Conditions: Scalp Psoriasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: yes

Brief summary:
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis

Detailed description:
* Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
* Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Arms:
arm 1: treatment with DSXS once daily for 28 days

Interventions: intervention 1: DSXS topical product
Intervention descriptions: intervention 1: treatment daily for 28 days

Protocol document:
Prot_000.pdf: 
CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 1 of 48 
 
 
 
1.0 TITLE PAGE 
 
 
 
 
 
 
 
This document is a confidential communication of Novum Pharmaceutical Research Services.  Receipt of 
this document constitutes an agreement by the recipient that no unpublished information contained herein 
will be disclosed without Novum's written approval. 
 
 
Drug Product 
Desoximetasone 0.25% Shampoo, w/w 
 
Design 
An open-label, safety study to assess the potential for adrenal 
suppression following maximal use treatment with desoximetasone 
0.25% shampoo applied once-daily in patients with moderate to 
severe scalp psoriasis 
 
Population 
Up to 5-10 patients 12-17 years of age with a confirmed diagnosis 
of moderate to severe scalp psoriasis with ≥ 20% scalp affected. 
 
Sponsor 
Taro Pharmaceuticals U.S.A., Inc. 
3 Skyline Drive 
Hawthorne, NY 10532 
 
Protocol Number 
DSXS 1538b  
 
Novum Study Number 
71615001 
 
IND # 
 
124879 
Protocol Date 
Protocol Rev 1 Date 
04/18/2016 
06/28/2016 
 
NIIRB 
July 05, 2016 
APPROVED 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 2 of 48 
 
 
 
2.0 KEY STUDY PERSONNEL AND FACILITIES 
 
Sponsor: 
 
Taro Pharmaceuticals U.S.A., Inc. 
3 Skyline Drive 
Hawthorne, NY 10532 
 
 
CRO: 
 
Novum Pharmaceutical Research Services (Novum) 
225 W. Station Square Drive, Suite 200 
Pittsburgh, PA 15219 
 
 
Sponsor’s Representative: 
 
Natalie Yantovskiy 
Senior Director, Clinical Research 
Taro Pharmaceuticals U.S.A., Inc. 
Phone: 914-345-9001 Ext 6849 
Fax: 914-593-0078 
Email: Natalie.Yantovskiy@Taro.com 
 
 
CRO representative 
 
Gail Gongas 
Vice President, Clinical Trials 
Novum Pharmaceutical Research Services 
Tel: 412-363-3300 x 522 
Fax: 412-924-0522 
Email: gdgongas@novumprs.com 
 
 
Medical Monitor: 
 
Paolo Fanzio, MD 
Medical Monitor 
Novum Pharmaceutical Research Services 
Tel: 412-363-3300 x 597 
Fax: 412-291-3171 
Email: pmfanzio@novumprs.com 
 
 
Biostatistician: 
 
Jianhua Liu, MSc 
Senior Biostatistician 
Novum Pharmaceutical Research Services 
Tel: 647-779-6883 
Email: jliu@novumprs.com 
 
 
 
 
 


-.w·. 
CONFlDI•:NTTAI, PROTOCOL 
i\11 Open Label, Safety Study to Assess the Potcntiul tor Ad1·cnal Suppression Following Maximal Ust• Trcatmt·nt 
with D~soximetnsonc 0.?5'% shampoo(Taro Pharmneeuticals U.S.A., Inc.) in Patients with Scalp l'soriasi!; 
SIGNATtJJ.m PAGE 
We, the undersigned, have emcf"ully 1·ead this protocol and agree thai it contains all the necessary 
inf<mnation required to conduct the study. The study will be perfonncd accot·ding to this protocol, 
all applicable l1Di\ regulations, ICH guidelines 11nd Good Clinicol l)rncticc 5tandards. 
CJail Ciongas 
Vice President, Clinical Trials 
Novum Pharmace.utical Research Setviccs 
4~~¥"'~:fj?:~ ~-. . 
~ ~---······· 
l'fi\llo 1-a,{;;,,, tv1D 
~kdiL:n( Monitor 
Novum Pharnwccutical Research Services 
l<eith D. Gallicano, PhD 
Vice Prcsiclcnt, Scientific AfTuirs 
Novum PhamlaCctllical Res,~nrch Services 
A! YD.n Iars ft; 
Natalie Yantovskiy 
Senior DircGtor, Clinical Rl~search 
Taro l>lwrnHlccuticnl U.S.A., Inc. 
Date 
<>t (;:).!.:,(,;_~I~ 
···--·-···-·-·····. 
··········· . -·-·-···-
Uate 
2016.07.27 18:05:26 -04'00' 
71615001 Rev, 1,. Jun<: 2S, 2016 "' Taro Phnrnwccuticals U.S.i\.,lllc" Pag\~ :l of4S 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 4 of 48 
 
 
 
PRINCIPAL INVESTIGATOR’S SIGNATURE 
 
 
 
I _______________________________________, agree to conduct protocol DSXS 1538b Rev 1 in 
accordance with FDA regulations, ICH guidelines and Good Clinical Practice. I understand that no 
deviations from the protocol may be made without the prior permission of the Sponsor (Taro 
Pharmaceuticals, U.S.A.) or Novum Pharmaceutical Research Services, the company managing the study. 
 
 
 
 
 
___________________________________ 
 
 
           __________ 
Principal Investigator 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 5 of 48 
 
 
 
 
3.0 TABLE OF CONTENTS 
 
1.0 TITLE PAGE .......................................................................................................................................... 1 
2.0 KEY STUDY PERSONNEL AND FACILITIES .................................................................................. 2 
SIGNATURE PAGE .................................................................................................................................... 3 
3.0 TABLE OF CONTENTS ........................................................................................................................ 5 
4.0 SYNOPSIS .............................................................................................................................................. 8 
5.0 STUDY SCHEMATIC ......................................................................................................................... 13 
6.0 LIST OF ABBREVIATIONS AND TERMS ....................................................................................... 14 
7.0 INTRODUCTION ................................................................................................................................ 15 
7.1 Disease Being Treated ...................................................................................................................... 15 
7.2 Availability and Efficacy of Already Approved Therapies .............................................................. 15 
7.3 Scientific and Statistical Considerations ........................................................................................... 16 
7.4 Risks and Benefits ............................................................................................................................. 16 
8.0 STUDY OBJECTIVES ......................................................................................................................... 17 
9.0 INVESTIGATIONAL PLAN ............................................................................................................... 17 
9.1 Study Design and Plan Description .................................................................................................. 17 
9.2 Selection of Study Design ................................................................................................................. 18 
9.3 Selection of Study Population ........................................................................................................... 18 
9.3.1 Inclusion Criteria........................................................................................................................ 18 
9.3.2 Exclusion Criteria ...................................................................................................................... 18 
9.3.3 Restrictions during the Study ..................................................................................................... 20 
9.3.4 Removal of Patients from the Study .......................................................................................... 21 
9.4 Treatments......................................................................................................................................... 22 
9.4.1 Treatments Administration ........................................................................................................ 22 
9.4.2 Identity of Investigational Product ............................................................................................. 23 
9.4.3 Method of Assigning Patients to Treatment Groups .................................................................. 23 
9.4.4 Packaging ................................................................................................................................... 23 
9.4.5 Accountability ............................................................................................................................ 23 
9.5 Study Conduct ................................................................................................................................... 23 
9.5.1 Visit 1: Screening/Enrollment (Day 1), before 12 pm ............................................................... 23 
9.5.2 Visit 2 (Day 14 ± 2): Interim Visit ............................................................................................. 24 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 6 of 48 
 
 
 
9.5.3 Visit 3 (Day 29 ± 2): End of Study or Early Termination, Before 12 pm .................................. 25 
9.5.4 Visit 4 (Day 42 ± 4): Follow-up Phone Call .............................................................................. 26 
9.6 Study Procedures .............................................................................................................................. 26 
9.6.1 Informed Consent/Assent ........................................................................................................... 26 
9.6.2 Demographics ............................................................................................................................ 26 
9.6.3 Medical History ......................................................................................................................... 26 
9.6.4 Vital Signs .................................................................................................................................. 26 
9.6.5 Physical Exam ............................................................................................................................ 26 
9.6.6 HEENT Exam ............................................................................................................................ 26 
9.6.7 Percent Scalp Affected ............................................................................................................... 27 
9.6.8 Investigator Global Assessment ................................................................................................. 27 
9.6.9 Ocular Discomfort Assessment .................................................................................................. 27 
9.6.10 Concomitant Medication Use ................................................................................................... 27 
9.6.11 Pregnancy Test ......................................................................................................................... 27 
9.6.12 Dispensing Study Product ........................................................................................................ 27 
9.6.13 Collecting Study Product ......................................................................................................... 27 
9.6.14 Dosing Instructions and Diary ................................................................................................. 28 
9.6.15 Dosing Compliance .................................................................................................................. 28 
9.6.16 Patient Wristband ..................................................................................................................... 28 
9.6.17 Laboratory Evaluation.............................................................................................................. 28 
9.6.18 Cortisol Response Test............................................................................................................. 28 
9.7 Adverse Events ................................................................................................................................. 30 
9.7.1 Adverse Event Definitions ......................................................................................................... 30 
9.7.2 Severity of Adverse Event ......................................................................................................... 30 
9.7.3 Relationship of Adverse Event .................................................................................................. 30 
9.7.4 Patient’s Participation Stopping Criteria .................................................................................... 31 
9.8 Serious Adverse Events .................................................................................................................... 31 
9.8.1 Definition of a Serious Adverse Event....................................................................................... 31 
9.8.2  
Reporting Serious Adverse Events ..................................................................................... 31 
10.0 STATISTICAL METHODS ............................................................................................................... 32 
10.1 Statistical Plan ................................................................................................................................. 32 
10.1.1 Determination of Sample Size ................................................................................................. 32 
10.1.2 Safety Analysis of Potential HPA Axis Suppression ............................................................... 33 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 7 of 48 
 
 
 
10.2 Safety Analysis ............................................................................................................................... 33 
11.0 REGULATORY OBLIGATIONS ...................................................................................................... 33 
11.1 Institutional Review Board ............................................................................................................. 33 
11.2 Study Documentation ...................................................................................................................... 34 
11.2.1 Protocol .................................................................................................................................... 34 
11.2.2 Informed Consent ..................................................................................................................... 34 
11.2.3 Protocol and Informed Consent Changes ................................................................................. 34 
11.2.4 Source Documents and Case Report Forms ............................................................................. 34 
11.2.5 Drug Accountability ................................................................................................................. 35 
11.2.6 Drug Storage ............................................................................................................................ 35 
11.2.7 Pregnancies .............................................................................................................................. 35 
11.2.8 Reporting Safety Information to the IRB ................................................................................. 36 
11.2.9 Record Retention...................................................................................................................... 36 
11.2.10 Study Monitoring and Auditing ............................................................................................. 36 
11.2.11 End of the Trial ...................................................................................................................... 36 
11.2.12 Clinical Study Report ............................................................................................................. 36 
12.0 REFERENCES ................................................................................................................................... 37 
13.0 APPENDICES .................................................................................................................................... 38 
13.1 APPENDIX A ................................................................................................................................. 38 
13.2 APPENDIX B ................................................................................................................................. 39 
13.3 APPENDIX C ................................................................................................................................. 40 
13.4 APPENDIX D ................................................................................................................................. 41 
13.5 APPENDIX E ................................................................................................................................. 43 
13.6 APPENDIX F.................................................................................................................................. 44 
13.7 APPENDIX G ................................................................................................................................. 45 
13.8 APPENDIX H: ................................................................................................................................ 48 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 8 of 48 
 
 
 
4.0 SYNOPSIS 
 
Protocol Number 
DSXS 1538b 
Title 
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression 
Following Maximal Use Treatment with Desoximetasone 0.25% Shampoo 
(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to Severe 
Scalp Psoriasis 
Objectives 
The objectives of this study are to: 
1. Evaluate the potential of desoximetasone 0.25% shampoo to suppress 
HPA axis function in patients with moderate to severe scalp psoriasis. 
2. Evaluate the efficacy parameters and adverse event (AE) profiles of 
desoximetasone 0.25% shampoo administered to patients with moderate 
to severe scalp psoriasis. 
Sponsor 
Taro Pharmaceuticals U.S.A., Inc. 
Name of Test 
Product 
Desoximetasone 0.25% shampoo 
Route of 
Administration 
Topical 
Study Design 
An open-label, safety study to assess the potential for adrenal suppression 
following maximal use treatment with desoximetasone 0.25% shampoo 
applied once-daily for 28 days in patients with moderate to severe scalp 
psoriasis. Each patient is expected to receive 28 doses of study product. 
Study Population 
Approximately 5-10 male or female patients 12-17 years of age with a 
confirmed diagnosis of moderate to severe plaque psoriasis of the scalp with 
≥ 20% scalp affected. 
Study Conduct 
All patients will attend the clinic for 3 scheduled visits and a telephone 
follow-up phone call (Visit 4): 
Visit 1: Screening/Enrollment (Day 1) 
Visit 2: Interim Visit (Day 14 ± 2) 
Visit 3: End of Study (Day 29 ± 2) or Early Termination 
Visit 4: Follow Up (Day 42± 4) Telephone Phone Call  
If 5 or more patients experience biochemical abnormal values suggestive of 
possible HPA axis suppression, enrollment will be stopped. Such abnormality 
is defined by a 30 minute post CortrosynTM injection level cortisol level of 
≤ 18 mcg/100ml during the Cortisol Response Test. 
Inclusion Criteria 
1. Male or non-pregnant, non-lactating females 12-17 years of age. 
2. If female and of childbearing potential, prepared to abstain from sexual 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 9 of 48 
 
 
 
intercourse or use a reliable method of contraception during the study 
(e.g., 
condom, 
IUD, 
oral, 
transdermal 
or 
injected 
hormonal 
contraceptives). Female patients using hormonal contraceptives should 
have been on the same product/dosing regimen for at least 28 days before 
baseline and should not change this regimen during the study. 
3. Signed IRB approved informed consent given by parent(s) or legally 
acceptable guardian(s) following their receipt of verbal and written 
information about the study.  For patients age 12-17 years of age the child 
will be required to sign a patient “assent” form that will be written in such 
a way as to be understandable to a child. 
4. Patients with a confirmed clinical diagnosis of stable plaque psoriasis of 
the scalp with ≥ 20% scalp affected. 
5. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 
(Severe). 
Exclusion Criteria 
1.  Females who are pregnant, nursing, planning to become pregnant during 
the duration of the study, or if of child-bearing potential and sexually 
active and not prepared to use appropriate contraceptive methods to avoid 
pregnancy. 
2. Patients < 12 years of age or > 17 years of age. 
3. Patients whose scalp psoriasis necessitates systemic or other concomitant 
topical therapies during the study. Concomitant treatment of body 
psoriasis with OTC topical products, including emollients, is allowed. 
4. IGA score < 3. 
5. Scalp psoriasis with < 20% scalp affected. 
6. History of psoriasis that has been unresponsive to topical corticosteroid 
therapy. 
7. Patient has a scalp skin condition that would interfere with the diagnosis 
or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, 
eczema, cutaneous T-cell lymphoma, or other forms of psoriasis 
including guttate, inverse, pustular or erythrodermic psoriasis). 
8. History of an adverse reaction to CortrosynTM or similar test reagents 
9. Presence of pigmentation, extensive scarring, pigmented lesions, or 
sunburn in the treatment areas that could interfere with the rating of 
efficacy parameters, including planned extensive exposure to sunlight 
during the study. 
10. History of allergy or sensitivity to corticosteroids or history of any drug 
hypersensitivity or intolerance which, in the opinion of the Investigator, 
would compromise the safety of the patient or the results of the study. 
11. Patient has a significant history or current evidence of chronic infectious 
disease, 
system 
disorder, 
organ 
disorder 
or 
insufficiency, 
immunosuppression (from medical treatment or disease), organ transplant 
or other medical condition that, in the Investigator’s opinion, would place 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 10 of 48 
 
 
 
the study patient at undue risk by participation in the study. 
12. Patient is currently receiving or has received any radiation therapy or 
anti-neoplastic agents within 3 months before baseline. 
13. Known history of hypothalamic-pituitary-adrenal axis impairment or any 
other disturbance of the adrenal function (e.g. Cushing or Addison 
disease). 
14. Known or suspected severe renal insufficiency or severe hepatic 
disorders or severe heart disease. 
15. Patients who have a history of or current diagnosis of glaucoma or 
posterior subcapsular cataracts or any other ocular condition that, in the 
opinion of the Investigator, would place study patient at undue risk. 
16. Patients who have had surgery on the eyes or eyelids within 1 month 
before baseline or plan to have eye or eyelid surgery during the study. 
17. Patients with active infection (including but not limited to bacterial, 
fungal and viral infection) and/or open wounds on the entire head and 
neck area. 
18. Use within 4 weeks before baseline of 1) oral or intravenous 
corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus 
ultraviolet A therapy, 4) topical tacrolimus, 5) topical pimecrolimus, 6) 
systemic retinoids or 7) any other systemic psoriasis treatment 
19. Use of tanning booths or nonprescription UV light source within 2 weeks 
before baseline. 
20. Use within 8 weeks before baseline of 1) immunomodulators or 
immunosuppressive therapies or 2) interferon. 
21. Use within 14 days before baseline of calcipotriene or other Vitamin D 
preparations. 
22. Changed brands/types or frequency of use of routine hair care products 
(shampoo, conditioner, sprays etc.) within 14 days before baseline, or 
intend to change during the study. 
23. Use of systemic antibiotics or prescription-strength systemic anti-
inflammatory agents within 1 month before baseline. 
24. Use of the following within 2 weeks before baseline: 
a. Topical anti-psoriatic agents. 
b. Topical corticosteroids. 
c. Topical retinoids. 
d. Topical anti-inflammatory agents. 
e. Medicated shampoos for scalp psoriasis (including coal tar 
shampoo). 
f. New regimens of beta blockers. 
g. Lithium preparations. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 11 of 48 
 
 
 
h. Anti-malarial agents. 
25. Patient has been treated within 12 weeks before baseline with any 
biological therapies for psoriasis.  
26. Inability to understand the protocol requirements, instructions, and study-
related restrictions, the nature, scope, and possible consequences of the 
clinical study. 
27. Unlikely to comply with the protocol requirements, instructions, and 
study-related restrictions, such as uncooperative attitude, inability to 
return for follow-up visits, and improbability of completing the clinical 
study. 
28. Receipt of any drug as part of a research study within 30 days before 
baseline. 
29. The patient is a member of the investigational study staff or a member of 
the family of the investigational study staff. 
30. Previous participation in this study. 
Criteria for 
Evaluation 
Primary Outcome Measures: 
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin 
demonstrating the absence or presence of adrenal suppression at the end of 
treatment defined by the following criteria: 30 minute post CortrosynTM 
injection level cortisol level of ≤ 18 mcg/100ml during the Cortisol Response 
Test 
Secondary Outcome Measures: 
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin 
demonstrating the presence of adrenal suppression at the end of treatment 
with % Scalp Affected as a covariate 
HPA Axis 
Evaluation 
If at the end of the study the patient has a cortisol response test that is 
suggestive of HPA axis suppression, they will have a follow up test at least 
every 4 weeks in accordance to the follow up calendar in Appendix D or until 
such time as the Investigator considers the adrenal function has turned to 
normal. 
Patients with normal adrenal function at baseline will be included in the HPA 
Axis evaluation. 
Primary Analysis: 
Proportion of patients in the study with HPA axis suppression following 
treatment with the study medication. 
Secondary Analysis: 
A logistic regression of the proportion of patients in the study with HPA axis 
suppression will be performed with % scalp affected as a covariate. 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 12 of 48 
 
 
 
Safety Parameters 
Adverse events will be classified using standard MedDRA terminology 
Version 19 or higher and summarized over all patients. Adverse events 
reported during the study will be tabulated in summary table by type, date of 
onset, date of resolution, incidence, severity, action taken, outcome and 
Investigator’s opinion of relationship to the study product. Signs and 
symptoms of scalp psoriasis will not be considered adverse events, unless in 
the Investigator’s opinion, they have increased in frequency and/or severity to 
such an extent that the Investigator/patient considers that it is in the patient’s 
best interest to be dropped from continued participation in the study and 
given alternative therapy for their condition. 
Concomitant medication use during the study will be tabulated by patient. 
Ocular safety evaluations will be assess at the discretion of the Investigator 
based on the findings of the HEENT exam performed at each visit along with 
the ocular discomfort reported by the patient.  Ocular discomfort will be 
assessed by the patients and reported to staff during clinic visits. 
Sample Size 
Determination 
The sample size of 5-10 evaluable patients was deemed appropriate to meet 
the objectives of the study. 
 
 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 13 of 48 
 
 
 
5.0 STUDY SCHEMATIC 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Day 
1 
14 ± 2 
29 ± 2 
42 ± 4 
Procedures 
Screening/ 
Enrollment 
Before 12 pm 
Interim 
Visit 
End of 
Study/Early 
Termination 
Before 12 pm 
Telephone 
Follow-Up 
Visit 
Informed 
Consent/Assent 
X 
 
 
 
Medical History and 
Demographics 
X 
 
 
 
Vital Signs 
X 
X 
X 
 
Pregnancy Test* 
X 
X 
X 
 
Physical Exam 
X 
 
X 
 
HEENT Exam 
X 
X 
X 
 
% Scalp Affected 
X 
X 
X 
 
Investigator Global 
Assessment 
X 
X 
X 
 
Concomitant Medication 
X 
X 
X 
X 
Laboratory Evaluations 
X 
 
X 
 
Cortisol Response Test 
X 
 
X 
 
Confirm Inc/Exc 
Criteria 
X 
 
 
 
Dispense Wristband 
X 
 
 
 
Weigh and Dispense 
Study Product 
X 
X 
 
 
Collect and Weigh 
Study Product 
 
X 
X 
 
Dispense/Review Patient 
Diary 
X 
X 
X 
 
Ocular Assessment 
 
X 
X 
 
Adverse Events 
 
X 
X 
X 
Evaluation of Patient 
Compliance to the 
Protocol 
 
X 
X 
 
* Pregnancy test will be carried out for females of childbearing potential. 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 14 of 48 
 
 
 
6.0 LIST OF ABBREVIATIONS AND TERMS 
 
Abbreviation Term 
ADL 
Activities for Daily Living 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
BP 
Blood Pressure 
C 
Celsius 
CRF  
Case Report Form 
CRO  
Clinical Research Organization 
eCTD 
electronic Common Technical Document 
FDA  
Food and Drug Administration 
HR 
Heart Rate 
HRT  
Hormone Replacement Therapy 
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 
IUD  
Intrauterine Device 
LOCF 
Last Observation Carried Forward 
ml 
Milliliter 
mITT 
Modified Intent-to-Treat 
NDA  
New Drug Application 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
OHRP 
Office of Human Rights Protection 
OTC  
Over-the-Counter 
PUVA 
Psoralen and UltraViolet A 
RR 
Respiratory Rate 
SAE  
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
USA  
United States of America 
 
 
 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 15 of 48 
 
 
 
7.0 INTRODUCTION 
Taro Pharmaceuticals U.S.A., Inc. (Taro) plans to submit an Investigational New Drug Application (IND) 
for a new formulation of desoximetasone: desoximetasone 0.25% shampoo. This product contains a potent 
corticosteroid to be indicated for the treatment of patients with moderate to severe psoriasis. 
7.1 Disease Being Treated 
Psoriasis is an immune (T-cell)-mediated inflammatory skin disease that affects approximately 2% of 
the western population.1 The most common type of psoriasis in both adults and children is plaque 
psoriasis, which is characterized by the presence of raised, thickened red lesions that are covered by 
silvery white scales, most commonly seen on the knees and/or elbows. Although there are reports 
implicating a genetic association with the disease, there are also studies that have established a set of 
psoriasis triggers including stress, medications (such as lithium, antimalarials, indomethacin, 
quinidine, beta blockers), injury or infection. The condition is considered chronic although the 
frequency and severity of outbreak in an individual can fluctuate without apparent cause.1-3 
At least 50% of all psoriasis cases have scalp psoriasis. Although head represents only 10% of the 
whole body surface, the visibility and symptoms of scalp psoriasis can be seriously debilitating for 
many patients, inducing social and emotional distress and negatively impacting quality of life.4 Scalp 
psoriasis is more difficult to treat compared to psoriasis of the body, because the skin of the scalp is 
less accessible to topical treatments primarily because of the presence of hair. Moreover, vehicles 
used in psoriasis medications are often not cosmetically acceptable for scalp treatment, thereby 
negatively impacting treatment adherence. There is a need for effective, safe and cosmetically 
acceptable products for the treatment of scalp psoriasis to improve both compliance and response to 
treatment.5 
7.2 Availability and Efficacy of Already Approved Therapies 
Treatment of plaque psoriasis depends on the severity of the condition, previous treatment regimens 
and personal preference of the patient. Scalp psoriasis treatments historically include topical creams, 
sprays, lotions, foams, and the more recently introduced shampoos. Examples of marketed products 
include corticosteroids (Topicort®, Clobex™), Vitamin A and D derivatives (Tazorac®, Dovonex®), 
NSAIDs (salicylic acid), etc. For more severe cases, systemic therapy (methotrexate, oral retinoids, 
UV light, biologics, etc) may be warranted; however, the side effect profile of these products limits 
their use.1,2,5-7 
Desoximetasone is a high potency synthetic corticosteroid marketed in a number of formulations: gel 
(0.05%), cream (0.05% and 0.25%), and ointment (0.05% and 0.25%). All these formulations are 
encompassed under the Topicort® brand, acquired by Taro Pharmaceuticals U.S.A., Inc. (Taro) in 
2004. Most recently, Taro received approval on April 11, 2013 for a new dosage form (spray) under 
NDA #204141, Topicort® (desoximetasone) Spray, 0.25%, a super high potency formulation that is 
indicated for the treatment of plaque psoriasis in patients 18 years of age or older.8 Topical 
application of high potency steroids at the recommended dosing levels are usually well tolerated in all 
populations, with less than 2% of patients reporting adverse reactions (7% in the pediatric 
population). The most commonly reported adverse events are burning, stinging, pruritus, and skin 
thinning/atrophy.1,2,5-7 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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Shampoos are considered a preferred treatment option for scalp psoriasis because of ease of 
application and cosmetic acceptability. There are many OTC coal tar shampoos in the market for 
treating mild scalp psoriasis. For the moderate-severe cases, a prescription shampoo containing potent 
corticosteroids is available in the market (Clobex™ shampoo, clobetasol propionate, 0.05%). 
A new formulation of desoximetasone (desoximetasone 0.25% shampoo) has been developed by Taro 
Pharmaceuticals U.S.A., Inc. (Taro), and is the Test product used in this study 
7.3 Scientific and Statistical Considerations 
In some instances high potency steroids applied topically have been known to cause suppression of 
the hypothalamic-pituitary-adrenal (HPA) axis. In order to assess HPA axis function plasma levels of 
cortisol are measured before (basal) and after a bolus administration of synthetic α 1-24-
adrenocorticotropic hormone (ACTH).  In this study CortrosynTM (cosyntropin, a synthetic subunit of 
ACTH) (Amphstar Pharmaceuticals, Inc.) will be used according to manufacturer instructions to 
assess HPA axis function (See Appendices D, E).9 Recovery from steroid-induced adrenal 
insufficiency is usually rapid after the treatment is withdrawn.10 See Appendix D for further 
explanation of the evaluation of the role of topical corticosteroids in HPA axis suppression. 
Taro Pharmaceuticals U.S.A. has recently completed an open label safety and efficacy study to assess 
adrenal suppression in adults with moderate to severe plaque psoriasis after 4 weeks of treatment 
under maximal use conditions with the test product, desoximetasone 0.25% spray. Of 21 evaluable 
subjects, adrenal suppression was identified in 1 of 12 subjects having involvement of 10-15% of 
body surface area (BSA) and 2 of 9 subjects having involvement of > 15% of BSA after treatment 
with Topicort® Topical Spray twice a day for 28 days. Adrenal function returned to normal at the first 
follow-up visit, which was 28 days after the end of treatment, for all 3 of these patients11 
This study design is based on similar studies performed, submitted and accepted by the FDA for 
recently approved high potency spray and foam topical corticosteroid formulations, topical 
corticosteroid/topical vitamin D3 analogue combination agents, and recommendations from the FDA 
in IND 101789 Guidance Meeting that took place on 01/14/2015 and an FDA Advice Letter dated 
04/27/2015 (Reference ID: 3740601) for desoximetasone 0.15% topical spray, and recommendations 
provided by the FDA in the Meeting Request – Written Reponses Letter dated 09/18/2013 for PIND 
118881 (Reference ID 3374240) for desoximetasone 0.25% shampoo.9,12-15 
7.4 Risks and Benefits 
Known adverse reactions to topical corticosteroids include burning, itching, irritation, dryness, 
folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic 
contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and milliaria. 
Dosing for extended periods of time may result in suppression of adrenal function. 
CortrosynTM for injection is intended diagnostic and not therapeutic use and adverse reactions other 
than a rare hypersensitivity reaction are not anticipated. Known reactions are slight whealing with 
erythema at the site of injection. 
The subject may benefit from clearing of the lesions and improvement of the condition of the disease. 
If the drug is approved, then many patients may benefit from its use. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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The potential risks and benefits of participation in the study will be explained to the patient 
verbally and written in the informed consent form. 
All patients enrolled in this study will receive the benefit of free specialized medical care, beyond 
standard medical treatment that would be expected through most health insurance plans. In addition, 
the patient will receive a stipend as compensation for time and inconvenience related to study 
participation including costs associated with travel to and from the medical facility.  
Ethical consideration related to this protocol and the use of human patients will be reviewed by an 
IRB. 
8.0 STUDY OBJECTIVES 
The objectives of this study are to: 
1. Evaluate the potential of desoximetasone 0.25% shampoo to suppress HPA axis function in 
patients with moderate to severe scalp psoriasis. 
2. Evaluate the efficacy parameters and adverse event (AE) profiles of desoximetasone 0.25% 
shampoo administered to patients with moderate to severe scalp psoriasis. 
9.0 INVESTIGATIONAL PLAN 
9.1 Study Design and Plan Description 
This open-label, safety study is designed to evaluate the potential for adrenal suppression after 
maximal use treatment with desoximetasone 0.25% shampoo (Taro Pharmaceuticals, U.S.A.), for the 
treatment of moderate to severe scalp psoriasis.  
Up to 5-10 eligible patients with stable plaque psoriasis of the scalp that satisfy all eligibility criteria 
will be enrolled into the study at Visit 1. Patients must be overall in good health. They should have a 
current diagnosis of moderate to severe scalp psoriasis with IGA score of at least 3 or 4. 
Up to 5-10 patients with a confirmed diagnosis of moderate to severe scalp psoriasis  
Patients enrolled in the study will apply product once daily for 28 days, according to provided 
instructions. Each patient is expected to receive 28 doses of study product. 
Patients will attend a total of 3 Clinic Visits and a telephone follow-up phone call (Visit 4) as follows: 
 
Visit 1 (Day 1): Enrollment 
 
Visit 2 (Day 14±2): Interim Visit  
 
Visit 3 (Day 29 ± 2): End of Study or Early Termination  
 
Visit 4 (Day 42± 4): Follow-up Telephone Phone Call  
The primary endpoint is the proportion of patients in the study with HPA axis suppression following 
treatment with the study medication. 
The safety profile of each treatment group will be evaluated by comparing adverse events. 
Ethical consideration related to this protocol and the use of human patients will be reviewed by an 
IRB. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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9.2 Selection of Study Design 
This study design is based on similar studies performed, submitted and accepted by the FDA for 
recently approved high potency spray and foam topical corticosteroid formulations, topical 
corticosteroid/topical vitamin D3 analogue combination agents, and recommendations from the FDA 
in IND 101789 Guidance Meeting that took place on 01/14/2015 and an FDA Advice Letter dated 
04/27/2015 (Reference ID: 3740601) for desoximetasone 0.15% topical spray, and recommendations 
provided by the FDA in the Meeting Request – Written Reponses Letter dated 09/18/2013 for PIND 
118881 (Reference ID 3374240) for desoximetasone 0.25% shampoo.9,12-15 
9.3 Selection of Study Population 
9.3.1 Inclusion Criteria 
1. Male or non-pregnant, non-lactating females 12-17 years of age. 
2. If female and of childbearing potential, prepared to abstain from sexual intercourse or use a 
reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal or 
injected hormonal contraceptives). Female patients using hormonal contraceptives should 
have been on the same product/dosing regimen for at least 28 days before baseline and should 
not change this regimen during the study. 
3. Signed IRB approved informed consent given by parent(s) or legally acceptable guardian(s) 
following their receipt of verbal and written information about the study.  For patients age 12-
17 years of age the child will be required to sign a patient “assent” form that will be written in 
such a way as to be understandable to a child. 
4. Patients with a confirmed clinical diagnosis of stable plaque psoriasis of the scalp with ≥ 20% 
scalp affected. 
5. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4(Severe) 
9.3.2 Exclusion Criteria 
1. Females who are pregnant, nursing, planning to become pregnant during the duration of the 
study, or if of child-bearing potential and sexually active and not prepared to use appropriate 
contraceptive methods to avoid pregnancy. 
2. Patients < 12 years of age or > 17 years of age. 
3. Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies 
during the study. Concomitant treatment of body psoriasis with OTC topical products, 
including emollients, is allowed. 
4. IGA score < 3. 
5. Scalp psoriasis with < 20% scalp affected. 
6. History of psoriasis that has been unresponsive to topical corticosteroid therapy. 
7. Patient has a scalp skin condition that would interfere with the diagnosis or assessment of 
plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, 
or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis). 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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8. History of an adverse reaction to CortrosynTM or similar test reagents 
9. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment 
areas that could interfere with the rating of efficacy parameters, including planned extensive 
exposure to sunlight during the study. 
10. History of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or 
intolerance which, in the opinion of the Investigator, would compromise the safety of the 
patient or the results of the study. 
11. Patient has a significant history or current evidence of chronic infectious disease, system 
disorder, organ disorder or insufficiency, immunosuppression (from medical treatment or 
disease), organ transplant or other medical condition that, in the Investigator’s opinion, would 
place the study patient at undue risk by participation in the study. 
12. Patient is currently receiving or has received any radiation therapy or anti-neoplastic agents 
within 3 months before baseline. 
13. Known history of hypothalamic-pituitary-adrenal axis impairment or any other disturbance of 
the adrenal function (e.g. Cushing or Addison disease). 
14. Known or suspected severe renal insufficiency or severe hepatic disorders or severe heart 
disease. 
15. Patients who have a history of or current diagnosis of glaucoma or posterior subcapsular 
cataracts or any other ocular condition that, in the opinion of the Investigator, would place 
study patient at undue risk. 
16. Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan 
to have eye or eyelid surgery during the study. 
17. Patients with active infection (including but not limited to bacterial, fungal and viral 
infection) and/or open wounds on the entire head and neck area. 
18. Use within 4 weeks before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB 
therapy, 3) PUVA (psoralen plus ultraviolet A therapy, 4) topical tacrolimus, 5) topical 
pimecrolimus, 6) systemic retinoids or 7) any other systemic psoriasis treatment 
19. Use of tanning booths or nonprescription UV light source within 2 weeks before baseline. 
20. Use within 8 weeks before baseline of 1) immunomodulators or immunosuppressive therapies 
or 2) interferon. 
21. Use within 14 days before baseline of calcipotriene or other Vitamin D preparations. 
22. Changed brands/types or frequency of use of routine hair care products (shampoo, 
conditioner, sprays etc.) within 14 days before baseline, or intend to change during the study. 
23. Use of systemic antibiotics or prescription-strength systemic anti-inflammatory agents within 
1 month before baseline. 
24. Use of the following within 2 weeks before baseline: 
a. Topical anti-psoriatic agents. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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b. Topical corticosteroids. 
c. Topical retinoids. 
d. Topical anti-inflammatory agents. 
e. Medicated shampoos for scalp psoriasis (including coal tar shampoo). 
f. New regimens of beta blockers. 
g. Lithium preparations. 
h. Anti-malarial agents. 
25. Patient has been treated within 12 weeks before baseline with any biological therapies for 
psoriasis.  
26. Inability to understand the protocol requirements, instructions, and study-related restrictions, 
the nature, scope, and possible consequences of the clinical study. 
27. Unlikely to comply with the protocol requirements, instructions, and study-related 
restrictions, such as uncooperative attitude, inability to return for follow-up visits, and 
improbability of completing the clinical study. 
28. Receipt of any drug as part of a research study within 30 days before baseline. 
29. The patient is a member of the investigational study staff or a member of the family of the 
investigational study staff. 
30. Previous participation in this study. 
9.3.3 Restrictions during the Study 
The following concomitant medications will not be allowed while enrolled in the study: 
Restricted medication 
Examples (not comprehensive) 
Wash out 
Topical corticosteroids (on scalp or 
body), retinoids or anti-
inflammatory agents (on scalp) 
Topicort® (desoximetasone 0.25%) 
spray, Cortaid® (hydrocortisone 1%), 
Clobex® ( clobetasol 0.05%), Diprolene® 
( betamethasone 0.05%), retinol, 
diclofenac, etc. 
2 weeks  
Topical anti-psoriatic medication 
(on scalp) 
Psorcon® ointment/cream, Dovonex® 
(calcipotriene), Tazorec ® (tazarotene), 
Vectical® (calcitriol), salicylic acid, 
anthralin, coal tar, etc., including 
medicated shampoos 
2 weeks  
Beta blockers, lithium preparations, 
anti-malarial agents or tanning 
booths 
metoprolol, labetalol, Eskalith, Lithobid, 
quinine, etc. 
2 weeks  


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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Biologic treatment for psoriasis 
Remicade® (infliximab), Enbrel® 
(etanercept), Humira® (adalimumab), 
etc. 
12 weeks 
Chemotherapy 
Radiation therapy 
 
3 months 
Systemic corticosteroids 
Systemic antipsoriatic treatment  
Systemic antibiotics 
PUVA therapy 
UVB therapy 
Prescription strength systemic anti-
inflammatory agents 
Prednisone 
(Short and occasional use of intranasal, 
inhaled or ophthalmic corticosteroids for 
acute and transitory conditions [e.g. 
allergic rhinitis] up to 1 mg per day is 
acceptable) 
methotrexate, cyclosporine, hydroxyurea 
 
*the use of acetylsalicylic acid for 
prophylactic use up to 325 mg/day is 
allowed, provided that the patient is on a 
stable dose for at least 3 months and the 
regimen will remain constant throughout 
the study 
4 weeks  
Systemic retinoids  
Soriatane® (acitretin), Isotretinoin etc 
4 weeks 
Systemic immunosuppressive drugs  tacrolimus, pimecrolimus  
8 weeks 
Patients and will be advised to avoid environmental conditions that may exacerbate their disease 
state. Patients will be advised to avoid exposure to sunlight of a duration that would require 
application of sunscreen. 
In addition, patients must have consistently used a single brand/type of hair care product (e.g., 
shampoo, conditioner, spray, etc.) for a minimum of 14 days prior to baseline. Patients will be 
asked to continue using the same brand/type and frequency of use throughout the study. 
Patients will be questioned about all concomitant prescription and OTC medication use at each 
study visit. All concomitant medications will be recorded in the patient’s study chart. Any patient 
who violates any of the listed restrictions should be dropped from continued participation in the 
study by the Investigator. 
9.3.4 Removal of Patients from the Study 
Patients will be advised that they are free to withdraw from the study at any time for any reason 
or, if necessary, the Investigator may withdraw a patient from the study to protect the health of 
that patient. A patient may also be withdrawn for not complying with study procedures. The 
clinical report will include all reasons for early withdrawals. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 22 of 48 
 
 
 
All patients who administer at least one dose of randomized study medication will be included in 
the safety analysis. If a patient terminates from the study early, all efforts will be made to 
complete their next visit study procedures. In case of early termination the Investigator shall fully 
document the reason for early termination. Reasons for early termination may include the 
following: 
 
Patient withdrew consent 
 
Significant adverse event that led the Investigator or patient to withdraw for safety 
reasons 
 
Worsening signs/symptoms of scalp psoriasis 
 
Development of an intercurrent condition or complication that could affect the safety of 
the patient or the validity of the evaluation of the patient’s clinical state to an extent 
considered significant by the Investigator 
 
Signs and symptoms of possible HPA axis suppression 
 
Protocol deviations/violations that in the Investigator’s opinion warrant discontinuation 
Non-compliance with dosing need not be a reason for early termination. Patients who withdraw 
or are removed from the study will not be replaced. In the event a patient withdraws or is dropped 
from the study for any reason, the Investigator will request return of the unused product and 
report the reason for the discontinued participation. 
When a patient discontinues early from the study, all study procedures required for the end of 
study should be performed at their last study visit. Patients who are discontinued from the study 
will be evaluated for safety and will be given, or referred for, appropriate treatment. 
9.4 Treatments 
9.4.1 Treatments Administration 
The patient will be instructed to apply the study product to psoriasis-affected areas of the dry 
scalp once daily for 28 days. Patients are to move the hair away from the dry scalp so that one of 
the affected areas is exposed. A small amount of the study shampoo is to be applied directly to 
the affected area by gently squeezing the bottle. The shampoo is to be gently rubbed into the 
affected area. The same procedure is to be followed for other affected areas on the scalp. Patients 
will be instructed to use only enough to cover affected areas and avoid application to face, groin, 
armpits, lips or eyes. If during application the product comes in contact with the eyes or eyelids, 
patients will be instructed to rinse the area with abundant water immediately. Patients should not 
cover the head with a shower cap while the shampoo is on the scalp. The shampoo is to be left in 
place for 15 minutes before adding water, lathering and rinsing hair and scalp completely. 
The patient will be instructed to apply the medication once daily until the patient’s next scheduled 
visit. Each patient will be provided with a dosing diary in which they will be required to record 
dosing dates and times. These diaries should be brought to each visit so that the study staff may 
check compliance. At the end of the study, the dosing diaries will be retained in the patient’s file 
as source documentation. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 23 of 48 
 
 
 
At Visit 1 qualified study patients will be provided with one 120 ml bottle of desoximetasone 
0.25% shampoo along with instructions for dosing. This bottle should be weighed before 
dispensing and the weight recorded. At Visit 2, the bottle should be collected and weighed and a 
new 120 ml bottle of shampoo should be weighed and dispensed along with dosing instructions. 
This bottle will be returned and weighed at Visit 3. 
Treatment compliance will be encouraged by instructing the patient on the proper dosing 
technique and by the use of the daily diary. Compliance will be assessed by evaluation of the 
diary. 
9.4.2 Identity of Investigational Product 
Desoximetasone 0.25% shampoo, w/w will be used in this study 
9.4.3 Method of Assigning Patients to Treatment Groups 
Patients will be assigned to the treatment in an open label fashion. 
9.4.4 Packaging 
This is an open-label study. The study product will contain a label with the following 
information: 
 
Protocol number 
 
Bottle number 
 
Space for patient number, patient’s initials and dispensed date 
 
A note that the drug is for Investigational Use Only 
9.4.5 Accountability 
The Investigator or designee will maintain an inventory of all study product supplies received. 
9.5 Study Conduct 
The cortisol response test is to be done in the morning as the body’s peak cortisol level is directly 
related to the event of awakening. Visit 1 and Visit 3 should be scheduled before noon and subjects 
should not apply the study drug within 12 hours of Visit 3. 
9.5.1 Visit 1: Screening/Enrollment (Day 1), before 12 pm 
1. Informed Consent/Assent: Patients who are willing to comply with study procedures will 
read and sign the assent form. The parent or legal guardian should sign the consent form and 
the child will be required to sign a patient “assent” form that will be written in such a way as 
to be understandable to a child. 
2. Medical History and Demographics: Review the patient’s demographic and medical history 
including concomitant medication use within the last 12 weeks. 
3. Physical Examination: A general physical exam will be conducted.  
4. HEENT Examination: A general exam of the head, eyes, ears, nose and throat will be 
conducted at the clinic. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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5. % Scalp Affected: Patient’s scalp will be examined by Investigator/designated clinician to 
determine the percent surface area affected with plaque psoriasis. Refer to Appendix B. 
6. Vital Signs: The patient’s vital signs will be recorded (pulse, blood pressure, temperature and 
respiration rate). 
7. Pregnancy Test: A pregnancy test will be required of all females of child bearing potential 
prior to enrollment. 
8. Investigator’s Global Assessment: Patient’s scalp will be examined to determine a psoriasis 
severity score based on a global assessment of plaque elevation, scaling and erythema by the 
Investigator/designated clinician (refer to Appendix A). Patients with a score of 3 or more, 
indicating moderate to severe psoriasis will be included in the study. 
9. Concomitant Medication:  Review with the patient use of concomitant medication within 
the last 12 weeks. 
10. Confirm Inclusion/Exclusion Met: Confirm the patient meets all inclusion/exclusion 
criteria. 
11. Laboratory Evaluations:  A blood sample will be collected for hematology and clinical 
chemistry testing. (See Appendix F).  
12. Cortisol Response Test: All patients will have a cortisol response test performed according 
to the procedure detailed in Appendix D. 
13. Dispense Study Product:  If patient is eligible to enroll, record the weight of one bottle of 
study product and dispense with instructions. 
14. Provide Dosing Diary:  Provide diary and instruct patient regarding how it is to be filled out 
and how study product is to be used. 
15. Provide Patient Wristband:  Each patient will receive a wristband to indicate that the 
patient is using a medication that has the potential to cause HPA axis suppression. 
16. Schedule Visit 2. 
9.5.2 Visit 2 (Day 14 ± 2): Interim Visit 
1. Pregnancy Test: A pregnancy test will be required of all females of childbearing potential. 
2. Vital Signs: The patient’s vital signs will be recorded (pulse, blood pressure, temperature and 
respiration rate). 
3. HEENT Examination: A general exam of the head, eyes, ears, nose and throat will be 
conducted at the clinic 
4. % Scalp Affected: Patient’s scalp will be examined by Investigator/designated clinician to 
determine the percent surface area affected with plaque psoriasis. Refer to Appendix B  
5. Investigator’s Global Assessment: Patient’s scalp will be examined to determine a psoriasis 
severity score based on a global assessment of plaque elevation, scaling and erythema by the 
Investigator/designated clinician (refer to Appendix A).  


CONFIDENTIAL PROTOCOL 
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with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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6. Concomitant Medication:  Review with the patient use   of new or change in ongoing 
concomitant medication since Visit 1. 
7. Adverse Events: Patients will be questioned about any health status changes/adverse events 
since last visit. All events will be recorded. 
8. Ocular Assessments: Patients will be questioned about any ocular discomfort as a part of 
safety assessments (refer to Appendix C) 
9. Evaluation of Patient Compliance to the Protocol: Collect and review patient’s dosing 
diary for compliance and provide a new diary. Non-compliance with dosing does not warrant 
dismissal from the study. Counsel non-compliant patients on dosing requirements of the 
study. 
10. Collect Study Product: The used bottle of study drug will be collected and the weight 
recorded. 
11. Dispense New Study Product: If patient continues in the study, record weight of one new 
bottle of study product and dispense.  
12. Provide Dosing Diary: If patient continues in the study, provide a new dosing diary. 
13. Schedule Visit 3 
9.5.3 Visit 3 (Day 29 ± 2): End of Study or Early Termination, Before 12 pm 
1. Vital Signs: The patient’s vital signs will be recorded (pulse, blood pressure, temperature and 
respiration rate). 
2. Pregnancy Test: A pregnancy test will be required of all females of child bearing potential. 
3. Physical Exam: A general physical exam will be conducted. 
4. HEENT Examination: A general exam of the head, eyes, ears, nose and throat will be 
conducted at the clinic 
5. % Scalp Affected: Patient’s scalp will be examined by Investigator/designated clinician to 
determine the percent surface area affected with plaque psoriasis. Refer to Appendix B  
6. Investigator’s Global Assessment: Patient’s scalp will be examined to determine a psoriasis 
severity score based on a global assessment of plaque elevation, scaling and erythema by the 
Investigator/designated clinician (refer to Appendix A).  
7. Concomitant Medication: Review with the patient use of new or change in ongoing 
concomitant medication since Visit 2. 
8. Adverse Events: Patients will be questioned about any health status changes/adverse events 
since last visit. All events will be recorded. 
9. Ocular Assessments: Patients will be questioned about any ocular discomfort as a part of 
safety assessments (refer to Appendix C) 
10. Evaluation of Patient Compliance to the Protocol: Collect and review patient’s dosing 
diary for compliance.  


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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11. Collect Study Product: The used bottle of study product will be collected and the weight 
recorded. 
12. Laboratory Evaluations: A blood sample will be collected for hematology and clinical 
chemistry testing. (See Appendix F).  
13. Cortisol Response Test: All patients will have a cortisol response test performed according 
to the procedure detailed in Appendix D. 
9.5.4 Visit 4 (Day 42 ± 4): Follow-up Phone Call 
A phone call will be conducted approximately 14 days after the subject has completed dosing to 
follow-up on any new adverse events or new or changed concomitant medications that may have 
occurred. 
9.6 Study Procedures 
9.6.1 Informed Consent/Assent 
At Visit 1, before any study related procedures, the parent/legal guardian must sign the IRB-
approved consent form. The patient must sign the assent form. Both the consent and assent forms 
will be reviewed and approved by an Institutional Review Board before study commencement. 
No patient will be entered into the study without reading, understanding, and signing an assent 
form and parent/legal guardians signing an informed consent form. If any other language is 
required, translation will be performed by a certified translator.  
9.6.2 Demographics 
At screening, each patient shall be required to provide basic demographic information: date of 
birth, gender, ethnicity and race. 
9.6.3 Medical History 
At Visit 1, patients will be questioned about medical history, including acute and chronic medical 
history and medical history relevant to their scalp psoriasis, as well as all medication use within 
the past 12 weeks. 
9.6.4 Vital Signs 
The patient’s vital signs will be recorded (heart rate, blood pressure, temperature and respiration 
rate) at Visit 1, 2, and 3. 
9.6.5 Physical Exam  
A general physical exam will be conducted at Visit 1 and Visit 3. The physical exam must include 
a dermatological examination as a minimum. 
9.6.6 HEENT Exam 
A head, eye, ear, nose, throat (HEENT) examinations will be conducted at each clinic visit (Visit 
1, 2 and 3). 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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9.6.7 Percent Scalp Affected 
Patient’s scalp will be examined by Investigator/ designated clinician to determine the percent 
surface area affected with plaque psoriasis at all visits. At each subsequent visit, the % affected 
area will be monitored and documented. Refer to Appendix B.16 
9.6.8 Investigator Global Assessment 
Patient will be examined to determine the severity of scalp psoriasis based on a global assessment 
of plaque elevation, scaling and erythema by the Investigator/designated clinician (refer to 
Appendix A). 
9.6.9 Ocular Discomfort Assessment 
Ocular discomfort will be assessed by subjects and reported to clinic staff during scheduled visits 
(refer to Appendix D). If the shampoo comes into contact with the patient’s eyes, the patient will 
be asked to report the contact at each visit. 
Ocular safety evaluations will be assessed at the discretion of the Investigator based on the 
findings of the HEENT exam performed at each visit along with the ocular discomfort reported 
by the patient. Medical records associated with the ocular safety evaluation should be obtained 
for the study chart. 
9.6.10 Concomitant Medication Use 
At Visits 1-3 and during the follow-up phone call (Visit 4) patients will be questioned about 
current and concomitant medication use over the previous 12 weeks. At all Interim Visits patients 
will be questioned about ongoing or new concomitant medication use. 
9.6.11 Pregnancy Test 
Urine pregnancy tests on females of childbearing potential will be performed at Visit 1, 2, and 3. 
The test must be negative for the patient to be eligible for inclusion in the study. If the patient is 
of non-childbearing potential, the source document must list the reason why she is of non-
childbearing potential (e.g., premenarchal). 
Any patient who becomes pregnant during the study must be discontinued and End of Study 
procedures completed. The outcome of the pregnancy will be followed by the Investigator to birth 
or early termination as appropriate. The pregnancy will be reported as an AE. 
9.6.12 Dispensing Study Product 
At Visit 1 patients that satisfy all of the inclusion/exclusion criteria will be dispensed one bottle 
of the study product and dosing instructions. At Visit 2 (Day 14) a new bottle of study product 
will be dispensed. 
The weight of the study product should be recorded before dispensing. 
9.6.13 Collecting Study Product 
Study product bottles will be collected and weighed at Visits 2 and 3. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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9.6.14 Dosing Instructions and Diary 
Patients will be provided with a diary to record the time and date of dosing, other concomitant 
medications and adverse events. Patients applying fewer than 75% or more than 125% of the 
required doses will be considered non-compliant with dosing. Compliance with dosing will be 
verified by the use of the patient diaries. 
9.6.15 Dosing Compliance 
Dosing compliance will be checked by site staff at Visits 2 and 3. Patients taking fewer than 75% 
or more than 125% of the scheduled doses will be considered non-compliant with dosing. 
Compliance with dosing will be verified by the use of the patient diaries. 
 
 
Compliance Criteria 
Duration 
Scheduled 
Doses 
Not more than 
125% (doses) 
Not less than 
75% (doses) 
28 Days 
28 
35 
21 
9.6.16 Patient Wristband 
Each patient who enters the study will be provided with a wristband at Visit 1 to identify that the 
patient is taking a medication that could potentially cause HPA axis suppression. The patient 
should be instructed to wear the wristband for the duration of the study. 
9.6.17 Laboratory Evaluation 
At Visit 1 and Visit 3 a blood sample will be collected for hematology and clinical chemistry 
testing (See Appendix F).  
9.6.18 Cortisol Response Test 
At Visit 1 and Visit 3 all patients will have a cortisol response test performed according to the 
procedure detailed in Appendix D.  The resulting blood sample should be sent to ACM Global 
Laboratory for immediate testing.  
The test at the End of Study visit should not be performed if the patient dosed within 12 hours. 
A patient will be considered to have normal basal cortisol level and adrenal function if they meet 
all three criteria listed below under Normal. Failure to meet any of these criteria is indicative of 
abnormal adrenal function or potential HPA axis suppression, even in absence of related 
symptoms (e.g. nausea, headache, myalgia, fatigue or loose stool); for abnormal results, the 
patient will be monitored in accordance to the follow-up schedule below. 
 
Cortisol Results 
Normal 
Abnormal 
Basal 
(pre CortrosynTM 
injection) 
≥ 5 mcg/100ml 
< 5 mcg/100ml 
30 minutes post 
≥ basal value + 7 
< basal value + 7 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 29 of 48 
 
 
 
CortrosynTM injection 
> 18 mcg/100ml 
≤ 18 mcg/100ml 
HPA Axis suppression will be defined as a 30 minute post CortrosynTM injection level cortisol 
level of ≤ 18 mcg/100ml. If the Visit 1 Cortisol Response Test shows signs of HPA axis 
suppression as defined above the patient will be contacted and instructed to discontinue the use of 
study product, not to initiate any new steroid therapy, topical or otherwise and an End of Study 
Visit will be scheduled to conduct a Cortisol Response Test at least 28 days after the initial 
Cortisol Response Test at Visit 1 to assess for HPA axis suppression.  At Visit 3 the study 
treatment period will be over, any patients with results of HPA axis suppression will be advised 
not to initiate any new steroid therapy, topical or otherwise, and to return to the site in 28 days at 
which time they will be assessed for HPA axis suppression.  
Any patient presenting with symptoms of HPA axis suppression, such as nausea, headache, 
myalgia, fatigue or loose stool, will be referred to an endocrinologist. As an additional safety 
precaution, wristbands identifying the patient as someone suffering from adrenal suppression 
secondary to steroid withdrawal will be provided to alert medical personnel should any 
emergencies arise before adrenal function returns to normal.  
If the results of the cortisol response test still show signs of HPA axis suppression 28 days after 
discontinuing therapy the patient will be asked to return in 28 days (56 days after discontinuing 
steroid therapy) for another follow-up test. If the patient is still showing signs of HPA axis 
suppression 56 days after discontinuing steroid therapy and presents with related symptoms, the 
patient will be referred to an endocrinologist.  
If HPA axis suppression persists for 56 days after discontinuing steroid therapy, but the patient 
has no symptoms they will be asked to return in 28 days (84 days after discontinuing steroid 
therapy) for another follow-up test. If HPA axis suppression persists for 84 days after 
discontinuing steroid therapy the patient will be referred to an endocrinologist regardless of 
symptoms.  
Patients should not be subjected to CortrosynTM testing, or any other challenge to their adrenal 
response, any sooner than 4 weeks from their last CortrosynTM test.  
Follow-Up Schedule for Patients showing signs of HPA Axis Suppression 
Days 
after d/c 
HPA Results 
Symptoms 
Patient Course 
28 
Normal 
N/A 
Study over 
28 
Abnormal 
Yes 
Refer to endocrinologist 
28 
Abnormal 
No 
Repeat test in 28 days 
56 
Normal 
N/A 
Study over 
56 
Abnormal 
Yes 
Refer to endocrinologist 
56 
Abnormal 
No 
Repeat test in 28 days 
84 
Normal 
N/A 
Study over 
84 
Abnormal 
Yes or No 
Refer to an endocrinologist 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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9.7 Adverse Events 
The patients will be monitored throughout the study for any Adverse Events. AEs will be collected 
through both solicited and unsolicited means and subsequently coded in tabular form using the 
MedDRA (Version 19 or higher) Adverse Event Dictionary. The patients will be encouraged to report 
signs, symptoms, and any changes in health to the clinic staff. Severity of each AE will be determined 
by the staff based on observation and questioning of the patients. The Investigator will judge the 
relationship of the event to the study treatments. Adverse events should be followed up until they have 
resolved or stabilized. 
9.7.1 Adverse Event Definitions 
Adverse Event: Any untoward medical occurrence in a patient or clinical investigation patient 
administered a pharmaceutical product and which does not necessarily have a causal relationship 
with treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or 
disease, temporally associated with the use of a medicinal (investigational) product, whether or 
not related to this product. This includes events not seen at baseline, or worsened even if present 
at baseline.  
Unexpected Adverse Event: An adverse event where the nature or severity of is not consistent 
with the applicable product information (e.g., Investigator’s Brochure for an unapproved 
investigational product or package insert/summary of product characteristics for an approved 
product).  
Adverse Drug Reaction: All noxious and unintended responses to a medical product related to 
any dose should be considered adverse drug reactions. The response to a ‘medical product’ means 
that a causal relationship between a medicinal product and an adverse event is at least a 
reasonable possibility, i.e., the relationship cannot be ruled out. 
9.7.2 Severity of Adverse Event 
The severity of the adverse event will be graded by the Investigator using the following criteria as 
guidelines:  
 
MILD: Awareness of symptom but does not interfere with routine activities.  
 
MODERATE: Discomfort sufficient to interfere with routine activities.  
 
SEVERE: Impossible to perform routine activities. 
9.7.3 Relationship of Adverse Event 
Relationship to the Study Product 
 
NOT RELATED: Any AE that is clearly not related to use of the study drug. 
 
POSSIBLE: The association of the AE with the study drug is unknown; however, a 
relationship between the drug and event cannot be ruled out.  
 
PROBABLE: There is reasonable temporal relationship between the use of the study drug 
and the AE. Based upon the Investigator’s clinical experience, the association of the event 
with the study drug seems likely.  


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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 
DEFINITE: The AE occurs following the application of the study drug and it cannot be 
reasonably explained by any other known characteristics of the patient’s clinical state, 
environmental or toxic factors, or other modes of treatment administered to the patient. It 
disappears or decreases upon discontinuation of the study medication and reappears on a 
re-challenge of the study drug. 
9.7.4 Patient’s Participation Stopping Criteria 
In the opinion of the Investigator, if the patient suffers an AE that warrants discontinuation of the 
study drug because of interference with age-appropriate instrumental ADL (Activities of Daily 
Living), for example preparing for meal, shopping for groceries or clothing, using the telephone, 
etc. the patient will be followed until the AE resolves or is considered stable. Any subject that 
discontinues the study because of an adverse event will be followed until resolution or 
stabilization of the adverse event. 
9.8 Serious Adverse Events 
9.8.1 Definition of a Serious Adverse Event 
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose suggests a 
medically significant hazard, including any event that: 
 
Results in death:  includes all deaths, even those that appear to be completely unrelated to 
study treatment (e.g., car accident where patient is a passenger). 
 
Is life-threatening:  in the view of the Investigator, the patient is at immediate risk of death at 
the time of the event. 
 
Results in persistent or significant disability or incapacity (substantial disruption of one’s 
ability to conduct normal life). 
 
Requires inpatient hospitalization or prolongation of existing hospitalization. 
 
Causes congenital anomaly or birth defect. 
 
Is an important medical event that may not be immediately life-threatening or result in death 
or hospitalization, but may jeopardize the patient or may require medical or surgical 
intervention to prevent one of the serious outcomes listed above (e.g., intensive treatment in 
an emergency room, convulsions that do not result in hospitalizations). Emergency Room 
visits that require medical or surgical intervention to prevent one of the other serious 
outcomes listed above are considered a Serious Adverse Event. 
9.8.2  Reporting Serious Adverse Events 
Investigator Reporting of SAEs 
Adverse events that are evaluated by the Investigator as "Serious" will be reported to the Sponsor 
and IRB within 24 hours of notice whether or not they are considered expected or drug-related. 
All SAEs will be reported as per applicable regulations. All SAEs encountered during the study 
will be reported on the appropriate form and summarized in the final report.  


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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Any serious or unexpected adverse events should be reported to Novum within 24 hours. 
Following is the contact information: 
Gail Gongas 
Vice President, Clinical Trials 
Cell Phone 412-606-1603 
Phone 412-363-3300 x 522 
Fax 412-291-3171 
Or 
Paolo Fanzio, MD 
Medical Monitor 
Phone 412-363-3300 x 597 
Fax 412-291-3171 
Novum will report any Serious Adverse Event to Taro.  
Documentation of serious or unexpected adverse events and follow-up information should be sent 
to Taro’s SAE Coordinator and Taro’s Drug Safety Manager within 24 hours from Novum being 
made aware of the SAE. Following is the contact information: 
Taro SAE Coordinator: 
 
Taro Drug Safety Manager: 
Danielle Simpson 
Coordinator, Clinical Operation 
Taro Pharmaceuticals USA Inc. 
Tel: 914-345-9001 ext.6234  
Email: danielle.simpson@taro.com  
 
Margo Wyatt, RN, BSN, 
Associate Director, Drug Safety 
Taro Pharmaceuticals U.S.A., Inc. 
Tel: 914-345-9001 Ext. 6758 
Email: margo.wyatt@taro.com and taropvus@taro.com  
 
The Sponsor must notify FDA of a fatal or life-threatening adverse event as soon as possible but 
no later than 7 calendar days from reporting the event by the Investigator. Investigators will be 
informed of any SAEs reported at other study sites within 15 days from the initial report.  
10.0 STATISTICAL METHODS 
10.1 Statistical Plan 
A Statistical Analysis Plan (SAP), detailing the intended statistical analysis of the study data, will be 
prepared as a separate document and finalized before database lock. Any deviation from the original 
statistical plan will be described and justified in the final report, as appropriate. The procedure for 
accounting for missing, unused and spurious data will be included in the Statistical Analysis Plan. 
All statistical analysis will be conducted using SAS®, Version 9.4 or higher.  
10.1.1 Determination of Sample Size 
The sample size of 5-10 evaluable patients was deemed appropriate to meet the objective of the 
study 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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10.1.2 Safety Analysis of Potential HPA Axis Suppression 
Dosing will be once daily for 28 days. Patients with normal adrenal function at baseline, use at 
least 21 doses of the study product and have data from a post-treatment cortisol response test will 
be included in the analysis. Patients who have not used 21 doses of the study product will be 
excluded from the primary analysis of HPA axis suppression. 
The primary analysis of interest is to assess the proportion of patients considered to have 
demonstrated possible HPA axis suppression following treatment with the study medication.  As 
a secondary analysis of the data a logistic regression of the proportion of patients in the study 
with HPA axis suppression will be performed with % scalp affected as a covariate. See Appendix 
D for results from the cortisol response test considered indicative of potential HPA axis 
suppression. 
For all patients the actual amount of desoximetasone (mg) applied during the study will be 
calculated from recorded bottle weights and presented. 
After the completion of 5 patients an interim analysis will be performed and presented. 
10.2 Safety Analysis 
Safety analysis will be conducted on all patients who applied at least one dose of study product. 
Adverse events will be classified using standard MedDRA terminology Version 19 or higher and 
summarized over all patients. Adverse events reported during the study will be tabulated in summary 
table listing by type, date of onset, date of resolution, incidence, severity, action taken, outcome and 
Investigator’s opinion of relationship to the study product will be prepared. Signs and symptoms of 
scalp psoriasis will not be considered adverse events, unless in the Investigator’s opinion, they have 
increased in frequency and/or severity to such an extent that the Investigator/patient considers that it 
is in the patient’s best interest to be dropped from continued participation in the study and given 
alternative therapy for their condition. 
Concomitant medication use during the study will be tabulated by patient. 
Ocular safety evaluations will be assessed at the discretion of the Investigator based on the findings of 
the HEENT exam performed at each visit along with the ocular discomfort reported by the patient. 
Ocular discomfort will be assessed by patients and reported to staff during clinic visits (Appendix C). 
Adverse medical events experienced by the patients will be tabulated. The relationship of AEs, if any, 
to the study product will be assessed by the Investigator. Adverse events assessed as definite, 
probable, possible or not related to the study drug will be presented. Shift analysis using the 
categories, below, above and within the laboratory normal range will be performed to identify any 
specific laboratory parameter that shows a trend toward potentially clinically significant changes. 
11.0 REGULATORY OBLIGATIONS 
11.1 Institutional Review Board 
The study protocol, informed consent/assent form, Investigator's Brochure, or package insert (as 
applicable), and any specific advertising will be submitted to, and approved by, an Institutional 
Review Board (IRB) before the start of the study. A form must be signed by the chairman or designee 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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of the IRB noting the approvals. This notification of the board's approval along with a description by 
profession and gender of the board's composition will be provided to the Sponsor. 
11.2 Study Documentation 
This study will be conducted in compliance with the protocol, Good Clinical Practices (GCPs) and all 
applicable regulations, including the Federal Food, Drug and Cosmetics Act, US applicable Code of 
Federal Regulations (title 21), parts 50, 56, 312, 320 and any IRB requirements relative to clinical 
studies and the Declaration of Helsinki, June 1964, as modified by the 64th World Medical 
Association General Assembly, October 2013.17-20 
The Investigator will permit trial-related monitoring, audits, IRB review and regulatory inspections 
providing direct access to source data/documents. 
11.2.1 Protocol  
The Investigator indicated on FDA Form 1572 will act as the Principal Investigator at each study 
site. Protocols will be noted as approved by placement of the Novum Representative’s signature 
on the cover page. The Sponsor of the study will also approve the protocol by having a study-
responsible individual sign the protocol cover page.  
11.2.2 Informed Consent 
An Informed Consent Form (ICF) that includes all of the relevant elements currently required by 
FDA and local State regulations will be provided to each prospective study patient before 
enrollment into the study. The type and method of study, tests to be administered, any potential or 
possible hazards, and the patient's right to withdraw from the study at any time will be explained 
to the patients by the Investigator or designee. Once the Investigator or designee is assured that an 
individual candidate understands the implications of participating in this study, the patient will be 
asked to give consent by signing and dating in the appropriate areas of the ICF. The Investigator 
or designee will also sign and date the form, along with a staff member who will sign the ICF as a 
witness to verify that the patient has indeed received information. For illiterate patients, verbal 
consent should be obtained in the presence of and be countersigned by a literate witness. If any 
other language is required, translation will be performed by a certified translator. A copy of the 
ICF will be provided to the patient.  
11.2.3 Protocol and Informed Consent Changes 
Revisions to the original protocol will be documented in amendments, incorporated as a preface 
to the new version and approved by the IRB. Any revision that substantially alters the study 
design or increases potential risk to the patient requires the patient’s consent to continue in the 
study. Revisions to the original ICF will also be approved by the IRB. The approvals will be 
processed in accordance with the established IRB procedures. Copies of all protocol and ICF 
amendments/revisions, along with letters noting IRB approval, will be submitted to the Sponsor. 
11.2.4 Source Documents and Case Report Forms 
All patients will be identified by initials, date of birth, and a unique patient number. Source 
documents will be used to record all study-related data. Source document entries will be used to 
complete Case Report Forms (CRFs). A set of CRFs will be completed for each patient enrolled 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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in the study. All data and CRFs will be reviewed, evaluated and signed by the Investigator, as 
required. 
The original source documents and a copy of the corresponding CRFs will be retained by the 
Investigator. Patients who terminate early from the study will have the end of study (Visit 3) 
source/CRF completed. 
11.2.5 Drug Accountability 
All drug receipt, inventory, dispensing, dosing and reconciliation records will be maintained in 
compliance with Federal Regulations. The study drug will be dispensed to qualified study patients 
according to established procedures. At the end of the study (after the database has been locked) 
all used and unused study drug will be returned to Novum. 
11.2.6 Drug Storage 
All study product will be stored at controlled room temperature 15-30°C (59-86ºF), in a secure 
place with access by authorized individuals only. The Investigator will be responsible for 
maintaining accurate records of product receipt, dispensing, and return. At the end of the study, 
all study product will be returned to Novum. 
11.2.7 Pregnancies 
Patients with a positive pregnancy test during screening will not be enrolled in the study. Patients 
who report that they have become pregnant during the study or have a positive pregnancy test at 
any clinic visit will be followed to completion of the pregnancy. The pregnancy will be reported 
as an AE. 
Female patients of childbearing potential must have been using and must agree to continue to use 
accepted methods of birth control, throughout the study. All female patients are considered to be 
of childbearing potential unless they are premenarchal, have been surgically sterilized or have 
been postmenopausal for at least 1 year. Abstinence is an accepted method of birth control. 
Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, 
contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., 
condom and spermicide) or IUD. Prior to study enrollment women of childbearing potential must 
be advised of the importance of avoiding pregnancy during study participation.  
A negative result of a urine pregnancy test having a minimum sensitivity of at least 25 mIU/ml 
for hCG should be obtained, prior to study participation. Pregnancy testing will be performed at 
Visits 1, 2 and 3 and the results of all pregnancy tests (positive or negative) will be documented. 
If following initiation of study treatment, it is subsequently discovered that a study patient is 
pregnant or may have been pregnant at the time of Investigational Product exposure, the 
Investigational Product will be permanently discontinued. The Principal Investigator must 
immediately notify the Medical Monitor of this event. Reporting timelines and Novum/Sponsor 
contact will be consistent with SAE reporting guidelines (see section 9.8.2 of the protocol), i.e., 
pregnancies will be reported to the Sponsor/Novum within 24 hours to the contacts listed in 
section 9.8.2. 


CONFIDENTIAL PROTOCOL 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment 
with Desoximetasone  0.25% shampoo(Taro Pharmaceuticals U.S.A., Inc.) in Patients with Scalp Psoriasis 
 
 
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Protocol-required procedures for study discontinuation and follow-up must be performed on the 
patient. Other appropriate pregnancy follow-up procedures should be considered if indicated. In 
addition, the Principal Investigator must report to the sponsor follow-up information regarding 
the course of the pregnancy, including perinatal and neonatal outcome. Infants should be 
followed for a minimum of eight weeks after birth. 
11.2.8 Reporting Safety Information to the IRB 
The Investigator must promptly report to the Investigator’s IRB all unanticipated problems 
involving risks to patients. This includes death from any cause and all serious adverse events 
occurring during the study, regardless of the assessed causality. 
11.2.9 Record Retention 
All drug accountability records, CRFs, source data and related regulatory documents must be 
retained for at least ten years following completion of the study or for two years after the test 
product has been approved for marketing by the Food and Drug Administration.  
11.2.10 Study Monitoring and Auditing 
Novum will be responsible for monitoring the study according to Good Clinical Practice and 
applicable regulations. Monitoring visits are for the purpose of confirming adherence to the 
protocol and to verify complete and accurate data collection. The clinical site will make all 
records associated with the study available to Novum’s representative during such visits and 
audits 
The study may be subject to audit by the Sponsor, Sponsor Representative or by regulatory 
authorities. If such an audit occurs the Investigator must agree to allow access to required patient 
records. By signing this protocol, the Investigator grants permission to personnel from the 
Sponsor, its representatives and appropriate regulatory authorities for on-site monitoring of all 
appropriate study documentation, as well as on-site review of study procedures. 
11.2.11 End of the Trial 
The end of the trial is defined as the time at which the last patient has completed their last visit in 
the study. Upon completion of the study, the study drug will no longer be available to the patient 
but the Investigator can, at their discretion, discuss alternative treatments with the patient. 
11.2.12 Clinical Study Report 
At the end of the study a full report in e-CTD format will be prepared that will include a narrative 
of the clinical conduct and results of the study, a statistical report including a description of the 
analysis performed, and other documentation as may be appropriate. 
 
 


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71615001 Rev. 1  June 28, 2016    Taro Pharmaceuticals U.S.A., Inc   Page 37 of 48 
 
 
 
12.0 REFERENCES 
1 
www.psoriasis.org. 
2 
National Clinical Guideline Centre, U. Assessment and management of psoriasis. NCGC 
Guideline (2012). 
3 
Jacob, S. Corticosteroid and Fragrance Allergy Exacerbating Scalp Psoriasis. The Journal of 
clinical and aesthetic dermatology 7, 54-55 (2014). 
4 
Bucolo, S. Head and Neck Psoriasis. Psoriasis, Dr. Jennifer Soung (Ed.), ISBN: 978-953-307-
878-6, IntechOpen (2012). 
5 
Luger, T. A. et al. A study of the safety and efficacy of calcipotriol and betamethasone 
dipropionate scalp formulation in the long-term management of scalp psoriasis. Dermatology 
217, 321-328, doi:10.1159/000155642 (2008). 
6 
Augustin, M. et al. Topical long-term therapy of psoriasis with vitamin D(3) analogues, 
corticosteroids and their two compound formulations: position paper on evidence and use in daily 
practice. Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society 
of Dermatology : JDDG 12, 667-682, doi:10.1111/ddg.12396 (2014). 
7 
Samarasekera, E. J., Sawyer, L., Wonderling, D., Tucker, R. & Smith, C. H. Topical therapies for 
the treatment of plaque psoriasis: systematic review and network meta-analyses. The British 
journal of dermatology 168, 954-967, doi:10.1111/bjd.12276 (2013). 
8 
Taro Pharmaceuticals. Package Insert for TOPICORT® (desoximetasone) Topical Spray, 0.25%.  
(2013). 
9 
FDA. Summary Basis of Approval - Luxiq (Betamethasone Valerate) Foam (NDA 20-934) - 
Connetics Corporation (1999). 
10 
Hengge, U. R., Ruzicka, T., Schwartz, R. A. & Cork, M. J. Adverse effects of topical 
glucocorticosteroids. Journal of the American Academy of Dermatology 54, 1-15; quiz 16-18, 
doi:10.1016/j.jaad.2005.01.010 (2006). 
11 
Product Label for TOPICORT®(desoximetasone) Topical Spray, 0.25%.  (April 2013). 
12 
Product Label for CortrosynTM Amphastar Pharmaceuticals, Inc.  August (2009). 
13 
Summary Basis of Approval OLUX® Clobetasol 0.05% Foam. NDA#021-142. Connetics.  May 
(2000). 
14 
Deparment of Health and Human Services, F.     (January 14, 2015). 
15 
Department of Health and Human Services, F. FDA Correspondence Advice Letter.  IND 
101789.  (April 27, 2015). 
16 
Olsen, E. A. et al. Alopecia areata investigational assessment guidelines--Part II. National 
Alopecia Areata Foundation. Journal of the American Academy of Dermatology 51, 440-447, 
doi:10.1016/j.jaad.2003.09.032 (2004). 
17 
World Medical Association Declaration of Helsinki: ethical principles for medical research 
involving human subjects. Jama 310, 2191-2194, doi:10.1001/jama.2013.281053 (2013). 
18 
FDA. 21CFR Part 50 Protection of Human Subjects. Department of Health and Human Services, 
Subchapter A-General 1 (2014). 
19 
FDA. 21CFR Part 56 Institutional Review Boards. Department of Health and Human Services, 
Subchapter A-General 1 (2014). 
20 
FDA. 21CFR 312.32: IND Safety Reporting.  (2010). 
 
 
 
 


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13.0 APPENDICES 
13.1 APPENDIX A 
 
Investigator Global Assessment (IGA) 
To be eligible for inclusion in the study the IGA must be 3 or 4 at baseline. Patients will be 
considered to have shown improvement in disease severity if the IGA score decreases by at least one 
unit from the baseline score, and will be considered a treatment success if the IGA score decreases at 
least 2 units from the baseline score. 
Score 
Category 
Description 
0 
Clear 
Plaque elevation: no evidence of plaque elevation above normal skin level 
Scaling: no evidence of scaling 
Erythema: no redness 
1 
Minimal 
Plaque elevation: very slight elevation above normal skin level, easier felt than 
seen 
Scaling: limited amount of very fine scales partially covers some of the plaques 
Erythema: very few of the plaques are light red 
2 
Mild 
Plaque elevation: slight but definite elevation above the normal skin level, 
typically with edges that are indistinct or sloped on some of the plaques 
Scaling: mainly fine scales, some plaques are partially covered 
Erythema: some plaques are light red 
3 
Moderate 
Plaque elevation: moderate elevation with rounded or sloped edges on most of 
the plaques 
Scaling: somewhat coarser scales; most plaques are partially covered 
Erythema: most plaques are red 
4 
Severe 
Plaque elevation: marked to very marked elevation, with hard to very hard sharp 
edges on virtually all or all of the plaques 
Scaling: coarse, thick scales; virtually all or all plaques are covered; rough 
surface 
Erythema: virtually all or all plaques are bright to dusky red 
 
 


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13.2 APPENDIX B 
Percent Scalp Affected 
Investigators will use the following chart to identify areas and estimate scalp surface area affected by 
psoriasis plaques.16 
 
 
 
 


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13.3 APPENDIX C 
Ocular Discomfort Assessment 
At Visits 2 and 3 the patient will be asked to assess if any ocular discomfort was experienced, YES or 
NO, since the last clinic visit. 
 
If YES is reported, the patient will be asked to report the signs and symptoms that apply from the list 
below or indicate any OTHER signs and symptoms experienced: 
 
Redness 
 
 
Stinging 
Itching 
 
 
Blur (decrease in vision) 
Pain 
 
 
Increased sensitivity 
Swelling 
 
 
Watery eyes 
Burning 
 
 
Spots, flashes and floaters 
Eye Discharge 
 
Foreign body sensation 
 
In addition, the patient will be asked to indicate if the shampoo came into contact with their eye, YES or 
NO, since the last clinic visit. If YES is reported, the patient will be asked to rate the discomfort at the 
time of contact as None, Mild, Moderate or Severe. 
 
 


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13.4 APPENDIX D 
Cortisol Response Test 
This cortisol release test is modified from the procedure of Wood et al as described in the Product 
Label for CortrosynTM (cosyntropin) for injection (Amphstar Pharmaceuticals, Inc.). 
 
The procedure is as follows: 
1. A single 5 ml blood sample should be taken as the basal sample. 
2. 0.25 mg (a single vial) of CortrosynTM (cosyntropin) should be reconstituted with 1.0ml of 0.9% 
sodium chloride injection USP injected intramuscularly. In patients under 3 years of age, 
0.125mg of CortrosynTM will be used.  
3. 30 minutes after the IM injection a second 5 ml blood sample should be obtained. The resulting 
two serum samples (at least 1 ml of serum in each) should be processed and labeled according to 
the instructions provided and sent the same day to ACM Global Laboratory for analysis of basal 
and post stimulated serum cortisol concentration. 
The resulting blood samples should be sent to ACM Global Laboratory for immediate testing.  
The test at the End of Study visit should not be performed if the patient dosed within 12 hours. 
A patient will be considered to have normal basal cortisol level and adrenal function if they meet all 
three criteria listed below under Normal. Failure to meet any of these criteria is indicative of 
abnormal adrenal function or potential HPA axis suppression. 
 
Cortisol Results 
Normal 
Abnormal 
Basal 
(pre CortrosynTM 
injection) 
≥ 5 mcg/100ml 
< 5 mcg/100ml 
30 minutes post 
CortrosynTM injection 
≥ basal value + 7 
< basal value + 7 
> 18 mcg/100ml 
≤ 18 mcg/100ml 
HPA Axis suppression will be defined as a 30 minute post CortrosynTM injection level cortisol level 
of ≤ 18 mcg/100ml. If the Visit 1 Cortisol Response Test shows signs of HPA axis suppression as 
defined above the patient will be contacted and instructed to discontinue the use of study product, not 
to initiate any new steroid therapy, topical or otherwise and an End of Study Visit will be scheduled 
to conduct a Cortisol Response Test at least 28 days after the initial Cortisol Response Test at Visit 1 
to assess for HPA axis suppression.  At Visit 3  the study treatment period will be over, any patients 
with results of HPA axis suppression will be advised not to initiate any new steroid therapy, topical or 
otherwise, and to return to the site in 28 days at which time they will be assessed for HPA axis 
suppression.  
Any patient presenting with symptoms of HPA axis suppression, such as nausea, headache, myalgia, 
fatigue or loose stool, will be referred to an endocrinologist. As an additional safety precaution, 
wristbands identifying the patient as someone suffering from adrenal suppression secondary to steroid   
withdrawal will be provided to alert medical personnel should any emergencies arise before adrenal 
function returns to normal.  


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If the results of the cortisol response test still show signs of HPA axis suppression 28 days after 
discontinuing therapy they will be asked to return in 28 days (56 days after discontinuing steroid 
therapy) for another follow-up test. If the patient is still showing signs of HPA axis suppression 56 
days after discontinuing steroid therapy and presents with related symptoms they will be referred to 
an endocrinologist.  
If HPA axis suppression persists for 56 days after discontinuing steroid therapy, but the patient has no 
symptoms they will be asked to return in 28 days (84 days after discontinuing steroid therapy) for 
another follow-up test. If HPA axis suppression persists for 84 days after discontinuing steroid 
therapy patients will be referred to an endocrinologist regardless of symptoms.  
Patients should not be subjected to CortrosynTM testing, or any other challenge to their adrenal 
response, any sooner than 4 weeks from their last CortrosynTM test.  
Follow-Up Schedule for Patients showing signs of HPA Axis Suppression 
Days 
after d/c 
HPA Results 
Symptom
s 
Patient Course 
28 
Normal 
N/A 
Study over 
28 
Abnormal 
Yes 
Refer to endocrinologist 
28 
Abnormal 
No 
Repeat test in 28 days 
56 
Normal 
N/A 
Study over 
56 
Abnormal 
Yes 
Refer to endocrinologist 
56 
Abnormal 
No 
Repeat test in 28 days 
84 
Normal 
N/A 
Study over 
84 
Abnormal 
Yes or No 
Refer to an endocrinologist 
 
 


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13.5 APPENDIX E 
Evaluation of HPA Axis Suppression 
Corticosteroid Effect on HPA Axis Feedback Loop 
 
 
 
Assessment of Corticosteroid Effect on HPA Axis Feedback Loop 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Hypothalamus secretes Corticotrophin 
Releasing Hormone (CRH) which triggers the 
anterior 
pituitary 
to 
release 
Adrenocorticotrophin 
Hormone 
(ACTH). 
ACTH stimulates the adrenal cortex to release 
glucocorticosteroids into the bloodstream. 
Increased levels of circulating glucocorticoids 
in the bloodstream send a signal to the 
hypothalamus to decrease the secretion of 
CRH and also to the anterior pituitary to 
decrease the secretion of ACTH resulting in a 
decrease in circulating glucocorticosteroids. 
Exogenous corticosteroids, including those 
absorbed systemically through the skin, may 
also impart a message to the hypothalamus  
and  anterior pituitary to decrease secretion of 
hormones.  This may result in decreased 
circulating glucocorticosteroids and thus, a 
decreased response to glucocorticosteroids. 
Low circulating cortisol levels or a decreased 
response to cortisol are indicative 
of 
suppression of the activity of the HPA axis. 
In order to evaluate the HPA axis function of 
patients in this study, basal levels of cortisol 
in the blood will be measured at the end of 
treatment. Patients will then be injected with 
CortosynTM, a synthetic subunit of ACTH. 
Systemic administration of a synthetic 
subunit of   ACTH   should   stimulate   the   
Adrenal 
Cortex 
to 
release 
glucocorticosteroids, unless the   patient   has   
had   increased   circulating levels of 
glucocorticosteroids for some time and the 
HPA axis has been suppressed. After 
30 minutes have  passed  blood  levels  of 
cortisol will be measured again. Lack of, or 
limited  release  of  glucocorticosteroids  into 
the blood stream in response to the 
administered 
CortosynTM 
will 
indicate 
suppression of HPA axis function. 


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13.6 APPENDIX F 
Clinical Laboratory Testing  
As part of the Screening Procedures and at Visit 3 (or early termination for randomized patients only) 
patients will have a blood sample taken for hematology and clinical chemistry testing. The testing 
panel should include as a minimum the following tests: 
Hematology 
 
Hematocrit  
 
White blood cell count 
 
Platelets 
 
Hemoglobin 
 
Red blood cell count  
 
Differential white cell count 
Chemistry 
 
Alkaline phosphatase  
 
Total bilirubin 
 
Alanine transaminase  
 
Creatinine 
 
Aspartate transaminase  
 
Glucose 
 
Blood urea nitrogen 
Clinical Laboratory Testing will be performed at a Central Laboratory 
ACM Medical Lab, Inc. 
160 Elmgrove Park 
Rochester, NY 14624, USA 


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13.7 APPENDIX G 
Cortrosyn™ Package Insert 
FOR DIAGNOSTIC USE ONLY 
CORTROSYN
TM
 
(cosyntropin) for Injection 
DESCRIPTION 
CORTROSYNTM (cosyntropin) for Injection is a sterile Iyophilized powder in vials containing 0.25 mg of CORTROSYNTM and 10 mg of mannitol to be 
reconstituted with 1 mL of 0.9% Sodium Chloride Injection, USP. Administration is by intravenous or intramuscular injection. Cosyntropin is α 1 - 24 corticotropin, a 
synthetic subunit of ACTH. It is an open chain polypeptide containing, from the N terminus, the first 24 of the 39 amino acids of natural ACTH. The sequence of 
amino acids in the 1 - 24 compound is as follows: 
 
 
CLINICAL PHARMACOLOGY 
CORTROSYNTM (cosyntropin) for Injection exhibits the full corticosteroidogenic activity of natural ACTH. Various studies have shown that the biologic activity of 
ACTH resides in the N-terminal portion of the molecule and that the 1 - 20 amino acid residue is the minimal sequence retaining full activity. Partial or complete 
loss of activity is noted with progressive shortening of the chain beyond 20 amino acid residues. For example, the decrement from 20 to 19 results in a 70% loss of 
potency. 
The pharmacologic profile of CORTROSYNTM is similar to that of purified natural ACTH. It has been established that 0.25 mg of CORTROSYNTM will 
stimulate the adrenal cortex maximally and to the same extent as 25 units of natural ACTH. This dose of CORTROSYNTM will produce maximal secretion of 17-
OH corticosteroids, 17- ketosteroids and / or 17 - ketogenic steroids. 
The extra-adrenal effects which natural ACTH and CORTROSYNTM have in common include increased melanotropic activity, increased growth hormone 
secretion and an adipokinetic effect. These are considered to be without physiological or clinical significance. 
Animal, human and synthetic ACTH (1-39) which all contain 39 amino acids exhibit similar immunologic activity. This activity resides in the C-terminal portion of the 
molecule and the 22-39 amino acid residues exhibit the greatest degree of antigenicity. In contrast, synthetic polypeptides containing 1-19 or fewer amino acids 
have no detectable immunologic activity. Those containing 1-26, 1-24 or 1-23 amino acids have very little immunologic although full biologic activity. This property 
of CORTROSYNTM assumes added importance in view of the known antigenicity of natural ACTH. 
 
INDICATIONS AND USAGE 
CORTROSYNTM (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. 
Because of its rapid effect on the adrenal cortex it may be utilized to perform a 30-minute test of adrenal function (plasma cortisol response) as an office or 
outpatient procedure, using only 2 venipunctures (see DOSAGE AND ADMINISTRATION section). 
Severe hypofunction of the pituitary - adrenal axis is usually associated with subnormal plasma cortisol values but a low basal level is not per se evidence of 
adrenal insufficiency and does not suffice to make the diagnosis. Many patients with proven insufficiency will have normal basal levels and will develop signs of 
insufficiency only when stressed. For this reason a criterion which should be used in establishing the diagnosis is the failure to respond to adequate corticotropin 
stimulation. When presumptive adrenal insufficiency is diagnosed by a subnormal CORTROSYNTM test, further studies are indicated to determine if it is primary 
or secondary. 
Primary adrenal insufficiency (Addison’s disease) is the result of an intrinsic disease process, such as tuberculosis within the gland. The production of 
adrenocortical hormones is deficient despite high ACTH levels (feedback mechanism). Secondary or relative insufficiency arises as the result of defective 
production of ACTH leading in turn to disuse atrophy of the adrenal cortex. It is commonly seen, for example, as result of corticosteroid therapy, Sheehan’s 
syndrome and pituitary tumors or ablation. 
The differentiation of both types is based on the premise that a primarily defective gland cannot be stimulated by ACTH whereas a secondarily defective gland is 
potentially functional and will respond to adequate stimulation with ACTH. Patients selected for further study as the result of a subnormal CORTROSYNTM test 
should be given a 3 or 4 day course of treatment with Repository Corticotropin Injection USP and then retested. Suggested doses are 40 USP units twice daily for 
4 days or 60 USP units twice daily for 3 days. Under these conditions little or no increase in plasma cortisol levels will be seen in Addison’s disease whereas 
higher or even normal levels will be seen in cases with secondary adrenal insufficiency. 
CONTRAINDICATION 


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The only contraindication to CORTROSYNTM (cosyntropin) for Injection is a history of a previous adverse reaction to it. 
 
PRECAUTIONS 
 
General 
CORTROSYNTM (cosyntropin) for Injection exhibits slight immunologic activity, does not contain animal protein and is therefore less risky to use than natural 
ACTH. Patients known to be sensitized to natural ACTH with markedly positive skin tests will, with few exceptions, react negatively when tested intradermally with 
CORTROSYNTM. Most patients with a history of a previous hypersensitivity reaction to natural ACTH or a pre-existing allergic disease will tolerate 
CORTROSYNTM. Despite this however, CORTROSYNTM is not completely devoid of immunologic activity and hypersensitivity reactions including rare 
anaphylaxis are possible. Therefore, the physician should be prepared, prior to injection, to treat any possible acute hypersensitivity reaction. 
 
Drug Interactions 
Corticotropin may accentuate the electrolyte loss associated with diuretic therapy. 
 
Carcinogenesis, Mutagenesis, Impairment of Fertility 
Long term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility. A study in rats noted inhibition of 
reproductive function like natural ACTH. 
 
Pregnancy 
Pregnancy Category C. Animal reproduction studies have not been conducted with CORTROSYNTM (cosyntropin) for Injection. It is also not known whether 
CORTROSYNTM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CORTROSYNTM should be given to a 
pregnant woman only if clearly needed. 
 
Nursing Mothers 
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 
CORTROSYNTM (cosyntropin) for Injection is administered to a nursing woman. 
 
Pediatric Use 
(See DOSAGE AND ADMINISTRATION section.) 
 
ADVERSE REACTIONS 
Since CORTROSYNTM (cosyntropin) for Injection is intended for diagnostic and not therapeutic use, adverse reactions other than a rare hypersensitivity 
reaction are not anticipated. A rare hypersensitivity reaction usually associated with a pre-existing allergic disease and/or a previous reaction to natural ACTH is 
possible. Symptoms may include slight whealing with splotchy erythema at the injection site. There have been rare reports of anaphylactic reaction. The following 
adverse reactions have been reported in patients after the administration of CORTROSYNTM and the association has been neither confirmed nor refuted: 
● bradycardia 
● tachycardia 
● hypertension 
● peripheral edema 
● rash 
 
DOSAGE AND ADMINISTRATION 
CORTROSYNTM (cosyntropin) for Injection may be administered intramuscularly or as a direct intravenous injection when used as a rapid screening test of 
adrenal function. It may also be given as an intravenous infusion over a 4 to 8 hour period to provide a greater stimulus to the adrenal glands. Doses of 
CORTROSYNTM 0.25 to 0.75 mg have been used in clinical studies and a maximal response noted with the smallest dose. 
 
A suggested method for a rapid screening test of adrenal function has been described by Wood and Associates (1). A control blood sample of 6 to 7 mL is 
collected in a heparinized tube. Reconstitute 0.25 mg of CORTROSYNTM with 1mL of 0.9% Sodium Chloride Injection, USP and inject intramuscularly. The 
reconstituted drug product should be inspected visually for particulate matter and discoloration prior to injection. Reconstituted CORTROSYNTM should not be 
retained. In the pediatric population, aged 2 years or less, a dose of 0.125 mg will often suffice. A second blood sample is collected exactly 30 minutes later. Both 
blood samples should be refrigerated until sent to the laboratory for determination of the plasma cortisol response by some appropriate method. If it is not possible 
to send them to the laboratory or perform the fluorimetric procedure within 12 hours, then the plasma should be separated and refrigerated or frozen according to 
need. 


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Two alternative methods of administration are intravenous injection and infusion. CORTROSYNTM can be injected intravenously in 2 to 5 mL of saline over a 2-
minute period. When given as an intravenous infusion: CORTROSYNTM, 0.25 mg may be added to glucose or saline solutions and given at the rate of 
approximately 40 micrograms per hour over a 6-hour period. It should not be added to blood or plasma as it is apt to be inactivated by enzymes. Adrenal response 
may be measured in the usual manner by determining urinary steroid excretion before and after treatment or by measuring plasma cortisol levels before and at the 
end of the infusion. The latter is preferable because the urinary steroid excretion does not always accurately reflect the adrenal or plasma cortisol response to 
ACTH. 
 
The usual normal response in most cases is an approximate doubling of the basal level, provided that the basal level does not exceed the normal range. Patients 
receiving cortisone, hydrocortisone or spironolactone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of cortisone 
or hydrocortisone on the test day and patients taking spironolactone or women taking drugs which contain estrogen may exhibit abnormally high basal plasma 
cortisol levels.  
A paradoxical response may be noted in the cortisone or hydrocortisone group as seen in a decrease in plasma cortisol values following a stimulating dose of 
CORTROSYNTM. 
In the spironolactone or estrogen group only a normal incremental response is to be expected. Many patients with normal adrenal function, however, do not 
respond to the expected degree so that the following criteria have been established to denote a normal response: 
 
1. The control plasma cortisol level should exceed 5 micrograms/100 mL. 
2. The 30-minute level should show an increment of at least 7 micrograms/100 mL above the basal level. 
3. The 30-minute level should exceed 18 micrograms/100 mL. Comparable figures have been reported by Greig and co-workers (2). 
 
Plasma cortisol levels usually peak about 45 to 60 minutes after an injection of CORTROSYNTM and some prefer the 60-minute interval for testing for this 
reason. While it is true that the 60-minute values are usually higher than the 30-minute values, the difference may not be significant enough in most cases to 
outweigh the disadvantage of a longer testing period. If the 60-minute test period is used, the criterion for a normal response is an approximate doubling of the 
basal plasma cortisol value. 
 
In patients with a raised plasma bilirubin or in patients where the plasma contains free hemoglobin, falsely high fluorescence measurements will result. The test 
may be performed at any time during the day but because of the physiological diurnal variation of plasma cortisol the criteria listed by Wood cannot apply. It has 
been shown that basal plasma cortisol levels and the post CORTROSYNTM increment exhibit diurnal changes. However, the 30-minute plasma cortisol level 
remains unchanged throughout the day so that only this single criterion should be used (3). 
 
Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. Reconstituted 
CORTROSYNTM should not be retained. 
 
HOW SUPPLIED  
Box of 10 vials of CORTROSYNTM (cosyntropin) for Injection 0.25 mg  
NDC # 0548-5900-00 
 
Storage 
Store at 15-30°C (59-86°F). 
CORTROSYNTM is intended as a single dose injection and contains no antimicrobial preservative. Any unused portion should be discarded. 
 
Rx only 
 
REFERENCES 
1. Wood, J.B. et al. LANCET 1.243, 1965. 
2. Greig, W.R. et al. J. ENDOCR 34.411, 1966. 
3. McGill, P.E. et al. ANN RHEUM DIS 26.123, 1967. 
 
Amphastar Pharmaceuticals, Inc. 
Rancho Cucamonga, CA 91730 U.S.A. REV. 9-05 
 
 


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13.8 APPENDIX H: 
Investigator Brochure, Desoximetasone 0.25% Shampoo 
 
Amendment 
Date 
 
1 
06/28/16 
The following revisions were made to the protocol Revision 0 dated 04/18/16: 
 
The percent scalp affected was changed to 20% 
 
Stopping criteria for HPA axis suppression was updated for patients with suppression at 
Visit 1 
 

SAP_001.pdf: 
NOVUM PHARMACEUTICAL RESEARCH SERVICES 
STATISTICAL ANALYSIS PLAN 
 
IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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STATISTICAL ANALYSIS PLAN 
 
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following 
Maximal Use Treatment with Desoximetasone 0.25% shampoo (Taro Pharmaceuticals U.S.A., 
Inc.) in Patients with Scalp Psoriasis 
 
 
Protocol Number: DSXS1538b 
Novum Study Number: 71615001 
 
 
Sponsor: 
Taro Pharmaceuticals U.S.A., Inc. 
3 Skyline Drive 
Hawthorne, NY 10532 
 
 
 
Contract Research Organization: 
Novum Pharmaceutical Research Services 
225 W. Station Square Drive, Suite 200 
Pittsburgh, PA 15219 
 
 
April 24, 2017 
Final Version 1.0 
 
 




NOVUM PHARMACEUTICAL RESEARCH SERVICES 
STATISTICAL ANALYSIS PLAN 
 
IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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Revision History 
VERSION 
DATE 
DESCRIPTION OF REVISIONS 
REVISED BY 
Draft 1.0 
April 18, 2017 
New Document 
Jianhua Liu 
Final 1.0 
April 24, 2017 
Finalize SAP 
Jianhua Liu 
 
 
 
 
  
 


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List of Abbreviations and Definition of Terms 
Abbreviation Term 
ADaM 
Analysis Data Model 
AE 
Adverse Event 
BP 
Blood Pressure 
C 
Celsius 
CRF  
Case Report Form 
CRO  
Clinical Research Organization 
CDISC 
Clinical Data Interchange Standards Consortium 
FDA  
Food and Drug Administration 
HR 
Heart Rate 
ICF  
Informed Consent Form 
ICH 
International Conference on Harmonization 
IGA 
Investigator’s Global Assessment 
IND 
Investigational New Drug  
ml 
Milliliter 
MedDRA 
Medical Dictionary for Regulatory Activities 
SAE  
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis System 
SDTM 
Study Data Tabulation Model 
 


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TABLE OF CONTENTS 
1. INTRODUCTION .......................................................................................................................7 
2. OBJECTIVES ..............................................................................................................................7 
3. OVERALL STUDY DESIGN .....................................................................................................7 
4. SAMPLE SIZE ..........................................................................................................................10 
5. STUDY ENDPOINTS AND ANALYSIS POPULATIONS ....................................................10 
6. STATISTICAL ANALYSIS METHODS .................................................................................10 
6.1 Baseline Characteristics .........................................................................................................10 
6.1.1 Demographics ................................................................................................................10 
6.1.2 Medical History .............................................................................................................11 
6.1.3 Physical Exam ...............................................................................................................11 
6.1.4 Percent Scalp Affected ..................................................................................................11 
6.1.5 Pregnancy Test ...............................................................................................................11 
6.1.6 Concomitant Medications ..............................................................................................12 
6.2 Statistical Analyses ................................................................................................................12 
6.2.1 Safety Analysis of Potential HPA Axis Suppression ....................................................12 
6.2.2 Investigator Global Assessment ....................................................................................12 
6.3 Safety Analysis ......................................................................................................................12 
6.3.1 Adverse Events ..............................................................................................................12 
6.3.2 Vital Signs .....................................................................................................................13 
6.3.3 Laboratory Evaluation ...................................................................................................13 
6.3.4 Ocular Discomfort Assessment .....................................................................................13 
6.4 Multiple Comparisons ...........................................................................................................14 
6.5 Methods for Handling Missing Data .....................................................................................14 
6.6 Interim Analyses ....................................................................................................................14 
7. TABLE, LISTING AND FIGURE SHELLS ............................................................................14 
T16.1.9.1 Summary of Patient Disposition .................................................................................16 
T16.1.9.2 Summary of Protocol Deviations  (Safety Population) ...............................................17 
T16.1.9.3 Summary of Demographic Data  (Safety Population) ................................................18 
T16.1.9.4 Summary of Frequency of HPA Axis Suppression at the End of Treatment .............19 
T16.1.9.5 Summary of Percent Scalp Affected with Plaque Psoriasis  (Safety Population) ......20 
T16.1.9.6 Summary of Frequency of Investigator Global Assessment (IGA) (Safety Population)21 
T16.1.9.7 Overall Summary of Adverse Events (Safety Population) .........................................22 
T16.1.9.8.1 Summary of Frequency of All Adverse Events by Body System  (Safety 
Population) ..................................................................................................................................23 
T16.1.9.8.2 Summary of Frequency of All Adverse Events in ≥ 2% of Patients by Body System  
(Safety Population) ......................................................................................................................23 
T16.1.9.9 Summary of Frequency of All Adverse Events by Severity (Safety Population) .......24 
T16.1.9.10 Summary of Frequency of All Adverse Events by Relationship (Safety Population)25 
T16.1.9.11 Summary of Frequency of Serious Adverse Events (Safety Population) .................26 


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T16.1.9.12 Shift Analysis of Clinical Chemistry Laboratory Results from Baseline to End of 
Treatment (Safety Population) ....................................................................................................27 
T16.1.9.13 Shift Analysis of Clinical Hematology Laboratory Results from Baseline to End of 
Treatment (Safety Population) ....................................................................................................27 
L16.2.1 Listing of Discontinued Patients ....................................................................................28 
L16.2.2 Listing of Protocol Deviations .......................................................................................29 
L16.2.3 Listing of Patients Excluded from Safety Analysis of Potential HPA Axis Suppression30 
L16.2.4.1 Listing of Demographic Data ......................................................................................31 
L16.2.4.2 Listing of Medical History ..........................................................................................32 
L16.2.4.3 Listing of Concomitant Medication ............................................................................33 
L16.2.5.1 Listing of Drug Administration ...................................................................................34 
L16.2.5.2 Listing of Study Medication Weight ...........................................................................35 
L16.2.6.1 Listing of Cortisol Response Test Results ..................................................................36 
L16.2.6.2 Listing of HPA Axis Suppression Follow-Up ............................................................37 
L16.2.6.3 Listing of Investigator Global Assessment (IGA) ......................................................38 
L16.2.6.4 Listing of Percent Scalp Affected with Plaque Psoriasis ............................................39 
L16.2.7 Listing of Adverse Events ..............................................................................................40 
L16.2.8.1 Listing of Positive Pregnancy Test Results .................................................................41 
L16.2.8.2 Listing of Vital Signs ..................................................................................................42 
L16.2.8.3 Listing of Abnormal Physical Examination Results ...................................................43 
L16.2.8.4 Listing of Clinical Hematology Laboratory Results ...................................................44 
L16.2.8.5 Listing of Clinical Chemistry Laboratory Results ......................................................45 
L16.2.8.6 Listing of Ocular Signs/Symptoms Assessment .........................................................46 
8. APPENDICES ...........................................................................................................................47 
APPENDIX A: Investigator Global Assessment (IGA) ..............................................................47 
APPENDIX B: Percent Scalp Affected .......................................................................................48 
APPENDIX C: Ocular Discomfort Assessment ..........................................................................49 
APPENDIX D: Cortisol Response Test ......................................................................................50 
APPENDIX F: Clinical Laboratory Testing ................................................................................52 
 


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IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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1. INTRODUCTION 
This Statistical Analysis Plan (SAP) is based on the final Clinical Study Protocol DSXS1538b 
(Study No. 71615001) Rev. 1 dated 06/28/2016. The SAP provides details on the planned 
statistical methodology for the analysis of the study data. The SAP also outlines the statistical 
programming specifications for the tables, listings and figures. 
 
This SAP describes the study endpoints, derived variables, anticipated data transformations and 
manipulations, and other details of the analyses not provided in the study protocol. This SAP 
therefore outlines in detail all other aspects pertaining to the planned analyses and 
presentations for this study. 
 
The following documents were reviewed in preparation of this SAP: 
 
 Clinical Study Protocol DSXS1538b (Study No. 71615001) Rev. 1 dated 06/28/2016 
 Case Report Form Booklet Version 1.0 for Study No. 71615001 (DSXS1538b) 
 
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. 
2. OBJECTIVES 
The objectives of this study are to: 
1. Evaluate the potential of desoximetasone 0.25% shampoo to suppress HPA axis function 
in patients with moderate to severe scalp psoriasis. 
2. Evaluate the efficacy parameters and adverse event (AE) profiles of desoximetasone 
0.25% shampoo administered to patients with moderate to severe scalp psoriasis. 
3. OVERALL STUDY DESIGN 
This open-label, safety study is designed to evaluate the potential for adrenal suppression after 
maximal use treatment with desoximetasone 0.25% shampoo (Taro Pharmaceuticals, U.S.A.), for 
the treatment of moderate to severe scalp psoriasis.  
Up to 5-10 eligible patients with stable plaque psoriasis of the scalp that satisfy all eligibility 
criteria will be enrolled into the study at Visit 1. Patients must be overall in good health. They 
should have a current diagnosis of moderate to severe scalp psoriasis with IGA score of at least 3 
or 4. 


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Patients enrolled in the study will apply product once daily for 28 days, according to provided 
instructions. Each patient is expected to receive 28 doses of study product. 
Patients will attend a total of 3 Clinic Visits and a telephone follow-up phone call (Visit 4) as 
follows: 
 Visit 1 (Day 1): Enrollment 
 Visit 2 (Day 14±2): Interim Visit  
 Visit 3 (Day 29 ± 2): End of Study or Early Termination  
 Visit 4 (Day 42± 4): Follow-up Telephone Phone Call  
The primary endpoint is the proportion of patients in the study with HPA axis suppression 
following treatment with the study medication. 
The safety profile of each treatment group will be evaluated by comparing adverse events. 
  
 
 


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IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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Study Schematic   
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Day 
1 
14 ± 2 
29 ± 2 
42 ± 4 
Procedures 
Screening/ 
Enrollment 
Before 12 pm 
Interim 
Visit 
End of 
Study/Early 
Termination 
Before 12 pm 
Telephone 
Follow-Up 
Visit 
Informed Consent 
X 
 
 
 
Medical History and 
Demographics 
X 
 
 
 
Vital Signs 
X 
X 
X 
 
Pregnancy Test* 
X 
X 
X 
 
Physical Exam 
X 
 
X 
 
HEENT Exam 
X 
X 
X 
 
% Scalp Affected 
X 
X 
X 
 
Investigator Global Assessment 
X 
X 
X 
 
Concomitant Medication 
X 
X 
X 
X 
Laboratory Evaluations 
X 
 
X 
 
Cortisol Response Test 
X 
 
X 
 
Confirm Inc/Exc Criteria 
X 
 
 
 
Dispense Wristband 
X 
 
 
 
Weigh and Dispense Study Product 
X 
X 
 
 
Collect and Weigh Study Product 
 
X 
X 
 
Dispense/Review Patient Diary 
X 
X 
X 
 
Ocular Assessment 
 
X 
X 
 
Adverse Events 
 
X 
X 
X 
Evaluation of Patient Compliance 
to the Protocol 
 
X 
X 
 
* Pregnancy test will be carried out for females of childbearing potential. 


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IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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4. SAMPLE SIZE 
The sample size of 5-10 evaluable patients was deemed appropriate to meet the objective of the 
study. 
5. STUDY ENDPOINTS AND ANALYSIS POPULATIONS 
Primary Outcome Measures:  
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence 
or presence of adrenal suppression at the end of treatment defined by the following criteria: 30 
minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml during the Cortisol 
Response Test. 
The primary endpoint is the proportion of patients in the study with HPA axis suppression 
following treatment with the study medication. 
Safety Population:  
Safety Population includes all patients who applied at least one dose of study drug. 
6. STATISTICAL ANALYSIS METHODS 
If not otherwise specified, statistical significance is defined as p<0.05 and is two-tailed. Data 
will be summarized with respect to demographic and baseline characteristics, efficacy variables 
and safety variables. 
 
For categorical variables, the number and percent of each category within a parameter will be 
calculated for non-missing data. For continuous variables, statistics will include number of 
observations, mean, standard deviation, median, minimum and maximum values.  
All statistical analyses will be conducted using SAS®, Version 9.4 or higher. Datasets will be prepared 
using headings from Clinical Data Interchange Consortium (CDISC) Study Data Tabulation Model 
(SDTM) implementation for human clinical trials and ADaM (Analysis Dataset Model).  
6.1 Baseline Characteristics 
6.1.1 Demographics 
Demographic information collected at baseline includes the following: 
 Age (years) 
 Gender (Male/Female) 


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IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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 Ethnicity (Hispanic/non Hispanic) 
 Race (White, Black/African American, Native Hawaiian or Other Pacific Islander, 
Asian, American Indian or Alaska Native, Other) 
Summary tables will be presented. Continuous variables will be summarized using descriptive 
statistics (n, median, minimum, maximum, mean, standard deviation). Categorical variables will 
be summarized using frequencies and percentages. 
All data will be listed by patient. 
6.1.2 Medical History 
At Visit 1, patients will be questioned about medical history, including acute and chronic 
medical history and medical history relevant to their scalp psoriasis. 
Medical history data will be listed by patient. 
6.1.3 Physical Exam 
A general physical exam will be conducted at Visit 1 and Visit 3. The physical exam must 
include a dermatological examination as a minimum. 
Abnormal physical exam results will be listed by patient and visit. 
6.1.4 Percent Scalp Affected 
Patient’s scalp will be examined by Investigator/designated clinician to determine the percent 
surface area affected with plaque psoriasis at all visits.  
Descriptive summary (n, mean, standard deviation, median, minimum, maximum) will be 
presented for percent scalp affected by visit.  
Percent scalp affected will be listed by patient and visit. 
6.1.5 Pregnancy Test 
Urine pregnancy tests on females of child-bearing potential will be performed at Visit 1, 2 and 3. 
 
Positive pregnancy test results will be listed by patient and visit. 


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6.1.6 Concomitant Medications 
At Visits 1-3 and during the telephone follow-up phone call (Visit 4) patients will be questioned 
about current and concomitant medication use over the previous 12 weeks. At all Interim Visits 
patients will be questioned about ongoing or new concomitant medication use. 
All prior and concomitant medications taken since screening will be listed by patient.  
6.2 Statistical Analyses 
6.2.1 Safety Analysis of Potential HPA Axis Suppression 
Dosing will be once daily for 28 days. Patients who have normal adrenal function at baseline, use 
at least 21 doses of the study product and have data from a post-treatment cortisol response test 
will be included in the analysis.  
The primary analysis of interest is to assess the proportion of patients considered to have 
demonstrated possible HPA axis suppression following treatment with the study medication.  
A logistic regression of the proportion of patients in the study with HPA axis suppression may be 
performed as exploratory analysis with % scalp affected as a covariate.  This will depend on the 
distribution of the % scalp data collected.  See Appendix D for results from the cortisol response 
test considered indicative of potential HPA axis suppression. 
6.2.2 Investigator Global Assessment 
Patient will be examined to determine the severity of scalp psoriasis based on a global 
assessment of plaque elevation, scaling and erythema by the Investigator/designated clinician. 
Investigator Global Assessment data will be summarized using frequency and percentage by 
visit. 
Investigator Global Assessment data will also be listed by patient and visit. 
6.3 Safety Analysis 
Safety analysis will be conducted on all patients who applied at least one dose of study drug. 
6.3.1 Adverse Events 
All the adverse events (AEs) reported throughout the study will be coded and classified 
according to the MedDRA (Medical Dictionary for Regulatory Activities Version 1 or higher) 
coding dictionary. Each adverse event is to be evaluated for date of start and end, seriousness, 
severity, causal relationship with the study drugs, action taken and outcome. 


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All AEs will be listed by patient. 
A summary table of the number and percent of patients with AEs by system organ class, 
preferred term will be presented. Each patient will be counted only once within each preferred 
term. 
A frequency summary table of the number of AEs by system organ class, preferred term, severity 
will be presented. Severity will be classified as “Mild”, “Moderate”, or “Severe”.  
Similarly, a frequency summary table of the number of AEs by system organ class, preferred 
term, and relationship to a study drug will be presented. Relationship to a study drug will be 
classified as “Not Related” or “Related” where “Related includes “Possible”, “Probable”, or 
“Definite”. 
6.3.2 Vital Signs 
The patient’s vital signs will be recorded (heart rate, blood pressure, temperature and respiration 
rate) at Visit 1, 2, and 3. 
 
Vital sign data will be listed by patient and visit. 
6.3.3 Laboratory Evaluation 
At Visit 1 and Visit 3 a blood sample will be collected for hematology and clinical chemistry 
testing. 
Shift analysis using the categories, below, above and within the laboratory normal range will be 
performed to identify any specific laboratory parameter that shows a trend toward potentially 
clinically significant changes. 
 
All data will be listed by patient and visit. 
6.3.4 Ocular Discomfort Assessment 
At Visits 2 and 3 the patient will be asked to assess if any ocular discomfort was experienced, 
YES or NO, since the last clinic visit. If YES is reported, the patient will be asked to report the 
signs and symptoms experienced. 
All data will be listed by patient and visit. 


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6.4 Multiple Comparisons 
No multiple comparison adjustment will be made in this study. 
6.5 Methods for Handling Missing Data 
For demographic and baseline characteristics, each variable will be analyzed using all available 
data. Patients with missing data will be excluded only from analyses for which data are not 
available. 
6.6 Interim Analyses 
There is no interim analysis planned in this study. 
7. TABLE, LISTING AND FIGURE SHELLS 
The following shells are provided in order to provide a framework for the display of data from 
this study. These shells may not be reflective of every aspect of this study but are intended to 
show the general layout of the Tables, Listings and Figures that will be included in the final 
clinical study report. Tables, Listings and Figures are numbered following the ICH structure. 
Table headers, variables names and footnotes will be modified as needed following data 
analyses. All descriptive and inferential statistical analyses will be performed using SAS® 
statistical software Version 9.4 or higher, unless otherwise noted. 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
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TABLE, LISTING AND FIGURE SHELLS 
 
 


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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.1 Summary of Patient Disposition 
Patients 
Total 
Enrolled 
xx 
Completed Study 
xx 
Terminated Early 
xx 
Adverse event  
xx 
Enrolled in error 
xx 
Lack of efficacy 
xx 
Lost to follow-Up 
xx 
Non-compliance with study drug 
xx 
Non-compliance with study procedure 
xx 
Restricted medication used for the treatment of psoriasis 
xx 
Restricted medication used for reasons other than the treatment of psoriasis 
xx 
Significant worsening of scalp psoriasis required alternative or supplemental therapy 
xx 
Withdrawal by subject  
xx 
Other 
xx 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
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___________________________________________________________________________________________________________ 
 
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T16.1.9.2 Summary of Protocol Deviations  
(Safety Population) 
 
Total 
Total Patients with Protocol Deviations 
xx 
Total Deviations 
xx 
Assessment conducted out of window 
xx 
Enrolled in error 
xx 
Lost to follow-up 
xx 
Missed blood collection 
xx 
Missed visit 
xx 
Outside visit window 
xx 
Non-compliance with study drug 
xx 
Non-compliance with study procedure 
xx 
Restricted medication use 
xx 
Study product not applied approximately 24 hours before clinic visit 
xx 
Other 
xx 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
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___________________________________________________________________________________________________________ 
 
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T16.1.9.3 Summary of Demographic Data  
(Safety Population) 
 
 
Total 
N=xx 
Age (years) 
n 
xx 
 
Mean ± SD 
xx.x ± xx.x 
 
Median 
xx.x 
 
Range 
xx.x – xx.x 
Race 
American Indian or Alaska Native 
xx (xx.x%) 
 
Asian 
xx (xx.x%) 
 
Black/African American 
xx (xx.x%) 
 
Native Hawaiian or other Pacific Islander 
xx (xx.x%) 
 
White 
xx (xx.x%) 
 
Other 
xx (xx.x%) 
Ethnicity 
Hispanic or Latino 
xx (xx.x%) 
 
Not Hispanic or Latino 
xx (xx.x%) 
Gender 
Female 
xx (xx.x%) 
 
Male 
xx (xx.x%) 
 
                                           N= number of patients; n= number of patients with data available; % is based on N 
 
 
                            Created on: ddmmmyy hh:mm 
Page 1 of N 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.4 Summary of Frequency of HPA Axis Suppression at the End of Treatment 
 
HPA Axis Suppression 
Total 
N=xx 
Yes 
No 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
N= number of patients included in HPA axis suppression analysis;  % is based on N 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.5 Summary of Percent Scalp Affected with Plaque Psoriasis  
(Safety Population) 
Visit 
n 
Mean 
SD 
Median 
Min 
Max 
1 
xx 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
2 
xx 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
3 
xx 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.6 Summary of Frequency of Investigator Global Assessment (IGA) 
(Safety Population) 
Visit 
0 (Clear) 
1 (Minimal) 
2 (Mild) 
3 (Moderate) 
4 (Severe) 
1 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
2 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
3 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
% is based on number of patients included in safety population. 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
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___________________________________________________________________________________________________________ 
 
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T16.1.9.7 Overall Summary of Adverse Events 
(Safety Population)  
Description 
Total 
N=xx 
Patients Randomized 
xx 
  Patients with at least one AE 
xx (xx.x%) 
  Discontinued study drug due to above AE 
xx (xx.x%) 
 
 
AEs reported 
xx 
  Mild 
xx (xx.x%) 
  Moderate 
xx (xx.x%) 
  Severe 
xx (xx.x%) 
  Not Related 
xx (xx.x%) 
  Related 
xx (xx.x%) 
  Death 
xx (xx.x%) 
  Serious AE 
xx (xx.x%) 
                                                       Related = Possible, Probable, Definite 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.8.1 Summary of Frequency of All Adverse Events by Body System  
(Safety Population) 
Body System 
MedDRA Term 
Events 
Patients 
Patients with at least one AE 
Total 
xx 
xx (xx.x%) 
Ear and labyrinth disorders 
Ear pain 
xx 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
% is based on number of patients included in safety population. 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
T16.1.9.8.2 Summary of Frequency of All Adverse Events in ≥ 2% of Patients by Body System  
(Safety Population) 
 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.9 Summary of Frequency of All Adverse Events by Severity 
(Safety Population)  
Body System 
MedDRA Term 
Mild 
Moderate 
Severe 
Patients with at least one AE 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Ear and labyrinth disorders 
Ear pain 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
% is based on number of patients included in safety population. 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.10 Summary of Frequency of All Adverse Events by Relationship 
(Safety Population)  
Body System 
MedDRA Term 
Related 
Not Related 
Patients with at least one AE 
Total 
xx (xx.x%) 
xx (xx.x%) 
Ear and labyrinth disorders 
Ear pain 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                    Related = Possible, Probable, Definite 
                    % is based on number of patients included in safety population. 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.11 Summary of Frequency of Serious Adverse Events 
(Safety Population)  
Body System 
MedDRA Term 
Total 
N=xx 
Injury, poisoning and procedural complications 
Alcohol poisoning 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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T16.1.9.12 Shift Analysis of Clinical Chemistry Laboratory Results from Baseline to End of Treatment 
(Safety Population) 
Alanine Aminotransferase (U/L) 
Baseline-> 
Endpoint 
Low 
Normal 
High 
 
Low 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
                                         % is based on number of patients included in safety population. 
 
Table will continue for other lab parameters. 
Similar table will be created for T16.1.9.13. 
 
T16.1.9.13 Shift Analysis of Clinical Hematology Laboratory Results from Baseline to End of Treatment 
(Safety Population) 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.1 Listing of Discontinued Patients 
Patient 
Number 
 
Date of  
Discontinuation 
Discontinuation 
Reason 
xx-xxxx 
yyyy-mm-dd 
Adverse event 
xx-xxxx 
yyyy-mm-dd 
Lost to follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.2 Listing of Protocol Deviations 
Patient 
Number 
Event Description 
xx-xxxx 
Outside Visit Window (Visit 3) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
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Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.3 Listing of Patients Excluded from Safety Analysis of Potential HPA Axis Suppression 
Patient 
Number 
Exclusion Reason 
xx-xxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.4.1 Listing of Demographic Data 
Patient 
Number 
Age 
Gender 
Ethnicity 
Race 
xx-xxxx 
30 
Female 
Not Hispanic or Latino 
Black or African American 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
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Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.4.2 Listing of Medical History 
Patient 
Number 
System 
Diagnosis or 
Surgical Procedure Start Date 
End Date 
Ongoing 
xx-xxxx 
Gynecologic 
Menopause 
yyyy-mm-dd 
yyyy-mm-dd 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.4.3 Listing of Concomitant Medication 
Patient 
Number 
Treatment 
Area 
Medication 
Dosage 
Frequency 
Route 
 
Location 
Start/End 
Date 
Indication 
xx-xxxx 
No 
Advil 
2 TAB 
QD 
Oral 
xxxxxxxxx 
yyyy-mm-dd / 
yyyy-mm-dd 
Cold 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.5.1 Listing of Drug Administration 
Patient 
Number 
Date of 
First Dose 
Date of 
Last Dose 
Total 
Doses Applied 
Compliance 
(%) 
xx-xxxx 
yyyy-mm-dd 
yyyy-mm-dd 
xx 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Note to programmer: 
Compliance = [Total number of applications] / [Planned number of applications] * 100%, where Planned number of applications is determined as follows:  
           for subjects who completed the study successfully: 28 applications (28 days of once daily dosing);  
           for subjects who discontinued early:  the minimum between 28 and [(Date of Discontinuation – Date of First Application)+1].  
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.5.2 Listing of Study Medication Weight 
Patient 
Number 
Bottle 1 
 
Bottle 2 
 
Total 
 Amount  
Applied 
(g) 
Weight  
Dispensed 
(g) 
Weight  
Collected 
(g) 
 
Weight  
Dispensed 
(g) 
Weight  
Collected 
(g) 
xx-xxxx 
xx 
xx 
 
xx 
xx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.6.1 Listing of Cortisol Response Test Results 
 
Patient 
Number 
 
 
Visit  
 
Was a Cortisol 
Response Test 
conducted? 
 
 
Date 
 
 
Basal Sample 
Draw Time  
 
 
Injection 
Time 
 
 
Post-
Injection 
Draw  
Time 
Basal  
Cortisol 
Concentration 
Level 
(mcg/100ml) 
Post Injection 
Cortisol 
Concentration 
Level 
(mcg/100ml) 
 
Have 
Abnormal 
Adrenal 
Function? 
 
 
 
HPA axis 
Suppression 
xx-xxxx 
1 
Yes 
yyyy-mm-dd 
hh:mm 
hh:mm 
hh:mm 
xxx 
xxx 
No 
No 
 
3 
Yes 
yyyy-mm-dd 
hh:mm 
hh:mm 
hh:mm 
xxx 
xxx 
Yes 
No 
xx-xxxx 
1 
Yes 
yyyy-mm-dd 
hh:mm 
hh:mm 
hh:mm 
xxx 
xxx 
No 
No 
 
3 
Yes 
yyyy-mm-dd 
hh:mm 
hh:mm 
hh:mm 
xxx 
xxx 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.6.2 Listing of HPA Axis Suppression Follow-Up  
 
Patient 
Number 
Is The Patient Showing Signs  
Or Symptoms Of HPA Axis 
Suppression?/ 
Was a  Cortisol Response  
Test Conducted? 
 
 
Follow-Up 
Test 
Date/ 
Basal Sample Draw Time/  
Injection Time/ 
Post-Injection Draw Time 
Basal 
Cortisol 
Concentration 
Level 
(mcg/100ml) 
Post Injection 
Cortisol 
Concentration 
Level 
(mcg/100ml) 
 
Still Show 
Signs of 
HPA Axis 
Suppression? 
 
Was the  
Patient Referred 
to an 
Endocrinologist 
xx-xxxx 
Yes/ Yes 
Test 1 
yyyy-mm-dd / hh:mm / 
hh:mm/ hh:mm 
xxx 
xxx 
No 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.6.3 Listing of Investigator Global Assessment (IGA) 
Patient 
Number 
Visit 1 
Visit 2 
Visit 3 / Early 
Termination 
xx-xxxx 
0 
0 
0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.6.4 Listing of Percent Scalp Affected with Plaque Psoriasis 
Patient 
Number 
Visit 1 
Visit 2 
Visit 3 / Early 
Termination 
xx-xxxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.7 Listing of Adverse Events 
Patient 
Number 
Body System / 
MedDRA Term / 
AE Term 
Treatment 
Area 
Start /End 
 Date 
Severity 
Relationship 
to Study 
Drug 
Outcome 
Action Taken/  
Other Action Taken SAE? 
xx-xxxx 
Nervous system disorders / 
Headache / 
Headache 
No 
yyyy-mm-dd / 
yyyy-mm-dd 
Mild 
Not Related 
Recovered Dose Not Changed/ 
None 
No 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
                    Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.8.1 Listing of Positive Pregnancy Test Results 
Patient  
Number 
Visit 1 
Visit 2 
Visit 3 
xx-xxxx 
Negative 
Negative 
Positive 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
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Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.8.2 Listing of Vital Signs 
Patient  
Number 
Visit 
Systolic BP 
(mmHg) 
 
Diastolic BP 
(mmHg) 
 
Heart Rate 
(beats/min ) 
 
Respiration Rate 
(breaths/min) 
 
Temperature 
(F) 
xx-xxxx 
1 
120 
70 
84 
18 
98.6 
 
2 
140 
80 
74 
18 
97 
 
3 
130 
87 
74 
18 
99.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.8.3 Listing of Abnormal Physical Examination Results 
Patient  
Number 
Visit 
System 
Results 
xx-xxxx 
1 
HEENT 
Abnormal (Scar) 
 
 
 
 
 
 
 
 
 
2 
 
 
 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
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___________________________________________________________________________________________________________ 
 
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L16.2.8.4 Listing of Clinical Hematology Laboratory Results 
Patient  
Number 
Visit 
Hematocrit 
(L/L) 
Basophils  
(10^9/L) 
Platelets  
(10^9/L) 
Hemoglobin 
(g/L) 
etc. 
xx-xxxx 
1 
xxx 
xxx 
xxx 
xxx 
xxx 
 
3 
xxx 
xxx 
xxx 
xxx (Low) 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
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IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.8.5 Listing of Clinical Chemistry Laboratory Results 
Patient  
Number 
Visit 
Alkaline 
Phosphatase 
(U/L) 
Alanine 
Transaminase 
(U/L) 
Aspartate 
Transaminase 
(U/L) 
Blood Urea 
Nitrogen 
(mmol/L) 
etc. 
xx-xxxx 
1 
xxx 
xxx 
xxx (High) 
xxx 
xxx 
 
3 
xxx 
xxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 
 
 


Taro Pharmaceuticals U.S.A., Inc. 
        Novum Pharmaceutical Research Services 
IND # 124879 Desoximetasone 0.25% Shampoo                                                     
Protocol/Study No. DSXS1538b/71615001 
___________________________________________________________________________________________________________ 
 
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L16.2.8.6 Listing of Ocular Signs/Symptoms Assessment 
Patient  
Number 
Visit 
Did the patient experience 
any ocular discomfort ? 
Signs/Symptoms the 
patient experienced 
Did the shampoo come 
into contact with the 
patient’s eyes? 
Patient’s overall 
discomfort 
xx-xxxx 
2 
Yes 
Redness/Pain 
Yes 
Mild 
 
3 
No 
 
 
 
xx-xxxx 
2 
Yes 
Itching/Pain 
Yes 
None 
 
3 
Yes 
Itching/Pain 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Created on: ddmmmyy hh:mm 
Page 1 of N 
 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
Desoximetasone 0.25% Shampoo  
 
 
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8. APPENDICES 
APPENDIX A: Investigator Global Assessment (IGA) 
To be eligible for inclusion in the study the IGA must be 3 or 4 at baseline. Patients will be 
considered to have shown improvement in disease severity if the IGA score decreases by at least 
one unit from the baseline score, and will be considered a treatment success if the IGA score 
decreases at least 2 units from the baseline score. 
Score 
Category 
Description 
0 
Clear 
Plaque elevation: no evidence of plaque elevation above normal skin level 
Scaling: no evidence of scaling 
Erythema: no redness 
1 
Minimal 
Plaque elevation: very slight elevation above normal skin level, easier felt 
than seen 
Scaling: limited amount of very fine scales partially covers some of the 
plaques 
Erythema: very few of the plaques are light red 
2 
Mild 
Plaque elevation: slight but definite elevation above the normal skin level, 
typically with edges that are indistinct or sloped on some of the plaques 
Scaling: mainly fine scales, some plaques are partially covered 
Erythema: some plaques are light red 
3 
Moderate 
Plaque elevation: moderate elevation with rounded or sloped edges on 
most of the plaques 
Scaling: somewhat coarser scales; most plaques are partially covered 
Erythema: most plaques are red 
4 
Severe 
Plaque elevation: marked to very marked elevation, with hard to very hard 
sharp edges on virtually all or all of the plaques 
Scaling: coarse, thick scales; virtually all or all plaques are covered; rough 
surface 
Erythema: virtually all or all plaques are bright to dusky red 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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APPENDIX B: Percent Scalp Affected 
Investigators will use the following chart to identify areas and estimate scalp surface area 
affected by psoriasis plaques.16 
 
 
 
 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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APPENDIX C: Ocular Discomfort Assessment 
At Visits 2 and 3 the patient will be asked to assess if any ocular discomfort was experienced, 
YES or NO, since the last clinic visit. 
If YES is reported, the patient will be asked to report the signs and symptoms that apply from the 
list below or indicate any OTHER signs and symptoms experienced: 
 
Redness 
 
 
Stinging 
Itching  
 
Blur (decrease in vision) 
Pain 
 
 
Increased sensitivity 
Swelling 
 
 
Watery eyes 
Burning 
 
 
Spots, flashes and floaters 
Eye Discharge  
Foreign body sensation 
 
In addition, the patient will be asked to indicate if the shampoo came into contact with their eye, 
YES or NO, since the last clinic visit. If YES is reported, the patient will be asked to rate the 
discomfort at the time of contact as None, Mild, Moderate or Severe. 
 
 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
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APPENDIX D: Cortisol Response Test 
This cortisol release test is modified from the procedure of Wood et al as described in the 
Product Label for CortrosynTM (cosyntropin) for injection (Amphstar Pharmaceuticals, Inc.). 
The procedure is as follows: 
1. A single 5 ml blood sample should be taken as the basal sample. 
2. 0.25 mg (a single vial) of CortrosynTM (cosyntropin) should be reconstituted with 1.0ml 
of 0.9% sodium chloride injection USP injected intramuscularly. In patients under 3 years 
of age, 0.125mg of CortrosynTM will be used.  
3. 30 minutes after the IM injection a second 5 ml blood sample should be obtained. The 
resulting two serum samples (at least 1 ml of serum in each) should be processed and 
labeled according to the instructions provided and sent the same day to ACM Global 
Laboratory for analysis of basal and post stimulated serum cortisol concentration. 
 
The resulting blood samples should be sent to ACM Global Laboratory for immediate 
testing.  
The test at the End of Study visit should not be performed if the patient dosed within 12 
hours. 
A patient will be considered to have normal basal cortisol level and adrenal function if 
they meet all three criteria listed below under Normal. Failure to meet any of these 
criteria is indicative of abnormal adrenal function or potential HPA axis suppression. 
 
Cortisol Results 
Normal 
Abnormal 
Basal 
(pre CortrosynTM 
injection) 
≥ 5 mcg/100ml 
< 5 mcg/100ml 
30 minutes post 
CortrosynTM 
injection 
≥ basal value + 7 
< basal value + 7 
> 18 mcg/100ml 
≤ 18 mcg/100ml 
HPA Axis suppression will be defined as a 30 minute post CortrosynTM injection level 
cortisol level of ≤ 18 mcg/100ml. If the Visit 1 Cortisol Response Test shows signs of 
HPA axis suppression as defined above the patient will be contacted and instructed to 
discontinue the use of study product, not to iniate any new steroid therapy, topical or 
otherwise and an End of Study Visit will be scheduled to conduct a Cortisol Response 
Test at least 28 days after the initial Cortisol Response Test at Visit 1 to assess for HPA 
axis suppression.  At Visit 3 the study treatment period will be over, any patients with 
results of HPA axis suppression will be advised not to initiate any new steroid therapy, 
topical or otherwise, and to return to the site in 28 days at which time they will be 
assessed for HPA axis suppression.  
Any patient presenting with symptoms of HPA axis suppression, such as nausea, 
headache, myalgia, fatigue or loose stool, will be referred to an endocrinologist. As an 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
Desoximetasone 0.25% Shampoo  
 
 
04/24/2017 
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additional safety precaution, wristbands identifying the patient as someone suffering from 
adrenal suppression secondary to steroid   withdrawal will be provided to alert medical 
personnel should any emergencies arise before adrenal function returns to normal.  
If the results of the cortisol response test still show signs of HPA axis suppression 28 days 
after discontinuing therapy they will be asked to return in 28 days (56 days after 
discontinuing steroid therapy) for another follow-up test. If the patient is still showing signs 
of HPA axis suppression 56 days after discontinuing steroid therapy and presents with related 
symptoms they will be referred to an endocrinologist.  
If HPA axis suppression persists for 56 days after discontinuing steroid therapy, but the 
patient has no symptoms they will be asked to return in 28 days (84 days after discontinuing 
steroid therapy) for another follow-up test. If HPA axis suppression persists for 84 days after 
discontinuing steroid therapy patients will be referred to an endocrinologist regardless of 
symptoms.  
Patients should not be subjected to CortrosynTM testing, or any other challenge to their 
adrenal response, any sooner than 4 weeks from their last CortrosynTM test.  
Follow-Up Schedule for Patients showing signs of HPA Axis Suppression 
Days 
after d/c 
HPA Results 
Symptom
s 
Patient Course 
28 
Normal 
N/A 
Study over 
28 
Abnormal 
Yes 
Refer to endocrinologist 
28 
Abnormal 
No 
Repeat test in 28 days 
56 
Normal 
N/A 
Study over 
56 
Abnormal 
Yes 
Refer to endocrinologist 
56 
Abnormal 
No 
Repeat test in 28 days 
84 
Normal 
N/A 
Study over 
84 
Abnormal 
Yes or No 
Refer to an endocrinologist 
 
 


IND # 124879                                                              Protocol/Study No. DSXS1538b/71615001 
Desoximetasone 0.25% Shampoo  
 
 
04/24/2017 
 Taro Pharmaceuticals U.S.A., Inc.  
Page 52 of 52 
APPENDIX F: Clinical Laboratory Testing  
As part of the Screening Procedures and at Visit 3 (or early termination for randomized patients 
only) patients will have a blood sample taken for hematology and clinical chemistry testing. The 
testing panel should include as a minimum the following tests: 
Hematology 
 Hematocrit  
 White blood cell count 
 Platelets 
 Hemoglobin 
 Red blood cell count  
 Differential white cell count 
Chemistry 
 Alkaline phosphatase  
 Total bilirubin 
 Alanine transaminase  
 Creatinine 
 Aspartate transaminase  
 Glucose 
 Blood urea nitrogen 
Clinical Laboratory Testing will be performed at a Central Laboratory 
ACM Medical Lab, Inc. 
160 Elmgrove Park 
Rochester, NY 14624, USA