 9.3 or later unless otherwise stated. 
Data will be summarized using descriptive statistics. No inferential testing or imputations for 
missing data will be performed.  No interim analyses are planned for the co-primary variables. 
For categorical parameters, the number and percentage of patients in each category will be 
presented. For continuous parameters, descriptive statistics will include n (number of patients), 
mean, standard deviation, median, minimum and maximum. 
18.2. 
Populations Analyzed 
All analyses will be performed using the Safety Population of the study. Part of this population 
will be referred as the extension safety population, and part as a new enrolled safety population. 
All patients who receive at least one confirmed dose of S5G4T-1 (in either Study SGT-54-01 or 
Study SGT-54-02, and in this study or for new patients in this study) and have at least one 
assessment will be included in the Safety Population. 
The number of patients included in the Safety Population will be summarized. 
18.3. 
Analysis of Efficacy 
This study is not intended to assess efficacy, but rather the IGA is included to determine the need 
for treatment and subsequent re-treatment after treatment course (in either Study SGT-54-01 or 
Study SGT-54-02 or for new patients not previously enrolled in Study SGT-54-01   or 
Study SGT-54-02) and any subsequent 4-week courses, if applicable. Certain efficacy data and 
endpoints will, however, be summarized. 
Descriptive statistics will be used to summarize the assessment of efficacy. IGA scores will be 
summarized at Baseline Visit of Study SGT-54-01 or Study SGT-54-02 or at the Screening visit 
of SGT-54-07 for those patients not previously enrolled in Study SGT-54-01 or Study SGT-54-02, 
and entry into the study (SGT-54-07) and every 4 weeks through end of the study. The number 
and percentage of patients who achieve treatment success at the scheduled study visits will be 
tabulated. 
The number of retreatments is defined as the number of clinical confirmations of the condition for 
which the subject was initially treated after the first treatment period with S5G4T-1. For rollover 
subjects previously treated with Vehicle Cream, this is the number after the initial treatment in 
Study SGT-54-07. For rollover subjects previously treated with S5G4T-1, this is the number of 
treatments in Study SGT-54-07 following the cessation of the treatment which began in Study 
SGT-54-01 or Study SGT-54-02. 


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The number of treatment free days until the first retreatment (relapse) will be calculated and 
analyzed. For rollover subjects previously treated with Vehicle Cream, the number of treatment 
free days will be the number of days between the end of the initial treatment in study SGT-54-07 
and the start of the next treatment in study SGT-54-07 if one should be needed or the end of the 
subject’s participation in study SGT-54-07. For rollover subjects previously treated with S5G4T1, 
the number of treatment free days will be the of days between the end of the initial treatment that 
began in Study SGT-54-01 or Study SGT-54-02 and the start of the next treatment in study SGT- 
54-07 if one should be needed or the end of the subject’s participation in the study SGT-54-07. 
Descriptive statistics for retreatment rates will be presented. The time (number of days) to relapse 
will be analyzed using the Kaplan–Meier method. The median time to relapse will be calculated 
in addition to other appropriate descriptive statistics. Patients who discontinue study SGT-54-07 
without relapse will considered censored in the Kaplan–Meier analysis. 
18.4. 
Safety Evaluation 
Safety will be evaluated by tabulations of adverse events (AEs), Cutaneous Safety Assessments 
for dryness and scaling, Local Tolerability Assessment for itching and burning and assessments 
for erythema and telangiectasia will be presented with descriptive statistics at Baseline and at the 
scheduled study visits. Frequencies and percentages for each outcome category will be included 
in these statistics. Safety data will be presented for patients in the Safety Population with 
tabulations for the following periods 12 to 28 weeks, > 28 to 52 weeks and > 52 weeks to the end 
of the study, as well as an overall for all periods. 
18.4.1. 
Exposure and Compliance 
The extent of exposure to study product in each treatment group will be summarized by total 
number of days of exposure to S5G4T-1, total number of applications and number of missed 
applications. No formal evaluations of compliance are planned. 
18.4.2. 
Adverse Events 
All adverse events occurring during the study will be recorded and classified on the basis of 
MedDRA terminology. Descriptions of AEs will include the date of onset, the date the AE ended, 
the severity of the AE, the relationship to study product, the action taken regarding study product 
usage, the action taken to treat the AE, and the outcome. All reported treatment-emergent AEs 
(TEAEs) will be summarized by the number of patients reporting AEs, system organ class, 
severity, seriousness, and relationship to study product. TEAEs are those AEs with an onset on or 
after the date of the first study product application. 
Adverse events will be summarized by period (and total) and by severity. Each patient will be 
counted only once within a system organ class or a preferred term by using the adverse events with 
the highest severity within each category. 
Adverse events will be summarized by period (and total) and relationship to study product. Each 
patient will be counted only once within a system organ class or a preferred term by using the 
adverse events with the greatest relationship within each category. 
All information pertaining to AEs noted during the study will be listed by patient, detailing 
verbatim given by the investigator, preferred term, system organ class, start date, stop date, 
severity, actions taken, and drug relatedness. The AE onset will also be shown relative (in number 
of days) to the day of initial dose of the study product. 


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Serious adverse events (SAEs) will be tabulated. 
In addition, a list of patients who discontinued from the study and a list of patients who experienced 
SAEs will also be provided. 
TEAEs will be summarized by the number of patients reporting a TEAE, system organ class, 
preferred term, severity, relationship to study product (causality) and seriousness. When 
summarizing AEs by severity and relationship, each patient will be counted once within a system 
organ class or a preferred term by using the event with the highest severity and greatest relationship 
within each classification. 
18.4.3. 
Vital Sign Measurements 
Vital signs, as recorded during the brief physical examination, as well as changes from Baseline 
in vital sign measurements will be summarized with descriptive statistics for each treatment group 
at all applicable study visits. 
18.4.4. 
Exploratory Endpoint 
The mean change in RosaQoL subscale scores from Baseline will be summarized for each 
treatment group at all applicable study visits. 


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19. 
ADMINISTRATIVE CONSIDERATIONS 
19.1. 
Protocol Compliance 
The IRB-approved protocol must be followed except in the case of a change that is intended to 
eliminate an immediate risk to patients. All protocol deviations must be documented in the source 
documents and in the comment CRFs. 
19.2. 
Protocol Revisions 
Sponsor or designee must prepare all protocol revisions. All protocol amendments must receive 
IRB approval prior to implementation. All administrative letters must be submitted to the IRB for 
their information. Copies of all correspondence with the IRB regarding this study must be sent to 
Sponsor or CRO designee. New or altered consent forms required by the IRB due to a protocol 
revision must be signed by all patients currently enrolled in the study and must be used for any 
subsequent patient enrollment. 
19.3. 
Protocol Monitoring 
Representatives of Sponsor must be allowed to visit all study sites, to review study records and to 
directly compare them with source documents (including, but not limited to patient and hospital 
records), to discuss the study conduct with the investigator and study staff; and to verify that the 
investigator, study staff and facilities remain acceptable for the conduct of the study. 
Representatives of government regulatory authorities (i.e., FDA) may also evaluate the study 
records, source documents, investigator, study staff, and facilities. 
The investigator must immediately notify Sponsor of any audits by any regulatory agency, and 
must promptly provide copies of any audit reports. 
19.4. 
Required Study Documents 
The investigator must provide the following documents to Sponsor or CRO designee before any 
patients are enrolled and/or study product may be shipped to the study site: 
• The signed INVESTIGATOR PROTOCOL ACKNOWLEDGEMENT page from the 
Sponsor and IRB approved protocol. 
• Documentation of IRB approval of the protocol, informed consent form, any other written 
information provided to patients and any recruitment advertisements. 
• A copy of the IRB approved informed consent form 
• A current IRB assurance number and/or a membership roster. 
• A completed, signed and dated Form FDA 1572. 
• The appropriate financial disclosure documentation. 
• A current signed and dated curriculum vitae and a copy of the current medical license for 
the investigator and sub-investigators listed on the Form FDA 1572. 
• The signed agreement between the investigator and Sponsor, or designee, and related 
financial information for the study (this file is confidential and currently FDA has no 
authority to review this information.  Keep this information in a separate file). 


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19.5. 
Electronic Case Report Forms (eCRF)/Source Documents 
Electronic case report forms (eCRFs) called also electronic data capture (EDC) system, will be 
used for recording all data from source documents for each patient. Source documents are the 
point of first entry for all data collected. Whenever possible, an original recording of an 
observation should be retained as source document. 
The investigator will ensure that the eCRFs are properly and completely filled in. The eCRFs must 
be completed for all patients who have signed an informed consent form. The eCRFs will be 
monitored against source documents. If data in the eCRF is not duplicated in a source document, 
a source document should be created and maintained by the site to capture that information. Source 
documentation for patients includes but is not limited to the physician’s patient records and diaries. 
All source documents will be maintained at the study site. 
The Investigator or delegate may enter corrections in the eCRFs, which will create an auditable 
history of all changes and by whom they were made. The final eCRF will be approved by the 
Investigator by electronic signature. 
19.6. 
Reports to the IRB/Ethics Committee (EC) 
Before study initiation, the investigator must have written and dated approval from the IRB for the 
protocol, consent form, patient recruitment materials /process (e.g., advertisements), and any other 
written information to be provided to patient. The investigator should also provide the IRB with 
a copy of the Investigator’s Brochure and/or package insert. The investigator should provide the 
IRB with reports, updates, and other information (e.g., safety updates, protocol amendments, and 
administrative letters) according to regulatory requirements or Institution procedures. 
19.7. 
Quality Assurance Audits 
Representatives from Sponsor and/or a third party selected by Sponsor may conduct a quality 
assurance audit of this study. During the audit, the Investigator must provide the auditor with 
direct access to all relevant documents and discuss any findings with the auditor. 
In the event of an inspection by the Food and Drug Administration or other regulatory authorities, 
the Investigator will notify the Sponsor /CRO as soon as possible of such notice and must give the 
inspector direct access to relevant documents and discuss any findings with the inspector. 
19.8. 
Records Retention 
The investigator must maintain records of the study product disposition, copies of the case report 
forms and all source documents for the maximum period of five years after NDA approval as 
required by Sponsor. The investigator must contact Sponsor prior to destroying any records 
associated with this study. 
If the location of the study files changes from the address noted on the FDA Form 1572, written 
notification of the new location must be given to Sponsor. If the investigator withdraws from 
participation in the study the records shall be transferred to a mutually agreed-to designee. Written 
notification of such a transfer must be given to Sponsor. 


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20. 
REFERENCES 
Breneman D., Savin R., VandePol C., Vamvakias G., Levy S., Leyden J. Double-blind, 
randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin topical 
gel in the treatment of patients with moderate to severe rosacea. Int. J of Derm. 2004; 43(5):381-
387. 
Fyrand 0, Jakobsen HB. Water-based versus alcohol-based benzoyl peroxide preparations in the 
treatment of acne vulgaris. Dermatolgica 1986 172:263-267. 
Jansen T. and Plewig G. Rosacea: classification and treatment. JR Soc Med. 1997; 90(3):144-150. 
Leyden JJ, Hickman JG, Jarratt MT, Stewart DM, Levy SF. The efficacy and safety of a 
combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide alone and 
a benzoyl peroxide/erythromycin combination product. J Cutan Med Surg. 2001. 5:37-42. 
McDonnell JK and Tomecki KJ. Rosacea: an update. Clev Clinic J Med. 2000; 67(8):587-590. 
Montes LF., Cordero AA., Kriner J., Loder J., Flanagan AD. Topical treatment of acne rosacea 
with benzoyl peroxide acetone gel. Cutis 1983; 32(2):185-190. 
Thiboutot DM, Weiss J, Bucko A, Eichenfield L, Jones T, Clark S, Liu Y, Graeber M, Kang S. 
Adapalen-BPO Study Group. Adapalene-benzoyl peroxide, a fixed-dose combination for the 
treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. 
J Am Acad Dermatol. 2007. 57:791-799. 
Tschen EH, Katz HI, Jones TM, Monroe EW, Kraus SJ, Connolly MA, Levy SF. A combination 
benzoyl peroxide and clindamycin topical gel compared with benzoyl peroxide, clindamycin 
phosphate, and vehicle in the treatment of acne vulgaris. Cutis.  2001. 67:165-169. 
Weiss JW, Shavin J, Davis M. Preliminary results of a nonrandomized, multicenter, open-label 
study of patient satisfaction after treatment with combination benzoyl peroxide/clindamycin 
topical gel for mild to moderate acne. Clin Ther. 2002.  24:1706-1717. 


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APPENDIX 1: 
PATIENT INSTRUCTION SHEET 
Please follow these instructions carefully. Contact the study staff at the telephone number noted 
below if you have any questions about the study: 
 
 
Contact: 
At: 
 
 
STUDY PRODUCT APPLICATION: 
• At first application, priming is required. 
• Apply the study cream once a day every day during the study period unless instructed 
otherwise by the study team. The study doctor will discuss with you when you should apply 
the study cream if your skin is clear. 
• Wash your face gently with the mild cleanser provided by the doctor or by study approved 
cleanser for this study from the sponsor and water. Rinse thoroughly and gently pat dry. 
• A thin coating of study cream should be applied once daily (preferably at the same time 
each day) to the entire face during the study period. 
• Apply one gentle pump application of study cream from pump onto the tip of your finger 
the size of a pea for each area of the face (chin, left cheek, right cheek, nose, left forehead 
and right forehead), as instructed at your first study visit. 
• Apply the study cream on each area of the face as evenly as possible and gently rub into 
the skin. Each pea-size amount should be used to evenly cover the following parts on your 
face: chin, left cheek, right cheek, nose, left forehead and right forehead excluding the 
mouth, eyes and lips. 
• Do NOT treat specific lesions but rather the entire face. 
• Be sure to wash your hands after you apply the study cream. But do not wash your face 
for at least two hours after you apply study cream. 
• Wait for at least 30 minutes before applying the study provided or approved 
moisturizer/sunscreen. 
• If applicable, wait at least 30 minutes before applying only non-medicated make-up. 
 
ADDITIONAL REMINDERS: 
• Store study cream at Room Temperature 20 to 25°C (68 to 77°F). Excursions permitted 
between 15 to 30°C (59 to 86°F). Do not freeze, refrigerate or expose to extreme 
temperature.” 
• Avoid contact with the eyes, inside the nose, mouth and all mucous membranes. 
• Caution: This product contains benzoyl peroxide which can bleach hair or colored fabric. 
• THE STUDY CREAMTSHOULD BE USED ONLY BY THE PERSON FOR WHOM IT 
WAS PRESCRIBED and it should be kept out of the reach of children or others of limited 
capacity to read or understand. 


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• Pumps of study cream must be returned to the study facility, even if they are empty. 
• If you miss any doses, at your next visit inform the study doctor of the date(s) of the missed 
dose(s). Please record all doses on the Diary Card provided to you; indicate reason for any 
missed dose on the Diary Card. 
• If you use a moisturizer and/or sunscreen, you must use the one provided or approved by 
the doctor for this study. 
• On the day of your study visit, do not apply moisturizer/sunscreen, or make-up. 
• You must not use any other treatment for your rosacea while you are participating in this 
study. 
• Avoid unnecessary sun exposure and tanning booths. When sun exposure cannot be 
avoided, use the approved moisturizer/sunscreen and wear a wide-brimmed hat. 
It is important that you inform the study site about any medications (i.e., prescriptions, over-the-
counter medications, street drugs, or herbal medications) that you have taken during the study. 
Bring this sheet, your updated Diary Card, and your study cream pump with you to every study 
visit. 
 
 
STUDY VISIT SCHEDULE for patient entered from study SGT-54-01 or study SGT-54-02: 
 
VISIT 2: Baseline, Day 1 
Date: 
Time: 
VISIT 5: Week 12, Day 85 
Date: 
Time: 
VISIT 9: Week 28, Day 197 
Date: 
Time: 
VISIT 3: Week 4, Day 29 
Date: 
Time: 
VISIT 6: Week 16, Day 113 
Date: 
Time: 
VISIT 10: Week 32, Day 225 
Date: 
Time: 
VISIT 4: Week 8, Day 57 
Date: 
Time: 
VISIT 7: Week 20, Day 141 
Date: 
Time: 
VISIT 11: Week 36, Day 253 
(if applicable) 
Date: 
Time: 
VISIT 8: Week 24, Day 169 
Date: 
Time: 
VISIT 12: Week 40, Day 281 
(if applicable) 
Date: 
Time: 
 
 
 
 
 
STUDY VISIT SCHEDULE for new patient: 


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VISIT 2: Baseline, Day 1 
Date: 
Time: 
VISIT 7: Week 20, Day 141 
Date: 
Time: 
VISIT 12: Week 40, Day 281 
(if applicable) 
Date: 
Time: 
VISIT 3: Week 4, Day 29 
Date: 
Time: 
VISIT 8: Week 24, Day 169 
Date: 
Time: 
VISIT 13: Week 44, Day 309 
(if applicable) 
Date: 
Time: 
VISIT 4: Week 8, Day 57 
Date: 
Time: 
VISIT 9: Week 28, Day 197 
Date: 
Time: 
VISIT 14: Week 48, Day 337 
(if applicable) 
Date: 
Time: 
VISIT 5: Week 12, Day 85 
Date: 
Time: 
VISIT 10: Week 32, Day 225 
(if applicable) 
Date: 
Time: 
VISIT 15: Week 52, Day 365 
(if applicable) 
Date: 
Time: 
VISIT 6: Week 16, Day 
113 
Date: 
Time: 
VISIT 11: Week 36, Day 253 
(if applicable) 
Date: 
Time: 
 
 
 
Thank you for following these instructions. 


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APPENDIX 2: ROSACEA QUALITY OF LIFE QUESTIONNAIRE 
(ROSAQOL) 

SAP_001.pdf: 
Statistical Analysis Plan 
Sol-Gel Technologies Ltd. SGT-54-07 
Version: 1.0 
Date: 18 NOV 2019 
TOOL.AN.10-01.01 Statistical Analysis Plan Template          
 Page 1 of 131 
CONFIDENTIAL 
STATISTICAL ANALYSIS PLAN 
Protocol Number: 
SGT-54-07 
Study Title: 
A Multi-Center, Open-Label, Long-Term 
Safety Study of S5G4T-1 to Evaluate the 
Safety of S5G4T-1 in Papulopustular 
Rosacea Patients 
Development Phase of Study: 
3 
Sponsor:  
Sol-Gel Technologies Ltd. 
Sponsor Contact: 
 
Statistical Analysis Plan based on Protocol Version: 
4.0 
Statistical Analysis Plan Date: 
18NOV2019 
Statistical Analysis Plan Version: 
V1.0 
NCT #NCT03564145




 
Statistical Analysis Plan 
Sol-Gel Technologies Ltd. SGT-54-07 
Version: 1.0 
Date: 18 NOV 2019 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 3 of 131 
CONFIDENTIAL 
SAP Change History 
Version Date 
Summary of Changes  
Author 
1 
18NOV2019 Original document 
 
 
 


 
Statistical Analysis Plan 
Sol-Gel Technologies Ltd. SGT-54-07 
Version: 1.0 
Date: 18 NOV 2019 
 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 4 of 131 
CONFIDENTIAL 
TABLE OF CONTENTS 
1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ....................................6 
2. 
PREFACE ..............................................................................................................................7 
3. 
RESPONSIBILITIES ...........................................................................................................7 
4. 
INTRODUCTION .................................................................................................................7 
5. 
STUDY OBJECTIVES .........................................................................................................9 
6. 
STUDY DESIGN .................................................................................................................10 
6.1 Overall Study Design ....................................................................................................10 
6.1.1 
Schedule of Visits and Assessments ...............................................................11 
6.1.2 
Method of Assigning Subjects to Treatment Groups ......................................11 
6.1.3 
Blinding ...........................................................................................................11 
7. 
EFFICACY AND SAFETY ENDPOINTS .......................................................................12 
7.1 Efficacy Endpoints ........................................................................................................12 
7.2 Safety Endpoints ...........................................................................................................12 
8. 
STATISTICAL AND ANALYTICAL PLANS ................................................................12 
8.1 General Methodology ...................................................................................................12 
8.1.1 
Statistical Analysis ..........................................................................................13 
8.1.2 
Baseline Definition ..........................................................................................13 
8.1.3 
Visit Windowing .............................................................................................13 
8.1.4 
Adjustments for Covariates .............................................................................16 
8.1.5 
Handling of Dropouts or Missing Data ...........................................................16 
8.1.6 
Interim Analyses and Data Monitoring ...........................................................17 
8.1.7 
Multicenter Studies ..........................................................................................17 
8.1.8 
Multiple Comparisons/Multiplicity .................................................................17 
8.1.9 
Use of an Efficacy Subset of Subjects .............................................................17 
8.1.10 Active-Control Studies Intended to Show Equivalence ..................................17 
8.1.11 Examination of Subgroups ..............................................................................17 
8.2 Disposition of Subjects .................................................................................................17 
8.3 Protocol Deviations .......................................................................................................18 
8.4 Data Sets Analyzed .......................................................................................................18 
8.4.1 
Safety Population ............................................................................................18 


 
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8.5 Demographic and Other Baseline Characteristics ........................................................18 
8.6 Prior and Concomitant Medications .............................................................................19 
8.7 Prior and Concomitant Procedures/Therapies ..............................................................19 
8.8 Analysis of Efficacy ......................................................................................................20 
8.8.1 
IGA ..................................................................................................................20 
8.8.2 
Retreatments ....................................................................................................20 
8.8.2.1 
RosaQoL 21 
8.8.2.2 
Rosacea Erythema and Telangiectasia Assessments ...................22 
8.9 Safety Evaluation ..........................................................................................................22 
8.9.1 
Extent of Exposure ..........................................................................................22 
8.9.2 
Adverse Events ................................................................................................23 
8.9.3 
Clinical Laboratory Evaluation .......................................................................24 
8.9.4 
Other Observations Related to Safety .............................................................24 
8.9.4.1 
Cutaneous Safety Assessments ....................................................24 
8.9.4.2 
Local Tolerability Assessments ...................................................25 
8.9.4.3 
Vital Signs ....................................................................................25 
8.9.4.4 
Physical Examination...................................................................25 
9. 
DETERMINATION OF SAMPLE SIZE .........................................................................25 
10. CHANGES IN THE PLANNED ANALYSES..................................................................25 
11. REFERENCES ....................................................................................................................25 
12. INDEX OF PLANNED TABLES ......................................................................................27 
13. INDEX OF PLANNED LISTINGS ...................................................................................96 
 
 


 
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1. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE(s) 
adverse event(s) 
ATC 
Anatomical Therapeutic Chemical 
BMI 
body mass index 
BPO 
benzoyl peroxide 
C 
Celsius 
cm 
centimeters 
CRF(s) 
case report form(s) 
CI 
confidence interval 
eCRF(s) 
electronic case report form(s) 
E-BPO 
encapsulated benzoyl peroxide 
ET 
early termination 
IGA 
Investigator Global Assessment 
IWRS 
Interactive Web Response System 
kg 
kilograms 
max 
maximum 
min 
minimum 
n 
number of observations 
N 
number of subjects (sample size) 
PI 
Principal Investigator 
QST 
QST Consultations, Ltd. 
RosaQoL 
Rosacea Quality of Life Questionnaire 
SAE(s) 
serious adverse event(s) 
SAP 
Statistical Analysis Plan 
SAS® 
Statistical Analysis System (SAS® Institute Inc., Cary, NC) 
SD 
standard deviation 
SOC 
system organ class 
TEAE(s) 
treatment-emergent adverse event(s) 
WHO 
World Health Organization 


 
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2. PREFACE  
This Statistical Analysis Plan (SAP) describes the statistical analyses as it is foreseen before the 
database is locked. The SAP will serve as a compliment to the study protocol and supersedes it in 
case of differences. In case of major differences between the study protocol and SAP, e.g. 
changes in the analysis related to the primary endpoint, a protocol amendment will be 
considered. The SAP may be updated during the study conduct and will be finalized before the 
database lock. 
The following documents were reviewed in preparation of this SAP: 
• Clinical Study Protocol SGT-54-07 
o Version 1.0 issued on 27JUN2018,  
o Version 2.0 issued on 20AUG2018, 
o Version 3.0 issued on 16SEP2018, 
o Version 4.0 issued on 27NOV2018 
• Case report form (CRF) for SGT-54-07. 
• ICH E9 Guidance on Statistical Principles for Clinical Trials. 
• ICH E3 Structure and Content of Clinical Study Reports (CSRs) 
The reader of this SAP is encouraged to also read the clinical protocol for details on the conduct 
of this study, and the operational aspects of clinical assessments and timing for completing a 
patient in this study. 
3. RESPONSIBILITIES 
The study statistician will be responsible for the statistical analysis planning. QST Consultations, 
Ltd. (QST), a Contract Research Organization selected by Sol-Gel, will be responsible for the 
execution of all statistical programming deliverables. The statistical programming work will be 
supervised by the study statistician. 
4. INTRODUCTION 
S5G4T-1 is an innovative topical formulation containing 5% encapsulated benzoyl peroxide (E-
BPO) that Sol-Gel is developing for the treatment of rosacea. If approved, S5G4T-1 will be the 


 
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first product containing E-BPO for the treatment of rosacea. Sol-Gel believes S5G4T-1 has the 
potential to be as tolerable as, and more effective than, currently marketed rosacea drugs.  
Rosacea is a chronic and recurrent inflammatory dermatological disorder of unknown etiology. 
The disease is common, especially in fair-skinned people of Celtic and northern European 
heritage. The onset of the disorder is usually between the ages of 30 and 50. Early stages of the 
disease affect women more often than men at a ratio of 3 to 1 [3, 5]. Rosacea usually starts as 
flushing and subtle redness on the cheeks, nose, chin or forehead. Alcohol, hot drinks, spicy 
foods, stress, sunlight and extreme heat or cold can trigger the onset of this disease. If left 
untreated, rosacea can slowly worsen over time. As the condition progresses, patients experience 
inflammatory lesions (papules and pustules), vivid erythema and telangiectasia. Patients may 
develop furuncles, cystic nodules, granulomas and tissue hypertrophy, sometimes leading to 
rhinophyma.  
The first report on the treatment of rosacea with benzoyl peroxide (BPO) as a single agent was 
described by in Montes et al. in 1983 [6]. In this limited study, 5% BPO, after 5 to 8 weeks of 
treatment, demonstrated superiority compared to control with respect to papules, pustules and 
erythema but not telangiectasia. The formulation was a basic formulation with BPO dissolved 
and delivered in acetone. Irritation and burning was reported in both groups, most likely due to 
the well-known effects of BPO.  
More recently, Breneman et al. 2004 [1] published the results of a study in collaboration with J. 
Leyden. This study was a double-blind, vehicle-controlled study, using a combination gel 
product of 5% BPO and 1% clindamycin to treat patients having moderate to severe rosacea. The 
most dramatic effect of the BPO/clindamycin treatment was on the reduction of papules and 
pustules. Side effects included the well-known effects of BPO, burning and itching.  
The most prevalent AEs associated with topical BPO were related to local irritation. These 
included dry skin, peeling, burning and erythema. For the published studies, the percentage of 
subjects with dermatological AEs considered possibly related to BPO monotherapy ranged from 
7% [7] to 22% [8]. In studies sponsored by Sol-Gel, the percentage of subjects with 
dermatological AEs associated with E-BPO 7% cream ranged from 0% (Study SGT-03B) to 
37% (Study SGT-04), and the incidence of dermatological AEs associated with lower 
concentrations of E-BPO cream was ≤ 2%. 
Several published studies reported AEs that might be associated with sensitivity of subjects to 
BPO. Leyden et al. 2001 [4] reported that 1 of 164 subjects (0.6%) receiving 5% BPO had an 
allergic reaction, and that allergic reactions occurred for 1.2% of subjects receiving 5% BPO plus 
1% clindamycin and for 3.1% of subjects receiving 5% BPO plus 3% erythromycin. Tschen et 


 
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al. 2001 [8] reported a rash for l of 95 subjects (1%) that received 5% BPO monotherapy. Fyrand 
and Jakobsen 1986 [2] reported that 2 of 49 subjects withdrew from the study due to severe 
dermatitis indicating possible sensitization. Montes et al. 1983 [6] reported hypersensitivity to 
BPO in 4 of 31 subjects receiving 5% BPO acetone gel for rosacea. Weiss et al. 2002 [9] 
reported that 2 of 257 subjects receiving BPO plus clindamycin developed urticaria. In Study 
KGL 5782, 1 subject developed possible delayed contact hypersensitivity to both E-BPO, 2.5%, 
and Proactiv, 2.5%, indicating the hypersensitivity was probably due to BPO not an excipient. 
None of these events that might possibly indicate sensitization were confirmed by patch testing.  
In 2012, Sol-Gel completed a double blind, randomized, dose-ranging Phase 2 trial for S5G4T-1 
involving 92 adult patients at 10 centers in the United States (Study SGT-EBPO1-09: A Multi-
Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of E-BPO Gel, 1% 
and 5%, and Vehicle Gel in the Treatment of Rosacea). The Phase 2 study had the primary 
endpoints: Success in Investigator Global Assessment (IGA) and reduction in the mean 
inflammatory lesion count at Week 12 (End of Study). Safety was evaluated through AE 
reporting and cutaneous safety and local tolerability assessments. Both E-BPO cream, 1% and 
5% applied once daily for 12 weeks had a positive effect on rosacea and were safe and well 
tolerated in this study. No deaths or other SAEs were reported during the study. Study 
medication was withdrawn for 1 subject who applied E-BPO cream, 5% (severe application site 
reaction) and for 2 subjects who applied E-BPO cream, 1% (severe cyst and moderate 
application site dermatitis). None of the subjects had severe dryness, scaling, or pruritus post-
baseline. One subject in the E-BPO cream, 5% group experienced severe stinging and burning 
reported as an AE. 
5. STUDY OBJECTIVES 
The objective of this long-term safety study is to determine the nature, severity and frequency of 
the AE rate and the cutaneous safety and local tolerability assessments of S5G4T-1 when applied 
once daily, if applicable, for up to 52 weeks.  
The safety endpoints to be assessed include the following:  
• The frequency of both local and systemic AEs  
• Investigator cutaneous safety assessment (dryness and scaling) and the local tolerability 
assessment (itching and burning/stinging) at Baseline and all post-baseline study visits.  


 
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6. STUDY DESIGN 
6.1 
Overall Study Design 
Approximately 700 patients will be enrolled at up to 56 sites. All patients in this open-label, 
long-term safety study will be assigned to treatment with S5G4T-1.  
The objective of this study is to determine the long-term safety and tolerability of daily use of 
S5G4T-1 in papulopustular rosacea patients.  
Patients who successfully completed the 12-week treatment period from Study SGT-54-01 or 
Study SGT-54-02 may be offered to continue in the long-term safety, open-label extension study 
(Study SGT-54-07) for up to an additional 40 weeks (sum of up to 52 weeks). The Sponsor may 
terminate the study once 300 patients complete a total of 28 weeks of treatment and 100 patients 
complete a total of 52 weeks.  
Patients who completed the 12-week treatment period (± 4 days) for SGT-54-01 or SGT-54-02 
and did not miss more than one visit (Visit 3, 4 or 5) in SGT-54-01 or SGT-54-02 will be 
admitted into the 54-07 study after the Entry Criteria have been met and an ICF has been signed. 
Qualified patients will receive study product at Baseline and will be treated for up to 40 weeks. 
At each visit, the patients will be assessed for a 5-point scale IGA of rosacea. If a patient is 
assessed as “clear” (0) or “almost clear” (1), the patient will not be dispensed the study product. 
If a patient is assessed as “mild”, “moderate” or “severe” (score of 2, 3 or 4, respectively), study 
product will be dispensed and the patient will use the study product daily according to patient 
instructions. Rosacea Quality of Life Questionnaire (RosaQoL) will be completed at Baseline, 
Visits 5, 8, 11, and 14 and at End of Study or at early termination. The RosaQoL data of patients 
who were enrolled from SGT-54-01 or SGT-54-02, will be used from the questionnaire 
completed at Visit 6/Week 12 of SGT-54-01 or SGT-54-02. Rosacea erythema severity and 
telangiectasia assessments will be completed at all study visits. At each visit, the following safety 
measures will be recorded: monitoring for any local and systemic AEs, cutaneous safety 
(dryness, and scaling) and local tolerability (itching and burning/stinging) assessments on a scale 
ranging from 0 (None) to 3 (Severe), vital signs and physical examinations.  
A urine pregnancy test is required at all visits for all females of child-bearing potential.  
Clinical Evaluations will be performed at:  
1. Visit 1/Screening, only applies for new patients  
2. Visit 2/Baseline, Day 1 can also be Visit 6/Week 12, Day 85 of Study SGT-54-01 or 
Study SGT-54-02  


 
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3. Visit 3/Week 4, Day 29 (± 10 Days)  
4. Visit 4/Week 8, Day 57 (± 10 Days)  
5. Visit 5/Week 12, Day 85 (± 10 Days)  
6. Visit 6/Week 16, Day 113 (± 10 Days)  
7. Visit 7/Week 20, Day 141 (± 10 Days)  
8. Visit 8/Week 24, Day 169 (± 10 Days)  
9. Visit 9/Week 28, Day 197 (± 10 Days)  
10. Visit 10/Week 32, Day 225 (± 10 Days)  
11. Visit 11/Week 36, Day 253 (± 10 Days)  
12. Visit 12/Week 40, Day 281 (± 10 Days)/ End of Treatment/End of Study for patients who 
complete the study, early terminate, or if the Sponsor terminates the study prematurely.  
The study product will be administered in an open-label fashion, i.e., the treatment assignment 
will be known to the patient, to study personnel and Sol-Gel personnel and its representatives. 
6.1.1 
Schedule of Visits and Assessments 
The schedule of assessments can be found in Section 13.9 of the protocol. 
6.1.2 
Method of Assigning Subjects to Treatment Groups 
All patients will receive S5G4T-1. The patient assignment schedule will be a stratified by 
investigational site. Patients will be assigned through the Interactive Web Response System 
(IWRS) a unique ID indicating pump number. The format of the supplied number of pump is 
XXXX. At each visit the patient will return the pump and will be dispensed the next pump 
according to the IWRS assignment. 
6.1.3 
Blinding 
Not applicable. 


 
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7. EFFICACY AND SAFETY ENDPOINTS 
7.1 
Efficacy Endpoints 
This study is not intended to assess efficacy. 
IGA is included to determine the need for treatment and subsequent re-treatment after treatment 
course (in either Study SGT-54-01 or Study SGT-54-02) and any subsequent 4-week courses, if 
applicable. Certain efficacy data and endpoints will, however, be summarized. 
The number of retreatments and the number of treatment free days until the first retreatment 
(relapse) will be calculated as described in Section 8.7.2.2. 
RosaQoL will be completed at Baseline, Visits 5, 8, 11, 14, and End of Study. The RosaQoL 
data of patients who were enrolled from SGT-54-01 or SGT-54-02, will be used from the 
questionnaire completed at Visit 6/Week 12 of SGT-54-01 or SGT-54-02. 
Erythema severity and telangiectasia assessments will be completed at each study visit. 
7.2 
Safety Endpoints 
Safety will be evaluated by monitoring AEs, and cutaneous safety (dryness and scaling) and 
local tolerability (itching and burning/stinging) assessments.  
8. STATISTICAL AND ANALYTICAL PLANS 
8.1 
General Methodology 
All statistical processing will be performed using SAS® version 9.4 or later unless otherwise 
stated.  
Descriptive statistics will be used to provide an overview of the efficacy and safety results. For 
categorical parameters, the number and percentage of subjects in each category will be 
presented. For continuous parameters, descriptive statistics will include n (number of subjects), 
mean, standard deviation (SD), median, minimum (min) and maximum (max). 
No inferential testing or imputations for missing data will be performed. No interim analyses are 
planned. 
All analyses will be performed using the Safety Population of the study.  
Where applicable the analysis will be presented by overall treatment group in 54-07 as well as by 
treatment group assignment in 54-01/54-02.  


 
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8.1.1 
Statistical Analysis 
All analyses will be performed by QST using SAS® Version 9.4 or later. All summary tables 
and data listings will be prepared utilizing SAS® software. 
The standard operating procedures (SOPs) of QST will be followed in the creation and quality 
control of all data displays and analyses. 
All data listings will be by subject. Additionally, all listings except the screen failure and 
randomization listings will be by treatment.  
8.1.2 
Baseline Definition 
Baseline is defined as the last non-missing assessment prior to first application in 54-01/02. For 
all subjects enrolled in 54-01/54-02, the baseline values from 54-01/54-02 will be considered the 
baseline values for calculations in 54-07. Missing results will not be flagged as baseline. 
8.1.3 
Visit Windowing 
For subjects receiving S5G4T-1 in 54-01/54-02, data from 54-01/54-02 will be included in 
summaries of 54-07. For subjects receiving vehicle in 54-01/54-02, baseline values will be 
sourced from 54-01/54-02 and data from follow-up visits of 54-07 will be used in summaries. 
The table below details the analysis visits to be summarized and the associated visits from 54-
01/54-02 or 54-07 which will be sourced for each type of subject. 
 
 


 
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Analysis Visits for Efficacy and Safety Assessments 
Analysis Visit 
Subjects Receiving 
S5G4T-1 in 54-01/54-02 
Subjects Receiving 
vehicle in 54-01/54-02 
Week 4 
54-01/02 - Week 4 
54-07 - Week 4 
Week 8 
54-01/02 - Week 8 
54-07 - Week 8 
Week 12 
54-01/02 - Week 12 
54-07 - Week 12 
Week 16 
54-07 - Week 4 
54-07 - Week 16 
Week 20 
54-07 - Week 8 
54-07 - Week 20 
Week 24 
54-07 - Week 12 
54-07 - Week 24 
Week 28 
54-07 - Week 16 
54-07 - Week 28 
Week 32 
54-07 - Week 20 
54-07 - Week 32 
Week 36 
54-07 - Week 24 
54-07 - Week 36 
Week 40 
54-07 - Week 28 
54-07 - Week 40 
Week 44 
54-07 - Week 32 
Not available 
Week 48 
54-07 - Week 36 
Not available 
Week 52 
54-07 - Week 40 
Not available 
Data from 54-07 will be mapped to the appropriate analysis visit described above based on 
nominal visit indications. Data from Early Termination (ET) and unscheduled visits will be 
determined using analysis visit windows. The analysis visit windows for ET and unscheduled 
visits are presented in the following table.  
 
 


 
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SGT-54-07 Analysis Visit Windows for Efficacy and Safety Assessments 
Nominal Visit 
Target Study Day1 
Window (Days) 
Week 4 
29 
22 to 42 
Week 8 
57 
43 to 70 
Week 12 
85 
71 to 98 
Week 16 
113 
99 to 126 
Week 20 
141 
127 to 154 
Week 24 
169 
155 to 182 
Week 28 
197 
183 to 210 
Week 32 
225 
211 to 238 
Week 36 
253 
239 to 266 
Week 40 
281 
267 to 294 
Week 44 
309 
295 to 322 
Week 48 
337 
323 to 350 
Week 52 
365 
351 to 378 
1 Number of days since nominal Baseline visit of 54-07 
Data collected at ET and unscheduled visits prior to study day 22 will not be analyzed. Data 
collected at ET and unscheduled visits after study day 378 will not be included in analyses.   
The definition for the study day included in each study window is defined as below: 
 
Study Day prior to Day 1 = Visit Date – Day 1 Date 
 
Study Day on or after Day 1 = Visit Date – Day 1 Date + 1 
If an assessment’s mapped nominal visit is a visit at which the subject has data from a scheduled 
visit present, or if no analyses are planned for the assessment at the mapped nominal visit, the 
data collected at the ET or unscheduled visit will not be included in analyses.   
In the event of multiple values from unscheduled or ET assessments within an analysis visit 
window, the value closest to the scheduled visit target study day will be used for analyses. If 2 
values tie as closest to the time point (for example, one value is before and the other value is 
after the time point), then the later value will be selected.  
Data collected at all visits will be included in the data listings with the 54-07 analysis visit 
presented. 


 
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8.1.4 
Adjustments for Covariates 
Not applicable to this study. 
8.1.5 
Handling of Dropouts or Missing Data 
Incomplete start and end dates for medications will be imputed. Incomplete start dates for 
adverse events (AEs) will be imputed. Other data will not be imputed and will be summarized on 
an observed case basis. 
8.1.5.1 
Medication Date Imputation 
If the medication or procedure/therapy start date is incomplete, then it will be imputed as follows 
for the purpose of determining concomitant use:  
• If the start date is completely missing, the start date will be equal to the first dose date. 
However, if the stop date is not missing and is before the first dose date, then the stop 
date will be used instead. 
• If the start day is missing, the first day of the month will be used.  
• If the start day and month are missing, then the first day of the first month (January) will 
be used. 
If the medication or procedure/therapy stop date is incomplete, then it will be imputed as follows 
for the purpose of determining concomitant use:  
• If the stop date is completely missing and the medication is not ongoing, the stop date 
will be equal to the last dose date or date of completion/withdrawal, whichever is the 
latest.  
• If the stop day is missing, the last day of the month will be used.  
• If the stop day and month are missing, then the last day of the last month (December) will 
be used. 
8.1.5.2 
Adverse Event Start Date Imputation 
If the AE start date is incomplete, then it will be imputed as follows for the purpose of 
determining study day for the AE period breakdown described in Section 8.8.2:  


 
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• If the start date is completely missing, the start date will be equal to the first dose date. 
However, if the stop date is not missing and is before the first dose date, then the stop 
date will be used instead. 
• If the start day is missing, the first day of the month will be used.  
• If the start day and month are missing, then the first day of the first month (January) will 
be used. 
8.1.6 
Interim Analyses and Data Monitoring 
No interim analysis or data monitoring is planned for this study. 
8.1.7 
Multicenter Studies 
The clinical study will be conducted under a common protocol for each investigational site with 
the intention of pooling all the data for analysis. Every effort will be made to promote 
consistency in study execution at each study site. 
8.1.8 
Multiple Comparisons/Multiplicity 
No adjustments for multiple comparisons or multiplicity will be made. 
8.1.9 
Use of an Efficacy Subset of Subjects 
Not applicable to this study. 
8.1.10 
Active-Control Studies Intended to Show Equivalence 
Not applicable to this study. 
8.1.11 
Examination of Subgroups 
Not applicable to this study. 
8.2 
Disposition of Subjects 
The number of subjects included in the Safety population will be summarized for all subjects, for 
subjects that received S5G4T-1 in 54-01/54-02, and for subjects that received vehicle in 54-
01/54-02. The number of subjects enrolled, completed, and discontinued (including the reasons 
for discontinuation) will be summarized similarly. 


 
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Subjects who are excluded from the Safety population will be summarized by the reasons for 
exclusion. 
8.3 
Protocol Deviations 
All protocol deviations will be reported to the sponsor and recorded throughout the study. 
Protocol deviations will not be entered into the database. SolGel will provide a list of protocol 
deviations to QST. A tabulation of protocol deviations will be presented in a data listing. 
8.4 
Data Sets Analyzed 
Subjects will be presented/summarized based on the primary reason for exclusion.   
8.4.1 
Safety Population 
All analyses will be performed using the Safety Population of the study. All patients who receive 
at least one confirmed dose of S5G4T-1 and have at least one assessment will be included in the 
Safety Population.  
8.5 
Demographic and Other Baseline Characteristics 
All baseline summaries will be done on the Safety population. 
Sex (categorical), race (categorical), and ethnicity (categorical) will be summarized by counts 
and percentages. Age (continuous), height (cm) (continuous), and weight (kilograms (kg)) 
(continuous), and body mass index (BMI) (continuous) will be summarized with descriptive 
statistics.  
Age will be calculated as the difference in days between the date of birth and the date of 
informed consent and converted to years by dividing the number of days by 365.25 and using a 
floor function to drop the decimal portion. In case the exact birth day is missing, day 15 will be 
used. The BMI will be calculated as weight (kg) divided by squared height (m2). 
Medical histories will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA) dictionary and presented in a by-subject listing. All medical history for rollover 
subjects will be entered into 54-07 database and therefore medical history data will not be pulled 
from the 54-01 or 54-02 studies. The date of rosacea diagnosis for rollover subjects will be 
pulled from the 54-01 or 54-02 study.  
The medical history data will be summarized with frequencies and percentages of patients with 
at least one medical history term reported, and patient frequencies and percentages on the System 


 
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Organ Class (SOC) and Preferred Term levels. The number of events will also be summarized. 
The table will be sorted by overall descending frequency of SOC and then, within a SOC, by 
overall descending frequency of Preferred Term. 
8.6 
Prior and Concomitant Medications 
Concomitant medications will be coded to preferred name and Anatomical Therapeutic Chemical 
(ATC) classification of ingredients using the World Health Organization (WHO) Drug Global 
Dictionary, Format B3, Version March 1, 2018. Ongoing medications for rollover subjects will 
be entered into 54-07. Only medications that are not ongoing in 54-01 or 54-02 will be pulled 
forward for subjects who received S5G4T-1 in 54-01 or 54-02. 
Medications which start prior to first application of S5G4T-1 (from 54-01/02 or 54-07) will be 
considered prior medications. Ongoing medications and medications ending after the date of first 
application (in 54-01/02 or 54-07) will be considered concomitant medications. If the date of 
first application is unknown and the medication is not listed as ongoing the interval will be 
considered “unknown”. If the date of first application is unknown and the medication is listed as 
ongoing the interval will be considered concomitant.  
Incomplete medication start and end dates will be imputed as described in Section 8.1.5.1. 
A by-subject listing of all prior and concomitant medications will be presented for the Safety 
population.  
8.7 
Prior and Concomitant Procedures/Therapies 
Procedures/therapies will be coded using the MedDRA dictionary. Ongoing procedures/therapies 
for rollover subjects will be entered into 54-07. Only procedures/therapies that are not ongoing in 
54-01 or 54-02 will be pulled forward for subjects who received S5G4T-1 in 54-01 or 54-02. 
Procedures/therapies which start prior to first application of S5G4T-1 (from 54-01/02 or 54-07) 
will be considered prior procedures/therapies. Ongoing procedures/therapies and 
procedures/therapies ending after the date of first application (in 54-01/02 or 54-07) will be 
considered concomitant procedures/therapies. If the date of first application is unknown and the 
procedures/therapies is not listed as ongoing the interval will be considered “unknown”. If the 
date of first application is unknown and the procedures/therapies is listed as ongoing the interval 
will be considered concomitant.  
Incomplete procedures/therapies start and end dates will be imputed as described in Section 
8.1.5.1. 


 
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A by-subject listing of all prior and concomitant procedure/therapies will be presented for the 
Safety population.  
8.8 
Analysis of Efficacy 
All efficacy analysis will be conducted on the Safety population. 
8.8.1 
IGA 
Descriptive statistics will be used to summarize the assessment of efficacy. IGA scores will be 
summarized at Baseline (see definition of baseline in Section 8.1.2) and every 4 weeks through 
end of the study. The number and percentage of patients who achieve treatment success at the 
scheduled study visits will be tabulated. A patient will be considered a success if their IGA score 
is clear or almost clear.  
In addition to the above summary a by-subject listing of all IGA results will be presented.  
8.8.2 
Retreatments  
The number of retreatments is defined as the number of clinical confirmations of the condition 
for which the subject was initially treated after the first treatment period with S5G4T-1. For 
rollover subjects previously treated with vehicle, this is the number of treatments after the initial 
treatment in 54-07. For rollover subjects previously treated with S5G4T-1, this is the number of 
treatments in 54-07 following the cessation of the treatment which began in 54-01 or 54-02. A 
clinical confirmation of the condition will be defined as IGA no longer being clear or almost 
clear after a previous IGA of clear or almost clear. When a subject has a clear or almost clear 
IGA in 54-07, it is expected they were instructed not to dose until the IGA reached mild, 
moderate or severe. 
The number of treatment free days until the first retreatment (relapse) will be calculated and 
summarized. Relapse will be defined as a subject no longer having an IGA of clear or almost 
clear after a previous visit IGA of clear or almost clear. When a subject has a clear or almost 
clear IGA in 54-07, it is expected they were instructed not to dose until the IGA reached mild, 
moderate or severe. Number of treatment free days until first retreatment is defined as the 
number of days between an initial IGA assessment of clear or almost clear while the subject was 
receiving S5G4T-1 until an IGA of mild, moderate or severe. 
For rollover subjects previously treated with vehicle, the number of treatment free days will be 
the number of days between the end of their first treatment of S5G4T-1 in 54-07 (when the 
subject has an IGA of clear or almost clear) and the start of the next treatment in 54-07 (when the 


 
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subject has an IGA indicating they should dose) if they treated with S5G4T-1 again or the end of 
the subject’s participation in 54-07. For rollover subjects previously treated with S5G4T-1, the 
number of treatment free days will be the number of days between the end of the treatment that 
began in 54-01 or 54-02 (when the subject has an IGA of clear or almost clear) and the start of 
the next treatment in 54-07 (when the subject has an IGA indicating they should dose) if they 
treated with S5G4T-1 again or the end of the subject’s participation in the 54-07.  
Descriptive statistics for time to relapse (number of treatment free days until retreatment) and 
number of retreatments will be presented. A confidence interval (CI) for the median time to 
relapse will be presented using the Kaplan–Meier method. Patients who discontinue in 54-07 
while not being treated and had not yet previously relapsed will be considered censored in the 
Kaplan–Meier analysis. 
8.8.2.1 
RosaQoL 
The mean change in RosaQoL subscale scores from Baseline to Weeks 12, 24, 36, 48 and 52 will 
be summarized using descriptive statistics. 
The subscores for the RosaQoL are computed as follows:  
Total Score: the unweighted mean of all RosaQoL questions 
Symptom subscale score: the unweighted mean of the following symptom questions 
My rosacea burns or stings (item #2) 
My rosacea is irritated (item #6) 
My rosacea makes my skin sensitive (item #9) 
My skin feels bumpy (uneven, not smooth, irregular) (item #16) 
My skin flushes (item #17) 
My skin gets irritated easily (cosmetics, aftershaves, cleansers) (item #18) 
My eyes bother me (feels dry or gritty) (item #19) 
Functional subscale score: the unweighted mean of the following functional questions 
I try to cover up my rosacea (with make-up) (item #13) 
I avoid certain foods or drinks because of my rosacea (item #15) 
I avoid certain environments (heat, humidity, cold) because of my rosacea (item #21) 


 
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Emotion subscale score: the unweighted mean of the following emotion questions 
I worry that my rosacea may be serious (item #1) 
I worry about getting scars from my rosacea (item #3) 
I worry that my rosacea may get worse (item #4) 
I worry about side effects from rosacea medications (item #5) 
I am embarrassed by my rosacea (item #7) 
I am frustrated by my rosacea (item #8) 
I am annoyed by my rosacea (item #10) 
I am bothered by the appearance of my skin (redness, blotchiness) (item #11) 
My rosacea makes me feel self-conscious (item #12) 
I am bothered by persistence/reoccurrence of my rosacea (item #14) 
I think about my rosacea (item #20) 
Each individual item should be scored as follows: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 
and 5=All the time. Missing data values will not be used. If a subscale has items with missing 
results, the subscore and the total will not be calculated.  
8.8.2.2 
Rosacea Erythema and Telangiectasia Assessments 
Rosacea erythema and telangiectasia assessments will be summarized at Baseline and every 4 
weeks by counts and percentages. A by-subject listing will also be presented.  
8.9 
Safety Evaluation 
8.9.1 
Extent of Exposure 
The extent of exposure to study product in each treatment group will be summarized by total 
number of days of exposure to S5G4T-1, total number of applications, number of missed 
applications, and number of applications the subject did not take because they were instructed 
not to dose. If the CRF reason for not dosing is anything but “Per Principal Investigator (PI) 
Instruction” it will be counted as a non-instructed missed dose. If the CRF reason for not dosing 
is “Per PI Instruction” it will be counted as an instructed missed dose. 
The total number of days of exposure to S5G4T-1 is as follows:  


 
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Date of last documented dose of S5G4T-1 - Date of first documented dose of S5G4T-1 +1 
The total number of applications taken is as follows: 
Sum of: [(End date of dosing interval from the CRF – Start date of dosing interval from the CRF 
+ 1)*Number of doses taking in dosing interval on CRF] for all dosing intervals on the CRF 
The total number of non-instructed missed applications taken is as follows: 
Sum of: (End date of dosing interval from the CRF with reason of “Other, specify reason” – Start 
date of dosing interval from the CRF + 1) for all dosing intervals on the CRF marked with a dose 
of 0 and with reason of “Other, specify reason”. 
The total number of instructed missed applications is as follows: 
Sum of: (End date of dosing interval from the CRF with reason of “Per PI Instruction” – Start 
date of dosing interval from the CRF + 1) for all dosing intervals on the CRF marked with a dose 
of 0 and with reason of “Per PI Instruction”. 
Subjects who are lost to follow-up or have a dosing record with an unknown number of doses or 
unknown dates of the dosing intervals will not have extent of exposure variables calculated.  
8.9.2 
Adverse Events 
AEs from 54-01/02 will be included in the analysis for 54-07. All AEs that were reported as 
ongoing in 54-01/02 will be added into the CRF for 54-07, while AEs reported as 
recovered/resolved will be pulled forward programmatically into 54-07.  
AEs occurring during the study will be recorded and classified on the basis of MedDRA 
terminology. Descriptions of AEs will include the date of onset, the date the AE ended, the 
severity of the AE, the relationship to study product, the action taken regarding study product 
usage, the action taken to treat the AE, and the outcome. All reported treatment-emergent AEs 
(TEAEs) will be summarized by the number of patients reporting AEs, system organ class, 
severity, seriousness, and relationship to study product. TEAEs are those AEs with an onset on 
or after the date of the first study product application. For AEs recorded in the 54-07 study if the 
AE is not indicated as prior to first application on the CRF then it will be considered a TEAE. 
AEs from 54-01/02 for subjects who received S5G4T-1 in 54-01 or 54-02 will be considered a 
TEAE if they were considered at TEAE in the 54-01/02 study. AEs (including ongoing) from 54-
01/02 study for subjects who received vehicle in 54-01 or 54-02 will be considered pre-
treatment. 


 
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AEs will be summarized by period (and total) and by severity. Each patient will be counted only 
once within a SOC or a Preferred Term by using the AEs with the highest severity within each 
category. 
AEs will be summarized by period (and total) and by relationship to study product. Each patient 
will be counted only once within a system organ class or a preferred term by using the AEs with 
the greatest relationship within each category. 
If relationship to study drug is reported as definitely, probably, or possible, then this is defined as 
related. If relationship to study drug is reported as unlikely or not related, then this is defined as 
unrelated. 
TEAEs will be summarized in total as well as by the following periods based on time of onset in 
relation to date of first application of S5G4T-1, based on the definitions below. Start dates will 
be imputed as described in Section 8.1.5.2. 
• 0-12 Weeks 
 
0 ≤ onset day ≤ 85 
• >12-28 Weeks  
86 ≤ onset day ≤ 197 
• >28-52 Weeks  
198 ≤ onset day ≤ 365 
• >52 Weeks 
 
onset day ≥ 366 
All information pertaining to AEs noted during the study will be listed by patient, detailing 
verbatim given by the investigator, preferred term, system organ class, start date, stop date, 
severity, actions taken, and drug relatedness. The AE onset will also be shown relative (in 
number of days) to the day of initial application of the study product. 
Serious adverse events (SAEs) will be tabulated by patient. 
In addition, a list of patients who discontinued from the study and a list of patients who 
experienced SAEs will also be provided. 
8.9.3 
Clinical Laboratory Evaluation 
Urine pregnancy test results will be presented in a by-subject listing.  
8.9.4 
Other Observations Related to Safety 
8.9.4.1 
Cutaneous Safety Assessments 
Descriptive statistics by visit will be provided for dryness and scaling.  


 
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Cutaneous Safety Assessments will be presented in a by-subject listing.  
8.9.4.2 
Local Tolerability Assessments 
Descriptive statistics by visit will be provided for itching and burning/stinging.  
Local tolerability data will be presented in a by-subject listing.  
8.9.4.3 
Vital Signs 
Vital sign measurements include heart rate (HR), sitting blood pressure (BP) (both systolic and 
diastolic), body temperature, and weight. The data will be summarized with descriptive statistics 
by visit. In addition, the changes from Baseline will be summarized with descriptive statistics. 
Vital sign data will be presented in a by-subject listing.  
8.9.4.4 
Physical Examination 
Physical examination data will be presented in a by-subject listing.  
9. DETERMINATION OF SAMPLE SIZE 
The sample size for this study was based on the minimum requirement for a long-term safety 
study. 
10. CHANGES IN THE PLANNED ANALYSES 
The protocol was written in a way that subjects who did not participate in 54-01 or 54-02 could 
be enrolled into 54-07. When the SAP was created, 54-07 was fully enrolled, and no subject was 
enrolled who did not complete the 54-01 or 54-02 study. The SAP was written such that any text 
from the protocol that discusses the new subjects was excluded. 
11. REFERENCES 
1. Breneman D, Savin R., VandePol C., Vamvakias G., Levy S., Leyden J. Double-blind, 
randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin 
topical gel in the treatment of patients with moderate to severe rosacea. Int. J of Derm. 
2004; 43(5):381-387.  
2. Fyrand O, Jakobsen HB. Water-based versus alcohol-based benzoyl peroxide 
preparations in the treatment of acne vulgaris. Dermatolgica 1986 172:263-267.  


 
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3. Jansen T and Plewig G. Rosacea: classification and treatment. JR Soc Med. 1997; 
90(3):144-150.  
4. Leyden JJ, Hickman JG, Jarratt MT, Stewart DM, Levy SF. The efficacy and safety of a 
combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide 
alone and a benzoyl peroxide/erythromycin combination product. J Cutan Med Surg. 
2001. 5:37-42.  
5. McDonnell JK and Tomecki KJ. Rosacea: an update. Clev Clinic J Med. 2000; 
67(8):587-590.  
6. Montes LF, Cordero AA., Kriner J., Loder J., Flanagan AD. Topical treatment of acne 
rosacea with benzoyl peroxide acetone gel. Cutis 1983; 32(2):185-190.  
7. Thiboutot DM, Weiss J, Bucko A, Eichenfield L, Jones T, Clark S, Liu Y, Graeber M, 
Kang S. Adapalen-BPO Study Group. Adapalene-benzoyl peroxide, a fixed-dose 
combination for the treatment of acne vulgaris: results of a multicenter, randomized 
double-blind, controlled study. J Am Acad Dermatol. 2007. 57:791-799.  
8. Tschen EH, Katz HI, Jones TM, Monroe EW, Kraus SJ, Connolly MA, Levy SF. A 
combination benzoyl peroxide and clindamycin topical gel compared with benzoyl 
peroxide, clindamycin phosphate, and vehicle in the treatment of acne vulgaris. Cutis. 
2001. 67:165-169.  
9. Weiss JW, Shavin J, Davis M. Preliminary results of a nonrandomized, multicenter, 
open-label study of patient satisfaction after treatment with combination benzoyl 
peroxide/clindamycin topical gel for mild to moderate acne. Clin Ther. 2002. 24:1706-
1717. 
 
 


 
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12. INDEX OF PLANNED TABLES 
Table 14.0.1: Summary of Subject Completion/Discontinuation  (All Enrolled Subjects) ...........29 
Table 14.0.2.1: Summary of Subject Enrollment and Evaluability  (All Enrolled Subjects) ........30 
Table 14.1.1.1: Summary of Subject Demographic Characteristics  (Safety Population) .............31 
Table 14.1.2.1: Subject Baseline Characteristics  (Safety Population) ..........................................32 
Table 14.1.3.1: Summary of Medical History by System Organ Class and Preferred 
Term  (Safety Population) .....................................................................34 
Table 14.1.4.1: Summary of Concomitant Medications by ATC Level 2 and Preferred 
Name  (Safety Population) ....................................................................35 
Table 14.2.1.1: Summary of Investigator Global Assessment at Baseline and Week 
40  (Safety Population)..........................................................................36 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each 
Evaluation  (Safety Population) ............................................................37 
Table 14.2.2.1: Summary of RosaQoL Questionnaire Responses at Baseline and Week 
40  (Safety Population)..........................................................................44 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each 
Evaluation  (Safety Population) ............................................................48 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation   (Safety Population) ........54 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation   (Safety Population) 59 
Table 14.2.5: Summary of Reoccurrence   (Safety Population) ....................................................64 
Table 14.3.0.1: Summary of Extent of Exposure  (Safety Population) .........................................65 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability 
Evaluations  (Safety Population) ...........................................................67 
Table 14.3.1.2.1: Summary of Treatment-Emergent Adverse Event 
Characteristics  (Safety Population) ......................................................72 
Table 14.3.1.2.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term (Safety Population)......................................74 
Table 14.3.1.2.3: Summary of  Treatment-Emergent 
Adverse Events by Severity  (Safety Population) .................................75 
Table 14.3.1.2.4: Summary of Treatment-Emergent Adverse Events by Relationship to Study 
Drug (Safety Population) ......................................................................76 
Table 14.3.1.3.1: Summary of Treatment-Emergent Adverse Event Characteristics - By 
Period  (Safety Population) ...................................................................77 


 
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Table 14.3.1.3.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class and Preferred Term – By Period (Safety Population) .................79 
Table 14.3.1.3.3: Summary of Treatment-Emergent Adverse Events by Severity – By 
Period  (Safety Population) ...................................................................80 
Table 14.3.1.3.4: Summary of Treatment-Emergent Adverse Events by Relationship to Study 
Drug – By Period (Safety Population) ..................................................81 
Table 14.3.1.4.1: Summary of Treatment-Emergent Serious Adverse Event 
Characteristics  (Safety Population) ......................................................82 
Table 14.3.1.4.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term (Safety Population) ..............84 
Table 14.3.1.4.3: Summary of Serious Treatment-Emergent 
Adverse Events by Severity  (Safety Population) .................................85 
Table 14.3.1.4.4: Summary of Treatment-Emergent Serious Adverse Events by Relationship to 
Study Drug (Safety Population) ............................................................86 
Table 14.3.1.5.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics – By 
Period  (Safety Population) ...................................................................87 
Table 14.3.1.5.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term – By Period (Safety 
Population) ............................................................................................89 
Table 14.3.1.5.3: Summary of Treatment-Emergent Serious Adverse Events by Severity – By 
Period  (Safety Population) ...................................................................90 
Table 14.3.1.5.4: Summary of Treatment-Emergent Serious Adverse Events by Relationship to 
Study Drug – By Period (Safety Population) ........................................91 
Table 14.3.1.4.1: Summary of Vital Signs  (Safety Population) ...................................................92 
 


 
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Table 14.0.1: Summary of Subject Completion/Discontinuation 
 (All Enrolled Subjects) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Completed Study 
Yes 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reason for Discontinuation 
Adverse Event 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lost to Follow-Up 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Lack of Efficacy 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Pregnancy 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Protocol Violation 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Withdrawal by Subject 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Study Terminated by Sponsor 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Physician Decision 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Worsening of Condition 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Other 
xx 
( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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Table 14.0.2.1: Summary of Subject Enrollment and Evaluability 
 (All Enrolled Subjects) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Number of Subjects Included in the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Number of Subjects Excluded from the Safety Population 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Reasons Excluded from the Safety Populationa 
No Documented use of Study Drug 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
No Post Baseline Safety Assessment 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a  Table includes primary reason (assigned in order presented in table) for reason subject was excluded. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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Table 14.1.1.1: Summary of Subject Demographic Characteristics 
 (Safety Population) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Age (years) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Sex 
n 
xx 
xx 
xx 
Male 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Female 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Ethnicity 
n 
xx 
xx 
xx 
Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Not Hispanic or Latino 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Not Reported/Unknown 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
Race 
n 
xx 
xx 
xx 
American Indian or Alaska Native 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Asian 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Black or African American 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Native Hawaiian or Other Pacific Islander 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
White 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Multiple/Othera 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a See Listing 16.2.4.1 for a complete list of other races. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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Table 14.1.2.1: Subject Baseline Characteristics 
 (Safety Population) 
(Page 1 of 2) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Height (cm) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Weight (kg) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
BMI (kg/m2) 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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Table 14.1.2.1: Subject Baseline Characteristics 
 (Safety Population) 
(Page 2 of 2) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Inflammatory Lesion Count 
n 
xx 
xx 
xx 
Mean 
xx.x 
xx.x 
xx.x 
SD 
xx.xx 
xx.xx 
xx.xx 
Median 
xx.x 
xx.x 
xx.x 
Min. to Max. 
xx to xx 
xx to xx 
xx to xx 
Investigator Global Assessment 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 – Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.1.3.1: Summary of Medical History by System Organ Class and Preferred Term 
 (Safety Population) 
(Page 1 of xx) 
 
System Organ Class 
Preferred Term 
 
  
E-BPO 5% Cream  
 
(N=xxx)  
 
 
By Subjecta 
 
 
By Eventb 
 
Number (%) of Subjects Reporting at Least One Medical History Term 
xx ( 
xx.x%) 
System Organ Class 
xx ( 
xx.x%) 
xx 
Preferred Term 
xx ( 
xx.x%) 
xx 
 
 
a Counts reflect number of subjects reporting one or more medical history terms that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once. Percentages are based on the number of subjects in the safety population.  
b Counts reflect number of medical history terms that map to MedDRA.  
Note:  MedDRA Version 21.0 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
{NOTE TO PROGRAMMER: The table will be sorted by overall descending frequency of SOC and then, within a SOC, by overall descending 
frequency of Preferred Term} 
 
 


 
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CONFIDENTIAL 
 
Table 14.1.4.1: Summary of Concomitant Medications by ATC Level 2 and Preferred Name 
 (Safety Population) 
(Page 1 of xx) 
 
ATC Level 2 Terma 
Preferred Name 
 
  
E-BPO 5% Cream  
 
(N=xxx)  
 
Number (%) of Subjects Reporting at Least One Concomitant Medication 
xx ( 
xx.x%) 
ATC Level 2 Term 
xx ( 
xx.x%) 
Preferred Name 
xx ( 
xx.x%) 
 
 
a Counts reflect number of subjects reporting one or more medications that map to the WHO term. At each level of summarization (ATC Level 2 Term or  
Preferred Name) subjects are counted once. Percentages are based on the number of subjects in the safety population.  
Note: WHO Drug Global Dictionary, Format B3, Version March 1, 2018 
Concomitant medications are those used on/after the date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07).  
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.1: Summary of Investigator Global Assessment at Baseline and Week 40 
 (Safety Population) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 40/ETb 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based on nominal visit Week 40/ET from SGT-54-07. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 1 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 4b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 2 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 8b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 12b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 39 of 131 
 
CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 3 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 16b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 20b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 4 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 28b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 5 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 32b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 36b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 6 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 40b 
n 
xx 
xx 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 44b 
n 
xx 
NA 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 43 of 131 
 
CONFIDENTIAL 
 
Table 14.2.1.2: Summary of Investigator Global Assessment at Each Evaluation 
 (Safety Population)  
(Page 7 of 7) 
 
Investigator Global Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
n 
xx 
NA 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
Week 52b 
n 
xx 
NA 
xx 
0 - Clear 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Almost Clear 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
4 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
Achieving Clear or Almost Clear 
 Success 
xx ( xx.x%) 
xx ( xx.x%) 
 Failure 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 44 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.1: Summary of RosaQoL Questionnaire Responses at Baseline and Week 40 
 (Safety Population) 
(Page 1 of 4) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
 
Week 40/ETb 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based on nominal visit Week 40/ET from SGT-54-07. 
Note: Change calculated as Week 40/ET – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 45 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.1: Summary of RosaQoL Questionnaire Responses at Baseline and Week 40 
 (Safety Population) 
(Page 2 of 4) 
 
Symptom Subscale Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
 
Week 40/ETb 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based on nominal visit Week 40/ET from SGT-54-07. 
Note: Change calculated as Week 40/ET – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 46 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.1: Summary of RosaQoL Questionnaire Responses at Baseline and Week 40 
 (Safety Population) 
(Page 3 of 4) 
 
Functional Subscale Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
 
Week 40/ETb 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based on nominal visit Week 40/ET from SGT-54-07. 
Note: Change calculated as Week 40/ET – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.2.1: Summary of RosaQoL Questionnaire Responses at Baseline and Week 40 
 (Safety Population) 
(Page 4 of 4) 
 
Emotional Subscale Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
 
Week 40/ETb 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based on nominal visit Week 40/ET from SGT-54-07. 
Note: Change calculated as Week 40/ET – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 48 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 1 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Week 12b 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions.  
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21.  
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 49 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 2 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 50 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 3 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 36b 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 51 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 4 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 40b 
n 
 
 
NA 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
NA 
 
 
xx 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 52 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 5 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
n 
 
 
xx 
 
 
NA 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
NA 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 53 of 131 
 
CONFIDENTIAL 
 
Table 14.2.2.2: Summary of RosaQoL Questionnaire Responses at Each Evaluation 
 (Safety Population) 
(Page 6 of 24) 
 
Total Score 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 52b 
n 
 
 
xx 
 
 
NA 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
SD 
 
 xx.xx 
 
 xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
xx to xx 
 
xx to xx 
Absolute Change from Baseline 
 n 
 
 
xx 
 
 
NA 
 
 
xx 
 Mean 
 
 
xx.x 
 
 
xx.x 
 SD 
 
 xx.xx 
 
 xx.xx 
 Median 
 
 
xx.x 
 
 
xx.x 
 Min. to Max. 
 
xx to xx 
 
xx to xx 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Change calculated as post-Baseline – Baseline. Negative values represent decrease from Baseline. 
 
Total Score calculated from the unweighted mean of all RosaQoL questions. 
 
Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
 
Functional Subscale Score calculated from items 13, 15, and 21. 
 
Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat these pages for [Symptom Subscale Score, Functional Subscale Score and Emotional Subscale Score]. 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 54 of 131 
 
CONFIDENTIAL 
 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation 
  (Safety Population) 
(Page 1 of 5) 
 
Rosacea Erythema Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 4b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 8b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 55 of 131 
 
CONFIDENTIAL 
 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation 
  (Safety Population) 
(Page 2 of 5) 
 
Rosacea Erythema Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 12b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 16b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 20b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 56 of 131 
 
CONFIDENTIAL 
 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation 
  (Safety Population) 
(Page 3 of 5) 
 
Rosacea Erythema Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 28b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 32b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 57 of 131 
 
CONFIDENTIAL 
 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation 
  (Safety Population) 
(Page 4 of 5) 
 
Rosacea Erythema Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 36b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 40b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 44b 
n 
xx 
NA 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 58 of 131 
 
CONFIDENTIAL 
 
Table 14.2.3: Summary of Erythema Assessment at Each Evaluation 
  (Safety Population) 
(Page 5 of 5) 
 
Rosacea Erythema Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
n 
xx  
NA  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
Week 52b 
n 
xx 
NA 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 59 of 131 
 
CONFIDENTIAL 
 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation 
  (Safety Population) 
(Page 1 of 5) 
 
Telangiectasia Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 4b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 8b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template           
    Page 60 of 131 
 
CONFIDENTIAL 
 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation 
  (Safety Population) 
(Page 2 of 5) 
 
Telangiectasia Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 12b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 16b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 20b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation 
  (Safety Population) 
(Page 3 of 5) 
 
Telangiectasia Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 28b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 32b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation 
  (Safety Population) 
(Page 4 of 5) 
 
Telangiectasia Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 36b 
n 
xx  
xx  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 40b 
n 
xx 
xx 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
xx ( xx.x%) 
Week 44b 
n 
xx 
NA 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.4: Summary of Telangiectasia Assessment at Each Evaluation 
  (Safety Population) 
(Page 5 of 5) 
 
Telangiectasia Assessment 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
n 
xx  
NA  
xx  
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
Week 52b 
n 
xx 
NA 
xx 
0 - None 
xx ( xx.x%) 
xx ( xx.x%) 
1 - Mild 
xx ( xx.x%) 
xx ( xx.x%) 
2 - Moderate 
xx ( xx.x%) 
xx ( xx.x%) 
3 - Severe 
xx ( xx.x%) 
xx ( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.2.5: Summary of Reoccurrence  
 (Safety Population) 
 
 
 
  
E-BPO 5% Cream  
 
(N=xxx)  
 
Number of Retreatments 
n 
 
 
xx 
Mean 
 
 
xx.x 
SD 
 
 
xx.xx 
Median 
 
 
xx.x 
Min. to Max. 
 
 xx to xx 
Number of Treatment Free Days Until First Retreatment 
n 
 
 
xx 
Medianc (days) 
 
 
xx.x 
95% Confidence Intervalc 
 
(xx.x, xx.x) 
 
 
a Number of retreatments is defined as the number of times a subject’s IGA goes from clear or almost clear to mild, moderate or severe after the subject was 
clear or almost clear while receiving E-BPO 5% Cream.  
b Number of treatment free days until first retreatment is defined as the number of days between an initial IGA assessment of clear or almost clear while the  
subject was receiving E-BPO 5% Cream until an IGA of mild, moderate or severe. 
c Median and 95% confidence intervals based on Kaplan-Meier method. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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Table 14.3.0.1: Summary of Extent of Exposure 
 (Safety Population)  
 (Page 1 of 2) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Total Number of Days of Exposure 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 
xx.xx 
 
 
xx.xx 
 
 
xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
 xx to xx 
 
 xx to xx 
 
 xx to xx 
 
 
 
Total Number of Applications 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 
xx.xx 
 
 
xx.xx 
 
 
xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
 xx to xx 
 
 xx to xx 
 
 xx to xx 
Total Number of Non-Instructed Missed Applicationsa
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 
xx.xx 
 
 
xx.xx 
 
 
xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
 xx to xx 
 
 xx to xx 
 
 xx to xx 
 
 
a Non-Instructed missed applications are missed doses on the CRF with reason of “Other, specify reason”. 
b Instructed missed applications are missed doses on the CRF with reason of “Per PI Instruction”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.0.1: Summary of Extent of Exposure 
 (Safety Population)  
 (Page 2 of 2) 
 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Total Number of Instructed Missed Applicationsb 
n 
 
 
xx 
 
 
xx 
 
 
xx 
Mean 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
SD 
 
 
xx.xx 
 
 
xx.xx 
 
 
xx.xx 
Median 
 
 
xx.x 
 
 
xx.x 
 
 
xx.x 
Min. to Max. 
 
 xx to xx 
 
 xx to xx 
 
 xx to xx 
 
 
a Non-Instructed missed applications are missed doses on the CRF with reason of “Other, specify reason”. 
b Instructed missed applications are missed doses on the CRF with reason of “Per PI Instruction”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 
 


 
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CONFIDENTIAL 
 
 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability Evaluations 
 (Safety Population) 
 (Page 1 of 20) 
 
Dryness 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
 
Week 4b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
Week 8b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 68 of 131 
 
CONFIDENTIAL 
 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability Evaluations 
 (Safety Population) 
 (Page 2 of 20) 
 
Dryness 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 12b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
 
Week 16b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
Week 20b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 69 of 131 
 
CONFIDENTIAL 
 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability Evaluations 
 (Safety Population) 
 (Page 3 of 20) 
 
Dryness 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
 
Week 28b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
Week 32b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 70 of 131 
 
CONFIDENTIAL 
 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability Evaluations 
 (Safety Population) 
 (Page 4 of 20) 
 
Dryness 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 36b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
 
Week 40b 
n 
xx 
xx 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
xx 
( xx.x%) 
Week 44b 
n 
xx 
NA 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
 


 
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    Page 71 of 131 
 
CONFIDENTIAL 
 
Table 14.3.1.1: Summary of  Cutaneous Safety and Tolerability Evaluations 
 (Safety Population) 
 (Page 5 of 20) 
 
Dryness 
  
SGT-54-01/SGT-54-02 
 
Vehicle Cream  
 
    (N=xxx)  
 
  
SGT-54-01/SG-54-02  
 
E-BPO 5% Cream  
 
(N=xxx)  
 
  
SGT-54-07 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
n 
xx 
NA 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
Week 52b 
n 
xx 
NA 
xx 
0 – None 
xx 
( xx.x%) 
xx 
( xx.x%) 
1 – Mild 
xx 
( xx.x%) 
xx 
( xx.x%) 
2 – Moderate 
xx 
( xx.x%) 
xx 
( xx.x%) 
3 – Severe 
xx 
( xx.x%) 
xx 
( xx.x%) 
 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE,TIME) 
 
Repeat these pages for [Scaling, Itching and Burning/Stinging] 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.2.1: Summary of Treatment-Emergent Adverse Event Characteristics 
 (Safety Population) 
(Page 1 of 2) 
  
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Subjects Reporting Any Treatment-Emergent Adverse Event 
xx  
( xx.x%) 
Number of Treatment-Emergent Adverse Events 
xx 
Subjects Reporting Any Serious Treatment-Emergent Adverse Event 
xx  
( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events 
xx 
Subjects Reporting Treatment-Emergent Adverse Event with Outcome of Fatal 
xx  
( xx.x%) 
Number of Treatment-Emergent Adverse Events with Outcome of Fatal 
xx 
Subjects Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event 
xx  
( xx.x%) 
Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug 
xx 
Subjects Who Discontinued from the Study Due to a Treatment-Emergent Adverse Event 
xx  
( xx.x%) 
Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study 
xx 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.2.1: Summary of Treatment-Emergent Adverse Event Characteristics 
 (Safety Population) 
(Page 2 of 2) 
  
 
E-BPO 5% Cream 
 
(N=xxx)  
 
By Maximum Severity 
Severe 
xx  
( xx.x%) 
Moderate 
xx  
( xx.x%) 
Mild 
xx  
( xx.x%) 
By Strongest Relationship to Study Drug 
Related 
xx  
( xx.x%) 
Not Related 
xx  
( xx.x%) 
Maximum Severity within Relationship to Study Drug 
Related 
 Severe 
xx  
( xx.x%) 
 Moderate 
xx  
( xx.x%) 
 Mild 
xx  
( xx.x%) 
Not Related  
 Severe 
xx  
( xx.x%) 
 Moderate 
xx  
( xx.x%) 
 Mild 
xx  
( xx.x%) 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.2.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  
( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  
( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.2.3: Summary of  Treatment-Emergent Adverse Events by Severity 
 (Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
Severity 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( 
xx.x%) 
Moderate 
xx  ( 
xx.x%) 
Mild 
xx  ( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( 
xx.x%) 
Moderate 
xx  ( 
xx.x%) 
Mild 
xx  ( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or 
Preferred Term) subjects are counted once under the greatest reported severity. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.2.4: Summary of Treatment-Emergent Adverse Events by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa  
Preferred Term  
 
Relationship 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( 
xx.x%) 
Not Related 
xx  ( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( 
xx.x%) 
Not Related 
xx  ( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or 
Preferred Term) subjects are counted once under the greatest reported relationship. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.3.1: Summary of Treatment-Emergent Adverse Event Characteristics - By Period 
 (Safety Population) 
(Page 1 of 2) 
  
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
Subjects Reporting Any Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Number of Treatment-Emergent Adverse Events 
xx 
xx 
xx 
xx 
Subjects Reporting Any Serious Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events 
xx 
xx 
xx 
xx 
Subjects Reporting Treatment-Emergent Adverse Event with Outcome of Fatal 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Number of Treatment-Emergent Adverse Events with Outcome of Fatal 
xx 
xx 
xx 
xx 
Subjects Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug xx 
xx 
xx 
xx 
Subjects Who Discontinued from the Study Due to a Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Number of Treatment-Emergent Adverse Events Leading to Discontinuation of Study 
xx 
xx 
xx 
xx 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
By subject denominator for each period includes the number of subjects in the safety population completing the period or experiencing an adverse 
event during the period. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.3.1: Summary of Treatment-Emergent Adverse Event Characteristics – By Period 
 (Safety Population) 
(Page 2 of 2) 
  
 0-12 Weeks 
 
(N=xxx)   
>12-28 Weeks 
 
(N=xxx)   
>28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
By Maximum Severity 
Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
By Strongest Relationship to Study Drug 
Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Maximum Severity within Relationship to Study Drug 
Related 
 Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related  
 Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
By subject denominator for each period includes the number of subjects in the safety population completing the period or experiencing an adverse 
event during the period. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.3.2: Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term – By Period 
(Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once. By subject denominator for each period includes the number of subjects in the safety population completing the  
period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.3.3: Summary of Treatment-Emergent Adverse Events by Severity – By Period 
 (Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
Severity 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once under the greatest reported reported severity. By subject denominator for each period includes the number of  
subjects in the safety population completing the period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
 
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.3.4: Summary of Treatment-Emergent Adverse Events by Relationship to Study Drug – By Period 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa  
Preferred Term  
 
Relationship 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once under the greatest reported relationship. By subject denominator for each period includes the number of  
subjects in the safety population completing the period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
 
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
 (Safety Population) 
(Page 1 of 2) 
  
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Subjects Reporting Any Serious Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events 
xx 
Subjects Reporting Serious Treatment-Emergent Adverse Event with Outcome of Fatal 
xx  ( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events with Outcome of Fatal 
xx 
Subjects Who Discontinued Study Drug Due to a Serious Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug 
xx 
Subjects Who Discontinued from the Study Due to a Serious Treatment-Emergent Adverse Event 
xx  ( xx.x%) 
Number of Serious Treatment-Emergent Adverse Events Leading to Discontinuation of Study 
xx 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics 
 (Safety Population) 
(Page 2 of 2) 
  
 
E-BPO 5% Cream 
 
(N=xxx)  
 
By Maximum Severity 
Severe 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
By Strongest Relationship to Study Drug 
Related 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
Maximum Severity within Relationship to Study Drug 
Related 
 Severe 
xx  ( xx.x%) 
 Moderate 
xx  ( xx.x%) 
 Mild 
xx  ( xx.x%) 
Not Related  
 Severe 
xx  ( xx.x%) 
 Moderate 
xx  ( xx.x%) 
 Mild 
xx  ( xx.x%) 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term 
(Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  
( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  
( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.3: Summary of Serious Treatment-Emergent Adverse Events by Severity 
 (Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
Severity 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( 
xx.x%) 
Moderate 
xx  ( 
xx.x%) 
Mild 
xx  ( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( 
xx.x%) 
Moderate 
xx  ( 
xx.x%) 
Mild 
xx  ( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class  
or 
Preferred Term) subjects are counted once under the greatest reported severity. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.4: Summary of Treatment-Emergent Serious Adverse Events by Relationship to Study Drug 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa  
Preferred Term  
 
Relationship 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( 
xx.x%) 
Not Related 
xx  ( 
xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( 
xx.x%) 
Not Related 
xx  ( 
xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once under the greatest reported relationship. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.5.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics – By Period 
 (Safety Population) 
(Page 1 of 2) 
  
 0-12 Weeks 
 
(N=xxx)   
>12-28 Weeks 
 (N=xxx)   
>28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
Subjects Reporting Any Serious Treatment-Emergent Adverse Event 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Number of Serious Treatment-Emergent Adverse Events 
xx 
xx 
xx 
xx 
Subjects Reporting Serious Treatment-Emergent Adverse Event with Outcome of Fatal 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Number of Serious Treatment-Emergent Adverse Events with Outcome of Fatal 
xx 
xx 
xx 
xx 
Subjects Who Discontinued Study Drug Due to a Serious Treatment-Emergent Adverse Event 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Number of Serious Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug xx 
xx 
xx 
xx 
Subjects Who Discontinued from the Study Due to a Serious Treatment-Emergent Adverse Event 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Number of Serious Treatment-Emergent Adverse Events Leading to Discontinuation of Study 
xx 
xx 
xx 
xx 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
By subject denominator for each period includes the number of subjects in the safety population completing the period or experiencing an adverse 
event during the period. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.5.1: Summary of Treatment-Emergent Serious Adverse Event Characteristics – By Period 
 (Safety Population) 
(Page 2 of 2) 
  
 0-12 Weeks 
 
(N=xxx)   
>12-28 Weeks 
 
(N=xxx)   
>28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
By Maximum Severity 
Severe 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Moderate 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Mild 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
By Strongest Relationship to Study Drug 
Related 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Not Related 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Maximum Severity within Relationship to Study Drug 
Related 
 Severe 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
 Moderate 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
 Mild 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
Not Related  
 Severe 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
 Moderate 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
 Mild 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
xx  (xx.x%) 
 
Note: Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
By subject denominator for each period includes the number of subjects in the safety population completing the period or experiencing an adverse 
event during the period. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.5.2: Summary of Treatment-Emergent Serious Adverse Events by MedDRA System Organ Class and Preferred Term – By Period 
(Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once. By subject denominator for each period includes the number of subjects in the safety population completing the  
period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.5.3: Summary of Treatment-Emergent Serious Adverse Events by Severity – By Period 
 (Safety Population) 
(Page 1 of x) 
  
System Organ Classa  
Preferred Term  
 
Severity 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Severe 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Moderate 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Mild 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once under the greatest reported reported severity. By subject denominator for each period includes the number of  
subjects in the safety population completing the period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
 
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.5.4: Summary of Treatment-Emergent Serious Adverse Events by Relationship to Study Drug – By Period 
(Safety Population) 
(Page 1 of xx) 
  
System Organ Classa  
Preferred Term  
 
Relationship 
 0-12 Weeks 
 
(N=xxx)   
 >12-28 Weeks 
 
(N=xxx)   
 >28-52 Weeks 
 
(N=xxx)   
 >52 Weeks 
 
(N=xxx)   
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxx 
Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
Not Related 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
xx  ( xx.x%) 
 
a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or  
Preferred Term) subjects are counted once under the greatest reported relationship. By subject denominator for each period includes the number of  
subjects in the safety population completing the period or experiencing an adverse event during the period. 
Note:  MedDRA Version 21.0. 
 
Treatment-emergent adverse events are those events with an onset after the first application of E-BPO 5% Cream. 
 
Related defined as “Definitely”, “Probably”, or “Possible”. Not Related defined as “Unlikely” or “Not related”. 
Periods defined from date of first dose of E-BPO 5% Cream. Period >52 Weeks includes all adverse events reported after week 52 through the end of  
 
study participation. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Vital Signs 
 (Safety Population) 
(Page 1 of 20) 
  
Temperature (°C) 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Baselinea 
 
n 
xxx 
Mean 
xx.x 
SD 
xx.xx 
Median 
xx.x 
Min. to Max. 
xx to xx 
Week 12b 
n 
xxx 
Mean 
xx.x 
SD 
xx.xx 
Median 
xx.x 
Min. to Max. 
xx to xx 
Change from Baseline 
 n 
xxx 
 Mean 
xx.x 
 SD 
xx.xx 
 Median 
xx.x 
 Min. to Max. 
xx to xx 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Negative change values represent decrease from Baseline. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Vital Signs 
 (Safety Population) 
(Page 2 of 20) 
  
Temperature (°C) 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 24b 
 
n 
xxx 
Mean 
xx.x 
SD 
xx.xx 
Median 
xx.x 
Min. to Max. 
xx to xx 
Change from Baseline 
 n 
xxx 
 Mean 
xx.x 
 SD 
xx.xx 
 Median 
xx.x 
 Min. to Max. 
xx to xx 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Negative change values represent decrease from Baseline. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Vital Signs 
 (Safety Population) 
(Page 3 of 20) 
  
Temperature (°C) 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 36b 
 
n 
xxx 
Mean 
xx.x 
SD 
xx.xx 
Median 
xx.x 
Min. to Max. 
xx to xx 
Change from Baseline 
 n 
xxx 
 Mean 
xx.x 
 SD 
xx.xx 
 Median 
xx.x 
 Min. to Max. 
xx to xx 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Negative change values represent decrease from Baseline. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
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CONFIDENTIAL 
 
Table 14.3.1.4.1: Summary of Vital Signs 
 (Safety Population) 
(Page 4 of 20) 
  
Temperature (°C) 
 
E-BPO 5% Cream 
 
(N=xxx)  
 
Week 48b 
 
n 
xxx 
Mean 
xx.x 
SD 
xx.xx 
Median 
xx.x 
Min. to Max. 
xx to xx 
Change from Baseline 
 n 
xxx 
 Mean 
xx.x 
 SD 
xx.xx 
 Median 
xx.x 
 Min. to Max. 
xx to xx 
 
a Baseline is defined as the baseline value from SGT-54-01/SGT-54-02. 
b Table summaries based analysis visits, representing time from first dose of E-BPO 5% Cream. 
Note: Negative change values represent decrease from Baseline. 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Repeat these pages for [Respiratory Rate (breaths/min), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg) and 
Heart Rate (beats/min)] 
 
 
 


 
 
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13. INDEX OF PLANNED LISTINGS 
Listing 16.1.7: Enrollment .............................................................................................................98 
Listing 16.2.1.1: End of Study Information ...................................................................................99 
Listing 16.2.2.1: Inclusion/Exclusion Criteria .............................................................................100 
Listing 16.2.2.2: Screen Failure ...................................................................................................101 
Listing 16.2.2.3: Protocol Deviations ..........................................................................................102 
Listing 16.2.3: Analysis Populations ...........................................................................................103 
Listing 16.2.4.1: Subject Demographic Information ...................................................................104 
Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................105 
Listing 16.2.4.2.2: Medical/Surgical History...............................................................................106 
Listing 16.2.4.3.1: Unique Medication Names Coded to WHO Drug Global Dictionary ATC 
Level 2 Terms and Preferred Names ...................................................107 
Listing 16.2.4.3.2: Prior and Concomitant Medications ..............................................................108 
Listing 16.2.4.4.1: Unique Procedure/Therapy Names Coded to MedDRA System Organ Classes 
and Preferred Terms ............................................................................109 
Listing 16.2.4.4.2: Prior and Concomitant Procedures/Therapies ...............................................110 
Listing 16.2.5.1: Study Visit Compliance ....................................................................................111 
Listing 16.2.5.2: Subject Dosing Compliance .............................................................................112 
Listing 16.2.5.3: Subject Dosing..................................................................................................113 
Listing 16.2.5.4: Study Medication Dispensation ........................................................................114 
Listing 16.2.5.5: Study Medication Accountability Log .............................................................115 
Listing 16.2.6.1: Investigator Global Assessment .......................................................................116 
Listing 16.2.6.2: Inflammatory Lesion Counts ............................................................................117 
Listing 16.2.6.3.1: RosaQoL Descriptions...................................................................................118 
Listing 16.2.6.3.1: RosaQoL Descriptions...................................................................................119 
Listing 16.2.6.3.2: RosaQoL ........................................................................................................120 
Listing 16.2.6.3.3: RosaQoL Subscales Scores ...........................................................................121 
Listing 16.2.6.4: Erythema Severity/Telangiectasia Assessments...............................................122 
Listing 16.2.7.1: Cutaneous Safety and Tolerability Assessments ..............................................123 


 
 
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Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and 
Preferred Terms ...................................................................................124 
Listing 16.2.7.2.2: Pre-Treatment Adverse Events ......................................................................125 
Listing 16.2.7.2.3: Treatment-Emergent Adverse Events ............................................................126 
Listing 16.2.7.2.4: Serious Adverse Events .................................................................................127 
Listing 16.2.7.2.5: Subjects Who Prematurely Discontinued Study and/or Discontinued Study 
Drug Due to Adverse Events...............................................................128 
Listing 16.2.8.1: Urine Pregnancy Tests ......................................................................................129 
Listing 16.2.8.2: Physical Examination .......................................................................................130 
Listing 16.2.8.3: Vital Signs ........................................................................................................131 


 
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Listing 16.1.7: Enrollment 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                  
Subject    Age/Sex   Eval         Enrollment Date        Date of Last Application       Prior Treatment From 
 
 
 
 
 
 
 
     From SGT-54-01/02 Study        SGT-54-01/02 Study 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx  
 
xxxxxx     xxxx      xxxxxxxxx    xxxxxxxxxxxxxxxx       xxxxxxxxxx                      xxxxxxx xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject. 
 
 


 
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Listing 16.2.1.1: End of Study Information 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                                      Date of Study 
                            Date of      Date of      Completion/      Did Subject                               
                            First        Last         Discontinuation  Complete     Primary Reason               
Subject  Age/Sex  Eval      Application  Application  (Day)1              the Study    for Study Discontinuation    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx     xxxxxxxx  xxxxxxxxxx   xxxxxxxxxx   xxxxxxxxxxxxxx   xxx                                        
                                                                                                                  
 
xxxxxx   xxxx     xxxxxxxx  xxxxxxxxxx   xxxxxxxxxx   xxxxxxxxxxxxxx   xx           xxxxxxx xxxxx                 
                                                                                                                  
 
xxxxxx   xxxx     xxxxxxxx  xxxxxxxxxx   xxxxxxxxxx   xxxxxxxxxxxxxx   xx           xxxx xx xxxxxxxxxx xxxxxxxxx xxxx xx xxxxxxxxxxx        
                                                                                     
                                                                                    xxxxx xxxxx xxxxx xxx xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date –  date of first application + 1 for dates on or after first application. 
   
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject. 
If Primary Reason for Study Discontinuation is Lost to Follow-Up, Protocol Violation, Withdrawal by Subject, or Other, the reason 
specification will be included following a colon (for example, WITHDRAWAL BY SUBJECT: xxxxx) 
 


 
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Listing 16.2.2.1: Inclusion/Exclusion Criteria  
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject     Age/Sex     Eval          Criterion Failed    Description 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxx              xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
xxxxxx      xxxx        xxxxxxxxx     xxxxx               xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
xxxxxx      xxxx        xxxxxxxxx     xxxxx               xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
                                      xxxxx               xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
                                      xxxxx               xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
                                                          xxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxxxxxxxxx xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Criterion Failed. 
 
 


 
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Listing 16.2.2.2: Screen Failure 
                                                             (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                         Date of    
Subject     Age/Sex     Eval          Screen Failure       Reason for Screen Failure 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx           xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx           xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxxxxxx           xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
                                      xxxxxxxxxx           xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
 
                                      xxxxxxxxxx           xxxxx xxx xx xxxxxxxx xxxx xxxxxxxxxxxxxxxxxxx xxxxxxxx  
                                                           xxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxxxxxxxxx xxx 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject. 
 
 


 
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Listing 16.2.2.3: Protocol Deviations 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject     Age/Sex     Eval          Deviation                                                                           Date (Day1)                  
______________________________________________________________________________________________________________________________________ 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxx x xxxxxxxx xxx xx xxxxxx xxxxxx xxx xxx xx xxxxxxxxxxxxx                  xxxxxxxxxxxxxxx 
 
                                      xxxxxx xxx xx xxxxxx xxxxxx xxx xxx xx                                           xxxxxxxxxxxxxxx 
 
                                      xxxxxx x xxxxxxxx  
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxx xxx xx xxxxxx xxxxxx xxx xxx xx                                           xxxxxxxxxxxxxxx 
 
xxxxxx      xxxx        xxxxxxxxx     xxxxxx xxx xx xxxxxx xxxxxx xxx xxx xx                                           xxxxxxxxxxxxxxx 
 
 
 
                                       
 
                                       
                                       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – Baseline visit date from SGT-54-07 for dates prior to Baseline visit. Otherwise, day is calculated as  
  date - Baseline date + 1 for dates on or after Baseline visit.   
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Date. 
 
 


 
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Listing 16.2.3: Analysis Populations 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Subject    Age/Sex     Population          Included   Reason(s) Excluded                      
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx        Safety              xxx 
 
xxxxxx     xxxx        Safety              xxx 
 
xxxxxx     xxxx        Safety              xx         xxxxxxxxxxx xxxxxxx xxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
Listing sorted by Subject and Population (as ordered above). 
 
 


 
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Listing 16.2.4.1: Subject Demographic Information 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                      B: Date of Birth                                                                                     
                      A: Age            R: Race                  C: Childbearing Potential              
Subject  Eval         S: Sex            E: Ethnicity             M: Method of Birth Control          Informed Consent Date     
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxxxxxxx    B: xxxx-xx-xx     R: xxxxxx xxxxxxxx       C: xxx                              xxxx-xx-xx 
                      A: xx                xx xxxxx xxxxxxx      M: xxxxxxxxx xxxxxxxxxx                
                      S: xxxxxx            xxxxxxxx xxxxxxxxxx      xxxxxxxxxxxxx xxxxxxxxxxx 
                                        E: xxx xxxxxxxx xx          xxxx x xxxxxxxxxx xx  
                                           xxxxxx                   xxxxxxxxx xxxxxxxxxx 
                                                                    xxxx xxxxxxx 
 
xxxxxx   xxxxxxxxx    B: xxxx-xx-xx      R: xxxxx                C: xx                               xxxx-xx-xx 
                      A: xx              E: xxxxxxxx xx xxxxxx   M:                                     
                      S: xxxx            
 
xxxxxx   xxxxxxxxx    B: xxxx-xx-xx      R: xxxxx                C: xxx                              xxxx-xx-xx 
                      A: xx              E: xxxxxxxx xx xxxxxx   M: xxxxxxxx xxxxxxxxxxxxx              
                      S: xxxxxx            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject. 
 
 


 
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Listing 16.2.4.2.1: Unique Medical/Surgical History Coded to MedDRA System Organ Classes and Preferred Terms 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                
MedDRA System Organ Class                     MedDRA Preferred Term                       Medical/Surgical History Verbatim Term 
______________________________________________________________________________________________________________________________________ 
 
xxxx xxx xxxxxxxxx xxxxxx xxxxxxxxx           xxxxxxx                                     xxxxxx 
 
                                              xxxx xxxxxxxxx xxxxxxxx                     xxxx xxxxxxxxxx xxxxxx 
 
xxxxxxxxxx xxx xxxxxxxxxxxx                   xxxxxxxxxxx                                 xxxxxxxxxxx 
 
                                              xxxxxxxxxxxxx                               xxxxxxxxxxxxx x xxxx xxx xxx 
                                                                    
                                                                                          xxxxxxxxxxxxx xx xxxxx xx xxxx xxxxx xxx 
                       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by System Organ Class, Preferred Term, and Verbatim Term. 
 
 


 
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Listing 16.2.4.2.2: Medical/Surgical History 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                               
                               Medical/Surgical History           S: MedDRA System Organ Class                     S: Onset Date 
Subject    Age/Sex   Eval      Verbatim Term                      P: MedDRA Preferred Term                         E: End Date 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx      xxxxxxxx  xxxxxxx                            S: xxxx xxx xxxxxxxxxxxx xxxxxx xxxxxxxxx        S: xxxx 
                                                                  P: xxxxxxx                                       E: 
 
                               xxxxxxx xx xxxxxxxxxxx xxxxxxxxx   S: xxxxxx xxxxxx xxxxxxxxx                       S: xxxx 
                                                                  P: xxxxxxxx xxxxx xxxxxxx                        E: xxxxxxx 
 
xxxxxx     xxxx      xxxxxxxx  xxxxxxx                            S: xxxx xxx xxxxxxxxxxxx xxxxxx xxxxxxxxx        S: xxxx 
                                                                  P: xxxxxxx                                       E: 
 
xxxxxx     xxxx      xxxxxxxx  xxxxxxx                            S: xxxx xxx xxxxxxxxxxxx xxxxxx xxxxxxxxx        S: xxxx 
                                                                  P: xxxxxxx                                       E: 
 
xxxxxx     xxxx      xxxxxxxx  xxxxxxx                            S: xxxx xxx xxxxxxxxxxxx xxxxxx xxxxxxxxx        S: xxxx 
                                                                  P: xxxxxxx                                       E: 
 
                               xxxxxxxxxxxxxxxx                   S: xxxxxx xxxxxx xxxx                            S: xxxxxxxxxx 
                                                                  P: xxxx xxxxxxxxxxx                              E: xxxxxxxx                         
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Rosacea Diagnosis (all Rosacea MH will appear first), Onset Date, End Date, Verbatim Term  
 
 


 
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Listing 16.2.4.3.1: Unique Medication Names Coded to WHO Drug Global Dictionary ATC Level 2 Terms and Preferred Names 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                               
                                                                                                  I: Indication 
WHO ATC Level 2 Term     WHO Preferred Name             Medication Verbatim Term                  T: Route 
_____________________________________________________________________________________________________________________________________ 
 
xxxxxxxxxxxxxx           xxxxxxxxxxxxxx                 xxxxxxxx                                  I: xxxxxxxxxxx 
                                                                                                  R: xxxxxxxxxxx 
 
                                                        xxxxxxxxx                                 I: xxxxxxxxxxx 
                                                                                                  R: xxxxxxxxxxx                                       
 
xxxxxxxxxxxxxx           xxxxxxxxxxxxxx                 xxxxxxxx                                  I: xxxxxxxxxxx 
                                                                                                  R: xxxxxxxxxxx 
 
                                                        xxxxxxxxx                                 I: xxxxxxxxxxx 
                                                                                                  R: xxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: ATC Level 2 Term and Preferred Name map to WHO Drug Global Dictionary, Format B3, Version March 1, 2018. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by ATC Level 2 Term, Preferred Name, Medication Verbatim Term, Indication, and Route. 
 
 


 
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Listing 16.2.4.3.2: Prior and Concomitant Medications 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                                                           
S: Subject   A: ATC Level 2 Term                                     S: Start Date (Day)¹   I: Indication 
A: Age/Sex   P: Preferred Name                                       E: End Date (Day)¹     D: Dose                 F: Frequency 
E: Eval      M: Medication Name                                      P: Prior/Concomitant   U: Units                T: Route    
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    A: xxxxxxxxxx xxx xxxxxxxxxxx                           S: xxxxxxxxxxxxxxx     I: xxxxxxx              F: xxx 
A: xxxx      P: xxxxxxxxxxx xxxxxxx xxxxxxxxxxxx xxx xxxxxxx xxx     E: xxxxxxxxxxxxxxx     D: xx                   T: xxxxxxxxxxxxxx 
E: xxxxxxxxx M: xxxxxx xxxxx xxxxxxxxx                               P: xxxxxxxxxxxxxxxxxxx U: xxxxxxxxxxx                                             
 
             A: xxxxxxxx xx xxxxxxxx                                 S: xxxxxxxxxxxxxxx     I: xxxxxxx              F: xx 
             P: xxxxxxxxxxx xxxxxxx xxx                              E: xxxxxxxxxxxxxxx     D: xx                   T: xxxxx 
             M: xxxxxx xxxxxxxxx                                     P: xxxxx 
         U: xxxxxxxx 
 
 
 
      
 
S: xxxxxx    A: xxxxxxxxxx xxx xxxxxxxxxxx                           S: xxxxxxxxxxxxxxx     I: xxxxxxx              F: xxx 
A: xxxx      P: xxxxxxxxxxx xxxxxxx xxxxxxxxxxxx xxx xxxxxxx xxx     E: xxxxxxxxxxxxxxx     D: xx                   T: xxxxxxxxxxxxxx 
E: xxxxxxxxx M: xxxxxx xxxxx xxxxxxxxx                               P: xxxxxxxxxxxxxxxxxxx U: xxxxxxxxxxx                                             
 
             A: xxxxxxxx xx xxxxxxxx                                 S: xxxxxxxxxxxxxxx     I: xxxxxxx              F: xx 
             P: xxxxxxxxxxx xxxxxxx xxx                              E: xxxxxxxxxxxxxxx     D: xx                   T: xxxxx 
             M: xxxxxx xxxxxxxxx                                     P: xxxxx 
         U: xxxxxxxx 
 
 
 
      
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date –  date of first application + 1 for dates on or after first application. 
 
Note: ATC Level 2 Term and Preferred Name map to WHO Drug Global Dictionary, Format B3, Version March 1, 2018. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Medication Name, Indication, Route, Frequency. If the Route is Topical, then the area 
treated is presented within parenthesis (T: Topical (specify area)). 
 


 
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Listing 16.2.4.4.1: Unique Procedure/Therapy Names Coded to MedDRA System Organ Classes and Preferred Terms 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
MedDRA System Organ Class         MedDRA Preferred Term             Procedure/Therapy Verbatim Term   Indication                       
______________________________________________________________________________________________________________________________________ 
 
xxxxxxxxxxxxxx                    xxxxxxxxxxxxxx                    xxxxxxxx  xx xxxxx                xxxxxxxxxxx 
                                                                                                   
                                                                    xxxxxxxxx                         xxxxx xx xxxx 
                                                                                                                                       
 
xxxxxxxxxxxxxx                    xxxxxxxxxxxxxx                    xxxxxxxx                          xxxxxxxx 
                                                                                                   
                                                                                                      xxxxxxxxxxx 
 
                                                                    xxxxxxxxx                         xxxxxxxxxxx 
                                                                                                       
xxxxx xxx xx xxxxxxx              xxxxxxx xxxxxxx xxxx              xxxxxxxx xxxxxx                   xxxxxxxx xxxxxxxx xx xx xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by System Organ Class, Preferred Term, Verbatim Term, and Indication. 
 
 


 
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Listing 16.2.4.4.2: Prior and Concomitant Procedures/Therapies 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                 S: MedDRA System Organ Class                  S: Start Date (Day)¹ 
                                 P: MedDRA Preferred Term                      E: End Date (Day)¹        I: Indication 
Subject    Age/Sex    Eval       M: Procedure/Therapy Name                     P: Prior/Concomitant      A: Anatomical Area Treated                    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx       xxxxxxxx   S: xxxxxxx xxx xxxxxxxx xxxxxxxxx             S: xxxxxxxxxxxxxxxxx      I: xxxxx xxxxxxx 
                                 P: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx           E: xxxxxxxxxxxxxxxxx      A: 
                                 M: xxxxxxx xxxxx xxxxxxx xxxxxxx              P: xxxxxxxxxxxxxxxxx 
 
xxxxxx     xxxx       xxxxxxxx   S: xxxxxxx xxx xxxxxxxx xxxxxxxxx             S: xxxxxxxxxxxxxxxxx      I: xxxxx xxxxxxx 
                                 P: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx           E: xxxxxxxxxxxxxxxxx      A: 
                                 M: xxxxxxx xxxxx xxxxxxx xxxxxxx              P: xxxxxxxxxxxxxxxxx 
 
xxxxxx     xxxx       xxxxxxxx   S: xxxxxxx xxx xxxxxxxx xxxxxxxxx             S: xxxxxxxxxxxxxxxxx      I: xxxxx xxxxxxx 
                                 P: xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx           E: xxxxxxxxxxxxxxxxx      A: 
                                 M: xxxxxxx xxxxx xxxxxxx xxxxxxx              P: xxxxxxxxxxxxxxxxx      
 
                                 S: xxxxxxx xxxxxxxx xxxx                      S: xxxxxxxxxxxxxxxxx      I: xxxxxxxxx xxxxx xx xx  
                                 P: xxx xxxxxxxxxx xxxxxxxx                    E: xxxxxxxxxxxxxxxxx      A: xxxxxxxxxx 
                                 M: xxxxxxx xxxxxxx                            P: xxxxxxxxxxxxxxxxx 
                                                                                
                                 S: xxxxxxx xxxxxxxx xxxx                      S: xxxxxxxxxxxxxxxxx      I: xxxxxxxxx xxxxx xx xx  
                                 P: xxx xxxxxxxxxx xxxxxxxx                    E: xxxxxxxxxxxxxxxxx      A: xxxxxxxxxx 
                                 M: xxxxxxx xxxxxxx                            P: xxxxxxxxxxxxxxxxx 
                                                                                
 
 
 
 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date –  date of first application + 1 for dates on or after first application. 
 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Procedure/Therapy Name, and Indication. 
 
 


 
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Listing 16.2.5.1: Study Visit Compliance 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
             
                                                                                           Reason Screening                                            
                                                                                  Within   And Baseline Visit       
                                         SGT-54-07          Visit                 Study    Occurred on            Reason for   
Subject  Age/Sex  Eval       Visit       Analysis Visit     Date         Day1     Window2  Different Days         Unscheduled Visit                    
______________________________________________________________________________________________________________________________________ 
 
xxxxxx    xxxx    xxxxxxxx   xxxxxxxxx   xxxxxxxxx          xxxxxxxxxx                       
                             xxxxxxxx    xxxx x             xxxxxxxxxx                     xxxxxxx xxx xx 
                             xxxx x      xxxx x             xxxxxxxxxx            
                             xxxx x      xxxx x             xxxxxxxxxx            
                             xxxx xx     xxxx x             xxxxxxxxxx            
                             xxxx xx     xxxx x             xxxxxxxxxx            
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx  
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xxxxx  xxxx x             xxxxxxxxxx    xx       xxx  
 
 
              xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx                            xxxxxxxxxxxxxx      
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
 
 
              xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx                            xxxxxxxxxxxxxx      
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
 
 
              xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx                            xxxxxxxxxxxxxx      
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                             xxxx xx     xxxx x             xxxxxxxxxx    xx       xxx 
                                 
                                  
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – Baseline  date from SGT-54-07 for dates prior to Baseline visit. Otherwise, day is calculated as  
  date - Baseline date + 1 for dates on or after Baseline visit. Day is only calculated for visits occurring in SGT-54-07. 
2 Determined by protocol-specified visit window for scheduled visits after Baseline. Only assessed for visits occurring in SGT-54-07.  
     
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number. 
 


 
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Listing 16.2.5.2: Subject Dosing Compliance 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                              
 
 
 
 
 
 
 
 
 
 
 
                Number of 
         Number of      
                                                             Number of             Total          Instructed            Non-Instructed  
                             Date of First  Date of Last     Days of              Number of         Missed                  Missed 
Subject  Age/Sex   Eval      Application    Application      Exposure                  Applications     Applications1          Applications2 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx      xxxxxxxx  xxxxxxxxxx     xxxxxxxxxx       xx                     xxx               xx                      xx              
  
xxxxxx   xxxx      xxxxxxxx  xxxxxxxxxx     xxxxxxxxxx       xx                     xxx               xx                      xx                       
 
xxxxxx   xxxx      xxxxxxxx  xxxxxxxxxx     xxxxxxxxxx       xx                     xxx               xx                      xx              
 
xxxxxx   xxxx      xxxxxxxx  xxxxxxxxxx     xxxxxxxxxx       xx                     xxx               xx                      xx              
 
xxxxxx   xxxx      xxxxxxxx  xxxxxxxxxx     xxxxxxxxxx       xx                     xxx               xx                      xx              
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
              
                                  
______________________________________________________________________________________________________________________________________ 
1 The number instructed missed applications is the total number of missed doses on the CRF with reason “Per PI Instruction”. 
2 The number of non-instructed missed applications is the total number of missed doses on the CRF with reason of “Other, specify    
  reason”. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject. 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 113 of 131  
CONFIDENTIAL 
Listing 16.2.5.3: Subject Dosing 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                          
                                                                                                 Number of Doses  
                                                                                                 Applied1 or Number  Reason Subject 
                                                                                                 Of Doses Applied    Did Not Dose        
                                                                                                 Each Day of the     or Dosed More  
Subject     Age/Sex     Eval        Study Interval                      Start Date   End Date    Date Span2          Than Once Per Day2 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx       xxxx       xxxxxxxx    54-01 First to Last Dose Interval  xxxxxxxxxx     xxxxxxxxxx                                                       
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                          
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                            
                                                                                              
xxxxxx       xxxx       xxxxxxxx    54-01 First to Last Dose Interval  xxxxxxxxxx     xxxxxxxxxx                                                       
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-01 Dosing Deviation             xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x  
                         
xxxxxx       xxxx       xxxxxxxx    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                          
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                          
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                            
                                    54-07 Dosing Interval              xxxxxxxxxx     xxxxxxxxxx  x                   xxx xx xxxxxxxxx      
 
______________________________________________________________________________________________________________________________________ 
1 From SGT-54-01 or SGT-54-02 
2 From SGT-54-7 
Note: Dosing from the SGT-54-01 or 54-02 study was pulled forward for only subject who received E-BPO 5% Cream in the Phase 3 study. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Start Date of Dosing Interval. 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 114 of 131  
CONFIDENTIAL 
Listing 16.2.5.4: Study Medication Dispensation 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                              
                                                                          Instructions Given to the Subject         Reason Why a New 
                                         Date of          Pump Number     by the Investiator Regarding              Pump Was Not 
Subject Age/Sex  Eval        Visit      Dispensation       Assigned        When to Apply the Study Product           Dispensed 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx    xxxxxxxx    xxxxxxxx   xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xx xxxx  xxxxxxx xx x x xxxxxx xx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxx xxxxxxxxxx  xxxx xx x x xxxx xx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxx x xxx  
                             xxxx x     xxxxxxxxxx        xxxx           xxxx xx xxxx  xxxxxxx xx x x xxxxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           x xxxxx xxx xx  
                             xxxx x     xxxxxxxxxx        xxxx              
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxxx           
 
xxxxxx   xxxx    xxxxxxxx    xxxxxxxx   xxxxxxxxxx        xxxx           xxxxxxx  xxxx xx x x xxxx xxxx          
                             xxxx x     xxxxxxxxxx        xxxx           xx xxxx  xxxxxxx xx x x xxxxxx xxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxx x xxx  
                             xxxx x     xxxxxxxxxx        xxxx           xxxx xx xxxx  xxxxxxx xx x x xxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxxx x xxxxx xxx xx  
                             xxxx x     xxxxxxxxxx        xxxx              
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxx xx xxxx  xxxxxxx xx x x xxxxxxx           
                             xxxx x     xxxxxxxx                                                                       x xxxxx xxxxx  
                                                                                                                       xxxxxxxxx xx  
                                                                                                                       xxx x xxx xxx      
                             xxxx x     xxxxxxxxxx        xxxx           xxxx xx xxxx   
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           xxxx xx xxxx  xxxxxxx xx x x xxxxxx xxxxxx           
                             xxxx x     xxxxxxxxxx        xxxx           x xxxxx xxx xx  
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxx xxxxx xx x x xxxxx xxxx xxx xxxx    
                             xxxx x     xxxxxxxxxx        xxxx           xxxxxxxxxx  xxxx xx x x xxxx xxxxxx           
 
 
 
               
                                  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Note to programmers: If a pump was not dispensed, NOT DONE will print in the date column. Listing sorted by Subject and Visit Number. 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 115 of 131  
CONFIDENTIAL 
Listing 16.2.5.5: Study Medication Accountability Log 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                        
                            Pump      ______Dispensing______    ________Return________    Amount    
Subject Age/Sex  Eval       Number    Date        Weight (g)    Date        Weight (g)    Used (g)  
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx    xxxxxxxx   xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxx           xxxxxxxxxx  xxxx          xxxx     
 
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxx xxxx                  xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
 
xxxxxx   xxxx    xxxxxxxx   xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxx xxxx 
 
 
 
 
 
                        
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx 
 
 
xxxxxx   xxxx    xxxxxxxx   xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx     
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx                
                            xxxx       xxxxxxxxxx  xxxx          xxxxxxxxxx  xxxx          xxxx                    
 
 
 
 
 
 
 
 
 
 
 
               
                                  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 116 of 131  
CONFIDENTIAL 
Listing 16.2.6.1: Investigator Global Assessment 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                   SGT-54-07         Date of      Evaluator 
Subject      Age/Sex     Eval          Visit       Analysis Visit    Assessment   Initials        Result                           
______________________________________________________________________________________________________________________________________ 
 
xxxxxx        xxxx       xxxxxxxx      xxxxxxxxx   xxxxxxxxx         xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx x      xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx x      xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xxxxx  xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                          
 
xxxxxx        xxxx       xxxxxxxx      xxxxxxxxx   xxxxxxxxx         xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx x      xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx x      xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xx     xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                         
                                       xxxx xxxxx  xxxx x            xxxxxxxxxx    xxx             xxxxxxxxxx                          
 
 
 
 
 
 
 
               
                                  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 117 of 131  
CONFIDENTIAL 
Listing 16.2.6.2: Inflammatory Lesion Counts 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                                                                              Total 
                                          SGT-54-07         Date of      Evaluator                          Inflammatory     Nodules/        
Subject  Age/Sex  Eval       Visit        Analysis Visit    Assessment   Initials     Papules     Pustules   Lesion Count     Cysts 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx     xxxx   xxxxxxxx   xxxxxxxxx    xxxxxxxxx        xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx x       xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx x       xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xxxxx   xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
 
xxxxxx     xxxx   xxxxxxxx   xxxxxxxxx    xxxxxxxxx        xxxxxxxxxx      xxx           xx          xx           xx             x 
                              
xxxxxx     xxxx   xxxxxxxx   xxxxxxxxx    xxxxxxxxx        xxxxxxxxxx      xxx           xx          xx           xx             x 
 
xxxxxx     xxxx   xxxxxxxx   xxxxxxxxx    xxxxxxxxx        xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx x       xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx x       xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xx      xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
                             xxxx xxxxx   xxxx x           xxxxxxxxxx      xxx           xx          xx           xx             x 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 118 of 131  
CONFIDENTIAL 
Listing 16.2.6.3.1: RosaQoL Descriptions 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Number     RosaQoL Question 
______________________________________________________________________________________________________________________________________ 
 
1          I worry that my rosacea may be serious 
 
2          My rosacea burns or stings 
 
3          I worry about getting scars from my rosacea 
 
4          I worry that my rosacea may get worse 
 
5          I worry about side effects from rosacea medications 
 
6          My rosacea is irritated 
 
7          I am embarrassed by my rosacea 
 
8          I am frustrated by my rosacea 
 
9          My rosacea makes my skin sensitive 
 
10         I am annoyed by my rosacea 
 
11         I am bothered by the appearance of my skin (redness, blotchiness) 
 
12         My rosacea makes me feel self-conscious 
 
13         I try to cover up my rosacea (with make-up) 
 
14         I am bothered by persistence/reoccurrence of my rosacea 
 
15         I avoid certain foods or drinks because of my rosacea 
              
16         My skin feels bumpy (uneven, not smooth, irregular)                                  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 119 of 131  
CONFIDENTIAL 
Listing 16.2.6.3.1: RosaQoL Descriptions 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
Number     RosaQoL Question 
______________________________________________________________________________________________________________________________________ 
 
17         My skin flushes 
 
18         My skin gets irritated easily (cosmetics, aftershaves, cleansers) 
 
19         My eyes bother me (feels dry or gritty) 
 
20         I think about my rosacea 
 
21         I avoid certain environments (heat, humidity, cold) because of my rosacea 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 120 of 131  
CONFIDENTIAL 
Listing 16.2.6.3.2: RosaQoL 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
S: Subject 
A: Age/Sex              SGT-54-07       Date of 
E: Eval       Visit    Analysis Visit  Assessment   1   2   3   4   5   6   7   8   9  10  11  12  13  14  15  16  17  18  19  20  21 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
A: xxx      
E: x               
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
 
S: xxxxxx    xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
A: xxx      
E: x               
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
 
S: xxxxxx    xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
A: xxx      
E: x               
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
             xxxxxxxx  xxxxxxxxxx      xxxxxxxxxx   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x   x  x   x   x 
 
______________________________________________________________________________________________________________________________________ 
1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = All the time; ND = Not Done 
Note: Full RosaQoL question text is available in Listing 16.2.6.3.1. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 121 of 131  
CONFIDENTIAL 
Listing 16.2.6.3.3: RosaQoL Subscales Scores 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
 
                                      SGT-54-07         Date of      
Subject  Age/Sex  Eval      Visit     Analysis Visit   Assessment    Total Score1      Symptom2        Functional3           Emotional4 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxxx    xxxxxxxx  xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
 
xxxxxx   xxxxx    xxxxxxxx  xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
 
xxxxxx   xxxxx    xxxxxxxx  xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
 
xxxxxx   xxxxx    xxxxxxxx  xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
 
xxxxxx   xxxxx    xxxxxxxx  xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
                            xxxxxxxxxx xxxxxxxxxx      xxxxxxxxxx      xx                xx              xx                 xx 
 
 
______________________________________________________________________________________________________________________________________ 
1 Total Score calculated from the unweighted mean of all RosaQoL questions. 
2 Symptom Subscale Score calculated from items 2, 6, 9, 16, 17, 18, and 19. 
3 Functional Subscale Score calculated from items 13, 15, and 21. 
4 Emotional Subscale Score calculated from items 1, 3, 4, 5, 7, 8, 10, 11, 12, 14, and 20. 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 122 of 131  
CONFIDENTIAL 
Listing 16.2.6.4: Erythema Severity/Telangiectasia Assessments 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                   SGT-54-07        Date of         Evaluator                                
Subject      Age/Sex     Eval          Visit       Analysis Visit   Assessment      Initials         Assessment            Result  
______________________________________________________________________________________________________________________________________ 
 
xxxxxx        xxxx       xxxxxxxx      xxxxxxxxx    xxxxxxxxx       xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx  
    
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
 
                                       xxxx x       xxxx x          xxxxxxxxxx      xxx              Rosacea Erythema      xxxxxxxxxx             
                                                                                                     Telangiectasia        xxxxxxxxxx 
                                                                        
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number, and Assessment (in order presented on eCRF). 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 123 of 131  
CONFIDENTIAL 
Listing 16.2.7.1: Cutaneous Safety and Tolerability Assessments 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                            SGT-54-07        Date of       Evaluator                                            
Subject  Age/Sex  Eval          Visit       Analysis Visit   Assessment    Initials      Test                          Result      
______________________________________________________________________________________________________________________________________ 
 
xxxxxx    xxxx    xxxxxxxx      xxxxxxxxx   xxxxxxxxx        xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
                                                                           
                                xxxx x      xxxx x           xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
                                      
                                xxxx x      xxxx x           xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
 
                                xxxx x      xxxx x           xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
                                  
                                xxxx x      xxxx x           xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
                                xxxx x      xxxx x           xxxxxxxxxx     xxx          Dryness                       xxxxxxxx          
                                                                                         Scaling                       xxx xxxx                  
                                                                                         Itching                       xxxxxxxxxxxx    
                                                                                         Burning/Stinging              xxxxxxxxxxx 
 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit Number, and Test (in order presented on eCRF). 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 124 of 131  
CONFIDENTIAL 
Listing 16.2.7.2.1: Unique Adverse Events Coded to MedDRA System Organ Classes and Preferred Terms 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                                              Application 
MedDRA System Organ Class                 MedDRA Preferred Term               Area           Adverse Event   
______________________________________________________________________________________________________________________________________ 
 
xxxxxxx xxxxxxxxx xxx xxxxxxxxxxxxxxx     xxxxxxxxxx xxx xxxxxxxxxxxxxxxx     xxx            xxxxxxxxxxxx xxxxxxxx xx xx xxxxxx 
                                                                               
                                                                              xx             xxxxxxxx 
                                                                             
                                                                              xx             xxxxx xxxxxxxx 
 
                                          xxxxxxxxx                           xx             xxxxxxxx 
 
xxxxxx xxxxxx xxxxxxxxx                   xxxxxxxx                            xx             xxxxxxx 
 
xxxx xxx xxxxxxxxxxxx xxxxxx xxxxxxxxx    xxxxxxx                             xxx            xxxxxxxxx xx xxxxxxx     
     
                                          xxxx xxxxxxxxxxx                    xx             xxxxxxx xxxx xxxxxxxxx xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
                                  
______________________________________________________________________________________________________________________________________ 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by System Organ Class, Preferred Term, Adverse Event. 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 125 of 131  
CONFIDENTIAL 
Listing 16.2.7.2.2: Pre-Treatment Adverse Events 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                   A: In the Application Area 
S: Subject   S: MedDRA System Organ Class          G: Severity                   A: Action Taken with Study Drug  
A: Age/Sex   P: MedDRA Preferred Term              R: Relationship to Study Drug T: Action Taken to Treat Event  S: Start Date (Day)¹ 
E: Eval      A: Adverse Event                      S: Serious Event              O: Outcome                      E: End Date (Day)¹ 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    S: xxxx xxx xxxxxxxxxxxx xxxxxx       A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx  
A: xxxx      P: xxx xxxxxxxxxxx                    G: xxxx                       T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxx xxxx xxxxxxxxx xxxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                         
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                         
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxxxxxx                    O: xxxxxxxxxxxxxxxxxx            
                                                   S: xxx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                                                 
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date – date of first application + 1 for dates on or after first application. 
 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Adverse Event. 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
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CONFIDENTIAL 
Listing 16.2.7.2.3: Treatment-Emergent Adverse Events 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                   A: In the Application Area 
S: Subject   S: MedDRA System Organ Class          G: Severity                   A: Action Taken with Study Drug  
A: Age/Sex   P: MedDRA Preferred Term              R: Relationship to Study Drug T: Action Taken to Treat Event  S: Start Date (Day)¹ 
E: Eval      A: Adverse Event                      S: Serious Event              O: Outcome                      E: End Date (Day)¹ 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    S: xxxx xxx xxxxxxxxxxxx xxxxxx       A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx  
A: xxxx      P: xxx xxxxxxxxxxx                    G: xxxx                       T: xxxx                         E: xxxxxxxxxxxxxxx  
E: xxxxxxxx  A: xxxxxxx xxxx xxxxxxxxx xxxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                         
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xxx                         
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
                                                   S: xxx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxxxxxx                    O: xxxxxxxxxxxxxxxxxx            
                                                   S: xx                                     
                                      
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date – date of first application + 1 for dates on or after first application. 
 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Adverse Event. 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 127 of 131  
CONFIDENTIAL 
Listing 16.2.7.2.4: Serious Adverse Events 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
             S: MedDRA System Organ Class                       
             P: MedDRA Preferred Term              A: In the Application Area 
S: Subject   A: Adverse Event                      G: Severity                   A: Action Taken with Study Drug  
A: Age/Sex   O: Occurred Prior to First            R: Relationship to Study Drug T: Action Taken to Treat Event  S: Start Date (Day)¹ 
E: Eval         Application                        S: Serious Event              O: Outcome                      E: End Date (Day)¹ 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    S: xxxx xxx xxxxxxxxxxxx xxxxxx       A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxx xxxxxxxxxxx                    G: xxxx                       T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxx xxxx xxxxxxxxx xxxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxxxxxx                    O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
 
 
 
 
 
 
 
 
                                      
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date – date of first application + 1 for dates on or after first application. 
 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Adverse Event. 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 128 of 131  
CONFIDENTIAL 
Listing 16.2.7.2.5: Subjects Who Prematurely Discontinued Study and/or Discontinued Study Drug Due to Adverse Events 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                                                                                       
             S: MedDRA System Organ Class                       
             P: MedDRA Preferred Term              A: In the Application Area 
S: Subject   A: Adverse Event                      G: Severity                   A: Action Taken with Study Drug  
A: Age/Sex   O: Occurred Prior to First            R: Relationship to Study Drug T: Action Taken to Treat Event  S: Start Date (Day)¹ 
E: Eval         Application                        S: Serious Event              O: Outcome                      E: End Date (Day)¹ 
______________________________________________________________________________________________________________________________________ 
 
S: xxxxxx    S: xxxx xxx xxxxxxxxxxxx xxxxxx       A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxx xxxxxxxxxxx                    G: xxxx                       T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxx xxxx xxxxxxxxx xxxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
             S: xxxxxxx xxxxxxxxx xxx xxxxxxxxx    A: xxx                        A: xxx xxxxxxxxxx               S: xxxxxxxxxxxxxxx 
             P: xxxxxxxxxx                         G: xxxx                       T: xxxxxxxxxxxx xxxxxxxxxx      E: xxxxxxxxxxxxxxx 
             A: xxxxxxxx xxxxx xxxxxxxx xxxx       R: xxx xxxxxxx                O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
 
S: xxxxxx    S: xxxx xxxxxxxxx xxxxxx              A: xx                         A: xxx xx xxxxxxx               S: xxxxxxxxxxxxxxx 
A: xxxx      P: xxxxxxxxx                          G: xxxxxxxx                   T: xxxx                         E: xxxxxxxxxxxxxxx 
E: xxxxxxxx  A: xxxxxxxxx xxxxx                    R: xxxxxxx                    O: xxxxxxxxxxxxxxxxxx            
             O: xx                                 S: xxx                         
 
 
 
 
 
 
 
 
 
                                      
______________________________________________________________________________________________________________________________________ 
¹ Day is calculated as date – date of first application of E-BPO 5% Cream (from SGT-54-01/SGT-54-02 or SGT-54-07) for dates prior to  
  first application. Otherwise, day is calculated as date –  date of first application + 1 for dates on or after first application. 
 
Note: System Organ Class and Preferred Term map to MedDRA (Version 21.0). 
 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Start Date, End Date, Adverse Event. 
 
 


 
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CONFIDENTIAL 
Listing 16.2.8.1: Urine Pregnancy Tests  
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
Subject  Age/Sex  Eval          Visit                   Date of Assessment          Results        Reason Test Not Done                       
______________________________________________________________________________________________________________________________________ 
 
xxxxxx    xxxx    xxxxxxxx      xxxxxxxxx               xxxxxxxxxx                 xxxxxxxx   
                                xxxxxxxx                xxxxxxxxxx                 xxxxxxxx           
                                xxxx x                                                              xxx xxxx  
                                xxxx x                  xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                                                                                                                                      
xxx        xxxx    xxxxxxxx     xxxxxxxxx               xxxxxxxxxx                 xxxxxxxx 
                                xxxxxxxx                xxxxxxxxxx                 xxxxxxxx           
                                xxxx x                  xxxxxxxxxx                 xxxxxxxx 
                                xxxx x                  xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx      
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                                                       
xxx        xxxx    xxxxxxxx     xxxxxxxxx                                                          xxx xxxxxxxxxx  
                                xxxxxxxxx                                                          xxx xxxxxxxxxx 
                                xxxx x                                                             xxx xxxxxxxxxx 
                                xxxx x                                                             xxx xxxxxxxxxx 
                                xxxx xx                                                            xxx xxxxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                xxxx xx                 xxxxxxxxxx                 xxxxxxxx 
                                 
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject and Visit Number. 
 
 


 
TOOL.AN.10-01.01 Statistical Analysis Plan Template 
Page 130 of 131  
CONFIDENTIAL 
Listing 16.2.8.2: Physical Examination 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                    Date of                                                              Reason Exam 
Subject Age/Sex  Eval       Visit                   Assessment  Body System                  Exam Finding                Not Done                      
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx    xxxxxxxx   xxxxxxxx                xxxxxxxxxx  xxxxx                        xxxxxx 
                                                                xxxx                         xxxxxx 
                                                                xxxxxxx                      xxxxxx 
                                                                xxxxxxxxxxxxxx               xxxxxxxxx xxxxxxxxx xxxx  
                                                                xxxxxxxxxxxxxxxxxxxxxxxxx    xxxxxx xxxxx xxxx xxx 
                                                                xxxxxxxxx                    xxxxxxxxx xx xxxx xxxxxx  
  
                            xxxx xxxxx              xxxxxxxxxx  xxxxx  
                                                                xxxx             
                                                                xxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx                 
 
xxxxxx   xxxx    xxxxxxxx   xxxxxxxx                xxxxxxxxxx  xxxxx                        xxxxxx 
                                                                xxxx                         xxxxxx 
                                                                xxxxxxx                      xxxxxx 
                                                                xxxxxxxxxxxxxx               xxxxxxxxx xxxxxxxxx xxxx  
                                                                xxxxxxxxxxxxxxxxxxxxxxxxx    xxxxxx xxxxx xxxx xxx 
                                                                xxxxxxxxx                    xxxxxxxxx xx xxxx xxxxxx  
  
                            xxxx xxxxx              xxxxxxxxxx  xxxxx  
                                                                xxxx             
                                                                xxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx 
                                                                xxxxxxxxxxxxxx                xxx xxxx                  xxx xxxxxxxxxx                 
 
 
 
                                  
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit Number, and Body System (in order presented on eCRF). 
 
 


 
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CONFIDENTIAL 
Listing 16.2.8.3: Vital Signs 
                                                            (Page xx of yy) 
 
______________________________________________________________________________________________________________________________________ 
                                                                                         
                                                    Date of                                                                                  
Subject Age/Sex  Eval       Visit                   Assessment  Vital Sign                  Result                       Units 
______________________________________________________________________________________________________________________________________ 
 
xxxxxx   xxxx    xxxxxxxx   xxxxxxxx                xxxxxxxxxx  xxxxxxxxx xxxxx xxxxxxxx    xx                           xxxx  
                                                                xxxxx xxxx                  xx                           xxxxxxxxx  
                                                                xxxxxx                      xxxxx                        xx   
                                                                xxxxxxxxxxx xxxx            xx                           xxxxxxxxxxx 
                                                                xxxxxxxx xxxxx xxxxxxxx     xxx                          xxxx 
                                                                xxxxxxxxxxx                 xxxx                         x    
                                                                xxxxxx                      xxx                          xx 
  
                            xxxx xxxxx              xxxxxxxxxx  xxxxxxxxx xxxxx xxxxxxxx    xx                           xxxx 
                                                                xxxxx xxxx                  xxx xxxx    
                                                                xxxxxxxxxxx xxxx            xxx                          xxxxxxxxxxx   
                                                                xxxxxxxx xxxxx xxxxxxxx     xxx                          xxxx 
                                                                xxxxxxxxxxx                 xx                           x 
                                                              
xxxxxx   xxxx    xxxxxxxx   xxxxxxxx                xxxxxxxxxx  xxxxxxxxx xxxxx xxxxxxxx    xx                           xxxx 
                                                                xxxxx xxxx                  xx                           xxxxxxxxx  
                                                                xxxxxx                      xxx                          xx 
                                                                xxxxxxxxxxx xxxx            xx                           xxxxxxxxxxx 
                                                                xxxxxxxx xxxxx xxxxxxxx     xx                           xxxx 
                                                                xxxxxxxxxxx                 xx                           x 
                                                                xxxxxx                      xxx                          xx                
 
                            xxxx xxxxx              xxxxxxxxxx  xxxxxxxxx xxxxx xxxxxxxx    xxx xxxx 
                                                                xxxxx xxxx                  xxx xxxx    
                                                                xxxxxxxxxxx xxxx            xxx xxxx 
                                                                xxxxxxxx xxxxx xxxxxxxx     xxx xxxx  
                                                                xxxxxxxxxxx                 xxx xxxx                                                   
______________________________________________________________________________________________________________________________________ 
SOURCE: USERNAME\SPONSOR\PROJECT\JOBNAME (DATE, TIME) 
 
Listing sorted by Subject, Visit Number, and Vital Sign (in alphabetical order).