Clinical trial NCT03000608
Conditions: Plaque Psoriasis
Sponsor: Santalis Pharmaceuticals, Inc.
Start date: 2017-05-17; Completion date: 2017-12-14
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will be a double-blind, multi-center, randomized, placebo controlled study to evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of mild-to-moderate plaque psoriasis.

Detailed description:
Patients will enter the Screening Period once the informed consent and photographic consent process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical treatment that covers a minimum of 1.0% and a maximum of 10% BSA, in the permitted treatment areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.

Once subject eligibility is confirmed and the screening procedures completed, all enrolled subjects will start the Treatment Period of the study. All enrolled subjects will receive either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice daily for 42 days.

Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28 and a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be queried for condition status since going off study.

Arms: arm 1: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily. arm 2: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
Interventions: intervention 1: SAN021 Serum intervention 2: SAN021 Placebo
Intervention descriptions: intervention 1: SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily. intervention 2: SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Protocol documents:
Prot_000.pdf: 
Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
1 | 10 
SANTALIS PHARMACEUTICALS 
Inclusion Criteria 
Subjects will be included in the trial if they meet all of the following 
Title 
A Multi-Center, Randomized, Placebo Controlled, Safety, 
Tolerability, and Efficacy Trial of a New Botanical Drug Product 
Containing East Indian Sandalwood Oil (EISO) at One Dose Level 
for the Treatment of Mild-to-Moderate Plaque Psoriasis in Adult 
Subjects 
Setting and Trial 
Center 
This trial will be conducted at approximately 5 study centers in the 
United States. 
Number of Subjects 
Up to 72 to ensure 60 complete the trial 
Objectives 
The objectives of this trial are: 
•
To evaluate the safety of SAN021 when administered to adult
subjects with mild-to-moderate plaque psoriasis
•
To evaluate the tolerability of SAN021 when administered to
adult subjects with mild-to-moderate plaque psoriasis
•
To evaluate the preliminary efficacy of SAN021 when
administered to adult subjects with mild-to-moderate plaque
psoriasis
Trial Design and 
Patient Population 
This trial will be a multi-center, randomized, placebo controlled 
study to evaluate the safety, tolerability, and efficacy of SAN021 
when administered for up to 42 days to adults between the ages 
of 18 to 65 years who have a clinical diagnosis of mild-to-
moderate plaque psoriasis.  
Subjects will enter the Screening Period once the informed 
consent and consent process has been completed. Subjects with 
mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area 
and Severity Index (PASI) score between 2 and 12,36 appropriate 
for topical treatment that covers a minimum of 1.0% and a 
maximum of 10% BSA, in the permitted treatment areas, and who 
meet all of the inclusion and none of the exclusion criteria will be 
enrolled.  
Once patient eligibility is confirmed and the screening procedures 
completed, all enrolled subjects will start the Treatment Period of 
the study.  All enrolled subjects will receive either 10% SAN021 or 
placebo serum (randomized in a 2:1 ratio) with the first dose 
applied at the Day 1 Study Visit. Subjects will be instructed on 
how to apply the study medication twice daily for 42 days.  
Subjects will return to the clinic for study-related assessments on 
Study Days 8, 15, 28 and a final visit on Day 42. On Study Day 
49, patient will receive a Follow-up phone call and be queried for 
condition status since going off study. 


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
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SANTALIS PHARMACEUTICALS 
criteria: 
1. Are ≥18 but ≤65 years of age
2. Have a clinical diagnosis of mild-to-moderate plaque
psoriasis, as defined by a Psoriasis Area and Severity Index
(PASI) score between 2 and 12,36 appropriate for topical
treatment that covers a minimum of 1.0% and a maximum of
10% BSA, in the permitted treatment areas.
3. Are willing to treat all psoriasis occurring in the permitted
treatment areas with only SAN021
4. Are free of any systemic or dermatologic disorder, which, in
the opinion of the investigator, will interfere with the study
results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment
area to ultraviolet radiation (natural or artificial) for the
duration of the study.
6. Are willing to refrain from using any lotions, moisturizer,
cleansers, cosmetics or creams, other than those issued as
part of the study, on the treatment areas during the
treatment period.
7. If female of childbearing potential, must be willing to practice
an acceptable form of birth control for the duration of the
study.(i.e. oral contraceptive, barrier method and/or intra-
uterine device)
8. Are able to give written informed consent in a manner
approved by the Institutional Review Board or Ethics Review
Committee and comply with the requirements of the study.
9. Are willing to avoid participation in any other clinical trial for
the duration of this study.
10. Are willing to refrain from treating restricted areas, which
will be excluded from PGA assessment and BSA calculation.
These areas are as follows: head, neck, fingernails, toenails,
soles of feet, and palms of hands, axillae, or intertriginous
areas.


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
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SANTALIS PHARMACEUTICALS 
Exclusion Criteria 
Subjects will be excluded from the trial if they meet any of the 
following criteria: 
1.
Have spontaneously improving or rapidly deteriorating
plaque psoriasis, or pustular psoriasis as determined by the
Investigator.
2.
Have been treated, with prescription medication for plaque
psoriasis, within 60 days prior to the Baseline visit.
3.
Are pregnant, breast-feeding, or planning to become
pregnant during the study.
4.
Have any evidence of systemic cancer, squamous cell
carcinoma, basal cell carcinoma, in the past 5 years, or any
other confounding skin condition.
5.
Are undergoing treatments with topical antipsoriatic drug
products other than corticosteroids within 14 days prior to
the Baseline Visit, and for therapy containing
corticosteroids or retinoids within 28 days prior to Baseline
Visit.
6.
Have open sores or open lesions in the treatment area(s).
7.
Have any condition that, in the opinion of the investigator,
would confound the safety and/or efficacy assessments of
plaque psoriasis.
8.
Have participated in any interventional clinical trial in the
previous 30 days.
9.
Have a known sensitivity to any of the constituents of the
test product including sensitivities to sandalwood oil,
fragrances, or any member of the Compositae family of
vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
10. Have used, are using, or are planning to use
immunosuppressive or immunomodulatory medication (i.e.,
biologics), including oral or parenteral corticosteroids.
11. Have a history of alcohol or illegal drug/substance abuse,
or suspected alcohol or illegal drug/substance abuse in the
past two years.
12. Plan to seek alternative treatment of any kind for their
psoriasis, in the eligible treatment areas or otherwise,
during the trial period.


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
4 | 10 
SANTALIS PHARMACEUTICALS 
Screening (Day -7) 
Eligible subjects will be asked to read and sign an informed 
consent and photography consent form.  No study procedures will 
be conducted until the informed consent and photography consent 
forms are signed.   
At the Screening Visit, the following procedures will be performed: 
▪
Conduct the informed/photography consent process.
▪
Record Demographics to include age, sex, and race.
▪
Review the inclusion/exclusion criteria.
▪
Record all concomitant medications including all
prescription drugs, nonprescription drugs, and nutritional
supplements taken in the 60-days prior to Screening.
▪
Perform a full physical examination including height (cm)
and weight (kg).
▪
Record pertinent medical history including tobacco, illegal
substance and alcohol history and current use.
▪
Administer the Physician’s Global Assessment (PGA) and
the Psoriasis Area Severity Index (PASI).
▪
Calculate the plaque BSA of the area(s) to be treated.
Treatment Period 
Visit 1 Baseline (Day 1 [±2 Days]) 
Eligible subjects will have the following procedures completed at 
Visit 1 (Baseline). It is possible for the patient to be screened and 
complete the Visit 1 (Baseline) procedures on the same day. 
▪
Review inclusion and exclusion criteria to ensure the
patient qualifies for the study.
▪
If this visit is NOT combined with the screening visit:
o
Perform an abbreviated physical examination
including weight (kg),
o
Update concomitant medications including all
prescription drugs, non-prescription drugs and
nutritional supplements
o
Review and update the patient’s pertinent medical
history.


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
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SANTALIS PHARMACEUTICALS 
o
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including
calculating the BSA of the affected area (only
treatment area(s) are to be evaluated).
▪
If patient is a female of childbearing potential, collect a
urine sample and perform a β-human chorionic
gonadotropin pregnancy test.
▪
Instruct the patient on proper washing of the target
treatment area(s) (using only study-approved cleanser) and
application of SAN021 study medication on the treatment
areas during the treatment period.
▪
Photograph the treatment area(s).
▪
Replace the cap with the dropper cap and weigh full bottle
of SAN021 study medication and record weight prior to on
site first dose.
▪
With the dropper cap on, weigh bottle of SAN021 study
medication post on site dose and dispense to subject.
▪
Instruct the subject to return in one week for the next study
visit with the study drug
Visit 2 (Day 7 [±2 Days]), Visit 3 (Day 14 [±2 Days]), Visit 4 (Day 
28 [±2 Days]) 
All study visits have a ±2-day visit window. 
▪
Query for adverse events.
▪
Update concomitant medications including all prescription
drugs, nonprescription drugs, and nutritional supplements.
▪
Query for treatment regimen compliance.
▪
Weigh and record the weight of the study medication and
re-dispense.
▪
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including calculating
the BSA of the affected area (only treatment area(s) are to
be evaluated).
▪
Photograph the treatment area(s).
▪
Review the directions for use of the study medication with
the patient, and re-educate if applicable.


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
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SANTALIS PHARMACEUTICALS 
▪
Instruct the patient to return for the next study visit with
study drug.
Final Visit (Visit 5) 
Final Visit (Day 42 [±2 Days]) 
▪
Query for adverse events.
▪
Update concomitant medications including all prescription
drugs, nonprescription drugs, and nutritional supplements.
▪
Query for treatment regimen compliance.
▪
Collect and weigh the study medication and record the
weight.
▪
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including calculating
the BSA of the affected area (only treatment area(s) are to
be evaluated).
▪
Photograph the treatment area(s).
▪
Instruct the patient to return for another study visit only if
study-related adverse events persist or, in the Investigator’s
opinion, an additional study visit is warranted to ensure the
patient’s safety.
Follow-up Call 
Follow-up Call (Day 49 [±2 Days]) 
•
Query for status of condition since going off study
o
i.e. has the condition been stable, worsened or
improved since discontinuing study medication?
Duration of Treatment 
and Trial Participation 
The maximum duration of trial participation for each patient is 
approximately 49 days: 
•
7-day Screening Period (Day -7)
•
Single-day Baseline Visit 1 (Day 1)
•
42-days of treatment (Visits 2 (Day 7), Visit 3 (Day 14),
Visit 4 (Day 28) and Final Visit (Day 42)
•
Follow-up Call (Day 49)
If the patient’s treatment is interrupted by illness or other 


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
7 | 10 
SANTALIS PHARMACEUTICALS 
circumstances, every attempt will be made to have the patient 
return to the clinic for a final visit. 
Trial Population 
Up to 72 subjects, 18 – 65 years of age inclusive, with a clinical 
diagnosis of mild-to-moderate plaque psoriasis, as defined by a 
Psoriasis Area and Severity Index (PASI) score between 2 and 
12,36 that, in the opinion of the investigator, is appropriate for 
topical treatment, that covers a minimum of 1.0% and a maximum 
of 10% BSA, in the permitted treatment areas. 
Trial Drug, Dose and 
Mode of 
Administration 
Study medication will be provided by Santalis Pharmaceuticals. 
The following treatment product will be provided: 
▪
SAN021 10%  - to be used morning and night,
 OR 
▪
Placebo- to be used morning and night.
Subjects will also be provided with: 
▪
Cetaphil Gentle Skin Cleanser - to be used for the
duration of the trial.
The first treatment of SAN021 will be applied at the Baseline Visit, 
then patient will be instructed on the procedure for self-
administration at home. 
Criteria For Evaluation 
Subjects that receive one application of study medication will be 
included in the safety and tolerability analysis. 
Subjects that complete at least 80% of treatments, as determined 
by product usage, will be included in the efficacy analysis. 
Missing efficacy data will be imputed using the last observation 
carried forward.  No imputations will be made for missing safety 
data. 
Safety Evaluations 
The primary purpose of this study is to determine the safety profile 
of SAN021. 
Safety will be assessed by evaluating adverse events (AEs) with 
respect to severity, duration, and relationship to study drug.     
Tolerability 
Evaluations 
Tolerability will be based on the number of subjects reporting 
discomfort during or immediately following application of SAN021, 
This will also be recorded as an AE. The study restricted treatment 


Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
CONFIDENTIAL 
8 | 10 
SANTALIS PHARMACEUTICALS 
areas are to be not to be used in this evaluation. (see #10 under 
Inclusion Criteria) 
Preliminary Efficacy 
Evaluation 
Preliminary Efficacy Endpoints: 
The preliminary efficacy will be evaluated as follows: 
▪
Percentage of subjects achieving at least a 1-grade
improvement in PGA score
▪
Percentage of subjects achieving a 2-grade improvement in
the PGA score
▪
Percentage of subjects who have a ≥ 25% reduction in the
Psoriasis Area and Severity Index (PASI) score at any point
during the trial.
▪
Percentage of subjects who have a ≥50% reduction in the
Psoriasis Area Severity Index (PASI) score at any point
during the trial.
▪
Number of subjects achieving a Physician’s Global
Assessment of “clear” or “almost clear” at any time point
during the 42 days of therapy. The study restricted
treatment areas are not to be included in this evaluation.
(see #10 under Inclusion Criteria)
A. Physician’s Global Assessment (PGA): The PGA will be based
on a 5-point scale ranging from 0 (clear) to 4 (severe), and will be 
assessed, preferably by the same evaluator at each visit for the 
overall affected areas with plaque psoriasis which were treated 
with the study drug. The study exclusion areas and those areas not 
treated are not to be used in this assessment. The following scores 
will be used to describe the severity of overall plaque psoriasis of 
the treatable areas: 
Grade 
Score 
Description 
Clear 
0 
No signs of psoriasis (post-inflammatory 
hyperpigmentation may be present) 
Almost 
Clear 
1 
Intermediate between mild and clear 
Mild 
2 
Slight scaling plaque elevation, scaling, and/or erythema 
Moderate 
3 
Moderate plaque elevation, scaling, and/or erythema 
Severe 
4 
Very marked plaque elevation, scaling, and/or erythema 


Clinical Study Protocol No. SAN021-03 
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Version 3.0 
08 August 2017 
CONFIDENTIAL 
9 | 10 
SANTALIS PHARMACEUTICALS 
Data Analysis 
Safety  
The number and percentage of subjects reporting at least one 
occurrence of an AE for each unique System Organ Class and 
Preferred Term will also be tabulated by severity and by the 
relationship to trial drug.  All AEs will be presented in a data listing. 
Tolerability 
Tolerability will be based on the number of subjects reporting 
discomfort during or immediately following application of SAN021, 
this will also be recorded as an AE.  
Preliminary Efficacy 
The efficacy will be assessed as follows: 
▪
Percentage of subjects achieving at least a 1-grade
improvement in PGA score
▪
Percentage of subjects achieving a 2-grade improvement in
the PGA score
▪
Percentage of subjects who have a ≥ 25% reduction in the
Psoriasis Area and Severity Index (PASI) score at any point
during the trial.
▪
Percentage of subjects who have a ≥50% reduction in the
Psoriasis Area Severity Index (PASI) score at any point
during the trial.
▪
Number of subjects achieving a Physician’s Global
Assessment of “clear” or “almost clear” at any time point
during the 42 days of therapy. The study restricted
treatment areas are not to be included in this evaluation.
(see #10 under Inclusion Criteria)
Planned Dates of 
Study 
April 2017 to December 2017 


Clinical Study Protocol No. SAN021-03 
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SANTALIS PHARMACEUTICALS 
Trial Contacts 
Name 
Affiliation / Address 
Responsibility 
Santalis 
Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA     
+1 (210) 558-8896
+1 (210) 694-9466
Sponsor 
Dr. Paul Castella, PhD Santalis Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA 
+1 (210) 558-8896
+1 (210) 694-9466
e-mail: paul@santalispharma.com
Sponsor 
Representative 
Somer Baburek 
Santalis Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA 
+1 (210) 399-2322
+1 (210) 694-9466
e-mail: somer @ santalispharma.com
Sponsor – Study 
Manager 

SAP_001.pdf: 
Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
 
 
    
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
Santalis Pharmaceuticals 
 
Protocol: SAN021-03 
 
A DOUBLE BLIND, MULTI-CENTER, RANDOMIZED, PLACEBO CONTROLLED 
SAFETY, TOLERABILITY AND EFFICACY TRIAL OF A NEW BOTANICAL DRUG 
PRODUCT CONTAINING EAST INDIAN SANDALWOOD OIL (EISO) AT ONE DOSE 
LEVEL FOR THE TREATMENT OF MILD-TO-MODERATE PLAQUE PSORIASIS IN 
ADULT SUBJECTS 
 
Author:                                       Julie Mordaunt 
 
Document status:                        Final 
Version dates:                             20DEC2017


Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
FINAL 20DEC2017 
 
     Page ii 
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..................................................................................................... 1 
 
STUDY INTRODUCTION ................................................................................................. 2 
1.1 
Study Objectives ........................................................................................................... 2 
1.1.1 
Primary Objectives .................................................................................................. 2 
1.1.2 
Additional Objectives .............................................................................................. 2 
 
STUDY DESIGN .................................................................................................................. 2 
2.1 
Overview of Study Design ........................................................................................... 2 
2.2 
Sample Size .................................................................................................................. 3 
 
ANALYSIS POPULATIONS ............................................................................................. 3 
3.1 
Safety Analysis Set ....................................................................................................... 3 
3.2 
Full Analysis Set........................................................................................................... 3 
3.3 
Per Protocol Analysis Set ............................................................................................. 3 
3.4 
Other Analysis Sets ...................................................................................................... 4 
 
STATISTICAL METHODS OF ANALYSIS ................................................................... 4 
4.1 
Statistical Considerations ............................................................................................. 4 
4.1.1 
Quantitative Assessments ........................................................................................ 4 
4.1.2 
Qualitative Assessments .......................................................................................... 4 
4.2 
Methods for Handling Missing Data ............................................................................ 4 
 
EVALUATION OF SUBJECT DISPOSITION AND EXPOSURE ............................... 4 
5.1 
Subject Disposition ....................................................................................................... 4 
5.2 
Study Product and Visit Compliance ........................................................................... 5 
 
EVALUATION OF BASELINE CHARACTERISTICS ................................................. 5 
6.1 
Demographics ............................................................................................................... 6 
6.2 
Baseline Disease Characteristics .................................................................................. 6 
6.3 
Medical History/Signs and Symptoms ......................................................................... 6 
 
EVALUATION OF SAFETY PARAMETERS ................................................................ 6 
7.1 
Adverse Events ............................................................................................................. 6 
7.2 
Treatment Tolerability .................................................................................................. 7 
7.3 
Prior and Concomitant Medication/Therapy ................................................................ 7 
 
EVALUATION OF EFFICACY PARAMETERS ........................................................... 7 


Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
FINAL 20DEC2017 
 
     Page ii 
8.1 
Physician’s Global Assessment .................................................................................... 7 
8.2 
Psoriasis Area and Severity Index ................................................................................ 8 
8.3 
Body Surface Area ....................................................................................................... 9 
8.4 
Post Study Status .......................................................................................................... 9 
 
CONVENTIONS FOR CALCULATIONS AND TABULATIONS ............................... 9 
  SPECIFICATIONS FOR ANALYSIS DISPLAYS .......................................................... 10 
10.1  Format .......................................................................................................................... 10 
10.1.1 
Conventions for Tables ........................................................................................... 10 
10.1.2 
Conventions for Listings ......................................................................................... 11 
10.2  Summary Tables to be Provided................................................................................... 12 
10.3  Listings to be Provided ................................................................................................. 13 
 


Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
FINAL 20DEC2017 
 
    Page 1 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
cm 
centimeter 
eCRF 
Electronic Case Report Form 
EISO 
East Indian Sandalwood Oil 
FAS 
Full Analysis Set 
g 
gram 
ITT 
Intent-to-Treat 
kg 
kilogram 
MedDRA 
Medical Dictionary for Regulatory Activities 
N 
population size (N for sample size, n for available data) 
PASI 
Psoriasis Area and Severity Index 
PGA 
Physician’s Global Assessment 
PP 
Per Protocol 
PT 
Preferred Term 
SD 
Standard Deviation 
SOC 
System Organ Class 
TEAE 
Treatment Emergent Adverse Event 
Note: The first occurrence of some abbreviations is not spelled out in the document (e.g. units of 
measure). 


Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
FINAL 20DEC2017 
 
     Page 2 
 
STUDY INTRODUCTION 
This statistical analysis plan is based on the protocol “A Double Blind, Multi-Center, Randomized, 
Placebo Controlled Safety, Tolerability, and Efficacy Trial of a New Botanical Drug Product 
Containing East Indian Sandalwood Oil (EISO) at One Dose Level for the Treatment of Mild-to-
Moderate Plaque Psoriasis in Adult Subjects”, dated 08 August 2017.  
1.1 
Study Objectives 
1.1.1 
Primary Objectives 
The primary objective of this study is to evaluate the safety of SAN021 compared to placebo when 
administered topically for up to 42 days to adults who have a clinical diagnosis of mild-to-
moderate plaque psoriasis. Safety will be assessed by evaluating the number and percentage of 
subjects reporting at least one adverse event (AE) tabulated with respect to severity, duration, and 
relationship to the study drug.  
1.1.2 
Additional Objectives 
Additional objectives are to evaluate tolerability and preliminary efficacy. Tolerability will be 
assessed based on the number of subjects reporting discomfort during or immediately following 
application of study drug in the treatment areas. Discomfort will also be recorded as an AE.  
Preliminary efficacy will be assessed based on the following summaries:  
o Percentage of subjects who have a ≥25% reduction in the Psoriasis Area and 
Severity Index (PASI) score at any point during the 42 days of treatment. 
o Percentage of subjects who have a ≥50% reduction in the PASI score at any point 
during the 42 days of treatment. 
o Percentage of subjects with a PGA score of  “clear” or “almost clear” at any time 
during the 42 days of treatment.  
o Percentage of subjects achieving at least a 1-grade improvement in Physician’s 
Global Assessment (PGA) score.  
o Percentage of subjects achieving a 2-grade improvement in PGA score. 
 
STUDY DESIGN 
2.1 
Overview of Study Design 
This trial will be a double blind, multi-center, randomized, placebo controlled study to evaluate the 
safety, tolerability, and efficacy of SAN021 when administered topically for up to 42 days to adults 
between the ages of 18 to 65 years inclusive who have a clinical diagnosis of mild-to-moderate 
plaque psoriasis. Subjects will enter the Screening Period once the informed consent and 
photographic consent process has been completed. Subjects with mild-to-moderate plaque 
psoriasis, as defined by a PASI score between 2 and 12, that, in the opinion of the investigator, is 
appropriate for topical treatment, covers a minimum of 1.0% and a maximum of 10.0% body 
surface area in the permitted treatment areas, and who meet all of the inclusion and none of the 
exclusion criteria will be enrolled. 
Once subject eligibility is confirmed and the screening procedures completed, all enrolled subjects 
will start the Treatment Period of the study. All enrolled subjects will receive either 10% SAN021 


Santalis Pharmaceuticals 
Protocol No. SAN021-03: Statistical Analysis Plan 
 
FINAL 20DEC2017 
 
    Page 3 
or placebo serum (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. 
Subjects will be instructed on how to apply the study medication twice daily for 42 days. Subjects 
will return to the clinic for study-related assessments on Study Days 7, 14, 28 and a final visit on 
Day 42. On Study Day 49, subjects will receive a follow-up phone call and be queried for 
condition status since going off study. 
Table 2.1: Visit Schedule 
Screening 
Baseline[1] 
 Treatment   
Follow-up 
Call[2] 
Day -7 
to 0 
Day 1 
Day 7 
(±2 days) 
Day 14 
(±2 days) 
Day 28 
(±2 days) 
Day 42 
(±2 days) 
Day 49 
(±2 days) 
 
Visit 1 
Visit 2 
Visit 3 
Visit 5 
Visit 6 
 
[1] Screening and Baseline may occur on the same day provided the informed consent and photography consent 
process has been completed and the consents have been signed. 
[2] Follow-up may be extended if adverse events require time to assess. 
2.2 
Sample Size 
There is no formal assessment of sample size. The sample size of 72 subjects was chosen to ensure 
at least 60 subjects complete the study. The sample size is not expected to yield statistically 
significant results, and there are no inferential statistical analyses.    
 
ANALYSIS POPULATIONS   
3.1 
Safety Analysis Set 
The Safety Analysis Set is defined as all enrolled and randomized subjects who applied at least one 
treatment of the study drug. 
3.2 
Full Analysis Set 
The Full Analysis Set (FAS) is defined as all randomized subjects who applied at least one 
administration of the study drug and who had at least one post-baseline efficacy assessment.  
3.3 
Per Protocol Analysis Set 
The Per Protocol Analysis Set (PP) is defined as all randomized subjects who applied at least one 
administration of the study drug and who had at least one post-baseline efficacy assessment who do 
not have any major protocol violations, including:  
 Violations of inclusion/exclusion criteria. 
 Use of prohibited concomitant medications. 
 Noncompliance (i.e., less than 60% compliant with study treatment), as determined by the 
average product usage for the duration of participation.  
 Failure to provide a clinical observation at Day 42. 
 A scheduled visit occurring more than 5 days outside of the +/- 2-day visit window. 
Although non-compliance is defined in the protocol as <80% compliance with study treatment, 
subsequent consideration of subject medication use evaluated prior to study data unmasking lead to 
a reduction in the threshold to <60% compliance. 


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3.4 
Other Analysis Sets 
An Intent-to-Treat Analysis Set (ITT) is described in the protocol as all subjects enrolled who 
apply at least one treatment of the study drug or placebo. However, there is no analysis specific to 
the ITT population and it will not be used in the generation of any tables or listings.  
The Enrolled Population is defined as all subjects who signed the informed consent. The Enrolled 
Population is equivalent to the ITT and is referred to in the generation of listings and tabulation of 
patient disposition.  
 
STATISTICAL METHODS OF ANALYSIS 
4.1 
Statistical Considerations 
Data listings and summary tables will be provided. Listings will include all data captured on the 
electronic case report form (eCRF) unless specified otherwise. Calculated (derived) variables will 
be listed as appropriate. Summary tables will be provided for select variables as described in 
Section 5 through Section 8. Analyses by visit will be performed on nominal visits regardless of 
actual visit day. The exception will be the case where a subject discontinued prior to Day 42 yet 
data were mistakenly logged in the Day 42 eCRFs, as Day 42 represents end of treatment. Here 
data will be analyzed on the appropriate study visit day according to the visit window in which the 
actual study day falls; this will allow for correct implementation of the last observation carried 
forward method. 
4.1.1 
Quantitative Assessments 
Quantitative assessments (continuous data) will be summarized by reporting the number of subjects 
(n), mean, standard deviation (SD), median, minimum value, and maximum.  
4.1.2 
Qualitative Assessments 
Qualitative assessments (categorical data) will be summarized by reporting the frequency (count 
and percent) of subjects falling within the category. Unless specified otherwise for a particular 
assessment, the denominator for calculating a percentage will be the total number of subjects in the 
analysis population for the subgroup being analyzed; for example, within study arm, the number of  
subjects within the study arm in the analysis population will be the denominator. For overall 
summaries, the total number of subjects in the analysis population will be used as the denominator.  
4.2 
Methods for Handling Missing Data 
Missing efficacy data will be imputed using the last observation carried forward unless specified 
otherwise; unscheduled visit data will be included in the carry forward procedure. No imputations 
will be made for missing safety data.   
 
EVALUATION OF SUBJECT DISPOSITION AND EXPOSURE 
5.1 
Subject Disposition 
All analyses in this section will be performed using the Enrolled Population. Subject disposition in 
terms of all randomized, completed or discontinued status, and reason for discontinuation will be 
summarized for each study arm and over all study arms by count and percent. Analysis populations 
(FAS, PP, and Safety) will be summarized for each study arm and over all study arms by count and 


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percent. All percentages will be based on the Enrolled Population. Details of subject disposition 
and discontinuation status will be provided in a by-subject listing.   
5.2 
Study Product and Visit Compliance  
All analyses in this section will be performed using the Safety Population. Study visit attendance 
will be summarized by study arm for each follow-up visit. The count and percent of subjects who 
attended their visit will be calculated.  
Study product compliance parameters will be summarized using descriptive statistics for each 
study arm. These parameters include the following: 
 Number of applications missed (quantitative assessment) 
 Total weight of product used (quantitative assessment) 
 Average weight per application of product (quantitative assessment) 
 The number and percentage of subjects who received fewer than 60% of prescribed 
applications (and considered non-compliant with the treatment) at each visit, and over all 
follow-up visits.   
Compliance will be based on the baseline body surface area (bsa) of the treated area times 0.25 
(W=bsa x 0.25).  The number of applications per study day is two, and will be assumed to be one 
on each visit day, except baseline, which will be assigned two applications. The number of 
applications (X) for an interval will then be: 
 from baseline to a follow-up visit: X = (current visit date – baseline date) x 2 + 1 
 from a follow-up visit to a subsequent follow-up visit:  
X = (current visit date – previous visit date) x 2; 
and therefore, the expected weight of drug applied (EW) will be calculated as: 
 EW=X (W) 
The actual amount of drug applied in an interval (AW) will be the difference between the bottle 
weights at the relevant visits:  
 AW= weight of bottle at current visit – weight of bottle at previous visit 
The actual compliance will be calculated as the percentage (C) of what was used versus what was 
expected to be used:  
 C= (AW/EW) x 100 
This value may be greater than 100%. However, if the value is less than 60%, then the subject will 
be considered non-compliant for that study treatment interval.  
Using these same calculations, compliance over all follow-up visits will be calculated using 
available data from the medication dispensation log. Weight of drug used from a bottle will be the 
difference of the last medication weight reported and the weight of the bottle at dispensation. If 
multiple bottles are used, cumulative product weight will be calculated. 
 
 EVALUATION OF BASELINE CHARACTERISTICS 
Analyses in this section will be performed using the Safety Analysis Set by study arm and overall 
study arms.  


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6.1 
Demographics 
Demographic data will be summarized for the quantitative (or numerical) assessments (age, height 
(cm), and weight (kg)) and the qualitative (or categorical) assessments (gender, race, and 
ethnicity). If multiple races are reported for a single subject the count will be ascribed to the ‘other’ 
category. Percentages will be based on the number of non-missing responses. Results will be 
presented in by-subject listings. 
6.2 
Baseline Disease Characteristics 
Disease characteristics at baseline will be summarized for quantitative assessments, percent of 
body surface area being treated and PASI, and the qualitative assessments, target treatment area 
and PGA score.  
6.3 
Medical History/Signs and Symptoms 
Medical conditions reported in the medical history will be mapped to preferred term (PT) and 
system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA 19.0). 
Results will be provided in a by-subject listing. 
 
EVALUATION OF SAFETY PARAMETERS 
All safety analyses will be performed using the Safety Analysis Set.  
The safety parameters collected and monitored during this study include adverse events, treatment 
tolerability, and concomitant medications.  
7.1 
Adverse Events 
An AE is any reaction, side effect, or other untoward event, regardless of relationship to study 
drug, that starts any time after the beginning of dosing. Non-serious AEs will be captured through 
the last treatment application, Day 42/exit, and serious AEs will be captured up through 28 days 
following the discontinuation of therapy.  
All AEs reported will be considered to be treatment-emergent. Verbatim adverse events will be 
mapped to PT and SOC using MedDRA 19.0.  
Tabular summaries of treatment-emergent adverse events (TEAEs) in terms of number of subjects 
will be presented by each study arm for the following: 
 PT presented in order of descending incidence in the SAN021 group then 
alphabetically 
 SOC and PT presented in order of descending incidence in SOC, then PT, in the 
SAN021 group, then alphabetically by SOC and PT 
 repeat presentation for subset of study-drug related events 
 SOC, PT, and maximum severity grade (mild, moderate, severe) presented 
alphabetically by SOC and PT 


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Adverse events will be counted as treatment related if they are evaluated as possibly, probably, or 
definitely related to study treatment. Subjects will be counted once within each level of 
summarization within each study arm for the calculation of incidence. 
A summary of count and percent of subjects with at least one event in the following categories will 
be tabulated: any TEAE, any mild TEAE, any moderate TEAE, any severe TEAE, any treatment-
related TEAE, any serious TEAE, any TEAE that led to discontinuation of study drug, and any 
deaths. 
A comprehensive listing of all AEs will be provided by subject, which will include the duration of 
each event. Duration will be calculated as the stop date of the event minus the start date, unless the 
even is determined ongoing at exit. 
7.2 
Treatment Tolerability 
Treatment tolerability will be summarized at each visit by the number of subjects who experienced 
discomfort during or immediately following the study drug application (Yes, Discomfort). 
Tolerability will be summarized over all follow-up visits by the number of subjects who reported 
discomfort at any visit during the study. In these analyses, all percentages will be based on the 
number of responses. Results will be provided in a by-subject listing.  
7.3 
Prior and Concomitant Medication/Therapy 
All prior and concomitant medications will be coded with WHODrug (MAR2016) and results will 
be presented in a by-subject listing with prior or ongoing-at-baseline medication/therapy identified.   
 
EVALUATION OF EFFICACY PARAMETERS 
Analyses in this section will be based on the FAS and the PP analysis set. The primary set for 
efficacy analyses will be the FAS; supportive analyses will be based on the PP. All analyses will be 
performed by study arm with missing data imputed using the last observation carried forward. 
8.1 
Physician’s Global Assessment 
The PGA is a categorical assessment of psoriasis severity made according to the following scale:  
Grade 
Score Description  
Clear 
0 
No signs of psoriasis (post-inflammatory hyperpigmentation may be 
present) 
Almost 
Clear 
1 
Intermediate between mild and clear 
Mild 
2 
Slight scaling plaque elevation, scaling, and/or erythema 
Moderate 
3  
Moderate plaque elevation, scaling, and/or erythema 
Severe 
4 
Very marked plaque elevation, scaling, and/or erythema 
 


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The incidence of clear/almost clear grading (score of 0 or 1) will be summarized by visit. A 
summary over all follow-up visits will also be provided and is defined as the number and 
percentage of subjects achieving clear/almost clear at any time point during the 42 days of therapy.  
Improvement in scores will also be calculated as change from baseline score  
(follow-up – baseline) by follow-up visit and over all follow-up visits; over all follow-up visits will 
be based on the best change from baseline (lowest value) at any time point during the 42 days of 
therapy. Improvement in score from baseline score will be assigned to the category of no 
improvement if either no change or a worsening score (positive change) occurs, or into one or both 
of the categories >=1 grade improvement, and =2 grade improvement (i.e., subjects with a 2 grade 
improvement will also be counted in the >= 1 grade improvement). Count and percent of subjects 
in each category will be provided.  
The frequency distribution of scores by each visit will be provided, and the results will be 
presented in a by-subject listing.  
8.2 
Psoriasis Area and Severity Index 
The PASI is a continuous measure of psoriasis severity with scores that can range from 0 to 72 
with higher scores indicating more severe conditions. For this study the population is required to 
have PASI scores between 2 and 12, inclusive, at baseline. Scores will be summarized by visit with 
n, mean, SD, median, minimum, and maximum. Change from baseline will be calculated (follow-
up value – baseline value) and summarized by follow-up visit. Change values that are negative 
represent an improvement. Percent change from baseline ((follow-up value – baseline 
value)/baseline value) x 100 will also be summarized by follow-up visit.  
Percent change from baseline will be assigned to one or more of the following categories: 
Group  Percent Reduction Category
Percent change from baseline values
1 
< 25% Reduction 
> -25.0 
2 
≥ 25% Reduction 
≤ -25.0 
3 
≥ 50% Reduction 
≤ -50.0 
4 
≥ 75% Reduction 
≤ -75.0 
 
These groups are not mutually exclusive; results that fall into group 4 will also be counted in 
groups 2 and 3, likewise results that fall into group 3 but not group 4 will also be counted in group 
2. The frequency distribution of subjects within each of these groups will be summarized by visit. 
A summary over all follow-up visits will include the number and percent of subjects achieving 
their best (lowest value/greatest reduction) percent change at any time point during the 42 days of 
therapy.  
The results will be presented in a by-subject listing. 
 


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8.3 
Body Surface Area 
Body surface area is a continuous measure of psoriasis extent. For this study the population 
inclusion criteria specified a body surface area between 1.0% and 10.0% inclusive. Values will be 
summarized by visit with n, mean, SD, median, minimum, and maximum. Change from baseline 
will be calculated (follow-up value – baseline value) and summarized by follow-up visit. Here, 
change values that are negative represent an improvement. Percent change from baseline ((follow-
up value – baseline value)/baseline value) x 100 will also be summarized by follow-up visit.  
The results will be presented in a by-subject listing. 
8.4 
Post Study Status 
Data will be presented in a by-subject listing. 
 
CONVENTIONS FOR CALCULATIONS AND TABULATIONS 
Table 9.0 Conventions for Calculations and Tabulations 
CONVENTION 
DESCRIPTION 
Age calculation 
Age is calculated as an integer in years as the difference 
between the subject’s date of informed consent and the date of 
birth. Specifically, if a subject’s birthday has been reached by 
the informed consent date then age will be the difference in 
years, otherwise age will be the difference in years minus 1.  
Baseline 
Baseline is defined as assessments completed on Visit 1 (Day 1) 
prior to the administration of the study drug unless otherwise 
specified.  
Study Day  
Date of visit or evaluation – baseline date + 1 
Percentage calculation 
Percentages are calculated as 100*numerator/denominator. 
Rounding is not necessary because rounding is handled by the 
display format. Denominator is the total number of subjects in a 
column group unless otherwise specified.  
AE counting: treatment 
emergence 
An AE will be considered treatment emergent if it begins on or 
after the time of the first study treatment application. If the start 
date is the same as the date of first application (Day 1), the times 
are not present, or there is no indication that the AE began 
before dosing, the event will be considered treatment emergent.  
AE counting: general 
summary 
In summary displays, AEs are counted only once per subject 
within a category (e.g., over all and preferred term).  
AE counting: summary by 
assessment 
When AEs are summarized within levels of another AE 
assessment (e.g., causality or severity), AEs are counted once 
per subject at the worst level of the assessment (e.g., least 


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CONVENTION 
DESCRIPTION 
complementary relationship or greatest severity). A missing or 
unknown value for the assessment will be considered worst.  
Change from Baseline 
current visit value – baseline visit value 
Percent Change from 
Baseline 
((current visit value —baseline visit value) / baseline visit value) 
x 100 
 
 SPECIFICATIONS FOR ANALYSIS DISPLAYS 
All headers, titles, footnotes, and footers specified in the table and listing shells will be displayed in 
the produced output. Notes to the programmer will not be included in the produced output. Any 
minor deviation will not necessitate a revision to the Statistical Analysis Plan (SAP) nor will it be 
considered a deviation from planned analyses. Only major differences in the analysis methods or 
data handling will necessitate such documentation. The shells of tables and listings will be 
provided in a separate document from this SAP. 
10.1 Format 
All analysis displays (with the exception of figures) will be created by using statistical and 
summarization procedures in SAS®, Version 9.4 or later, using a line size of 132 and a page size of 
50. All margins of all tables and listing will be a minimum of 0.8 inch. 
All displays are intended to be printed in landscape layout unless otherwise specified.  
At the top of each table/listing/figure, a number followed by the title will be presented. After the 
title line, a sub-title or population information may be presented. Horizontal lines will appear 
before and after the column heading of the table/listing. Footnotes will be under the main body of 
the table or listing display.  
The sponsor name, protocol number, status of the output (i.e., draft or final), SAS program name, 
and the date and time of creation will be on the output. The page number will appear on the upper 
right corner of each output (Page X of Y).  
10.1.1 Conventions for Tables 
Tables will be delivered to the sponsor in Microsoft Word, Times New Roman, 10 point font. If 
necessary for formatting, an alternate font type or size may be used. The conventions for the 
analysis displays are shown in Table 10.1.1.  
Table 10.1.1 Conventions for Tables 
CONVENTION 
DESCRIPTION 
Decimals for summary 
statistics 
General Rule: Relative to the number of decimals in the original 
data, 1 more decimal for the mean, median, and percentiles, 2 
more decimals for standard deviation (SD) will be displayed, 


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and the same number for minimum, maximum, and/or range. 
The maximum number of decimals will be 4. Some lab 
parameters or other data may require judicious deviation from 
this rule. Wherever possible, data will be decimal aligned.  
Decimals and format for 
percentages 
Unless otherwise specified, frequency tabulations will be 
presented by number and percentage, with the percentage in 
parentheses following the number. Percentages will be displayed 
to 1 decimal. A count of zero will exclude any percentage 
display. The ‘%’ will not follow the percentage value if ‘n(%)’ 
is displayed in the column header. 
 
10.1.2 Conventions for Listings 
Listings will include all data recorded on the eCRFs. Listings may include derived variables that 
are reflected in analyses, where specified in Section 5 through Section 8 (e.g., change from 
baseline values, study day).  
Listings will be delivered to the sponsor in Microsoft Word, Courier New, 8 point font. If 
necessary for formatting, an alternate font type or size may be used. The conventions for the 
listings are shown in Table 10.1.2, and apply for each listing where relevant. 
Table 10.1.2 Conventions for Listings 
CONVENTION 
DESCRIPTION 
Population 
All enrolled subjects will be included unless otherwise specified.
Subject number 
Subject numbers will be displayed as site number – subject 
number (XX-XXX).  
Dates 
Date information in the listing will use the date9. format (i.e., 
01JAN2011) where possible. Otherwise, date formats will be 
displayed as recorded on the eCRF. 
Unknown 
‘U’ will represent ‘Unknown’ in date variables and categorical 
variables unless otherwise specified on the eCRF. 
Missing Values 
Missing values will be listed as represented in the clinical 
database (e.g., blanks, ‘NR’ for not reported). 
Variable Units 
In the listings, a unit associated with a variable will be presented 
within parentheses in the column label.  
Visit Description 
A visit column will be provided with the Visit ID (or label) and 
an adjacent column with the corresponding date of evaluation, if 
available. 


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CONVENTION 
DESCRIPTION 
Sort order 
All listings will be sorted by SAN021 first, followed by Placebo, 
the subject number portion of the subject ID (site # - subject #), 
followed by the collection date, or visit date if the collection 
date is unavailable, or AE start state followed by AE stop date 
for Adverse Events. 
 
10.2 Summary Tables to be Provided 
Tables that will be generated for both the FAS and PP analysis sets will be identified by the last 
decimal value of the table number ‘.1’ and ‘.2’ respectively, and appear as ‘.X’ in the table shells. 
Table 10.2 Summary Tables 
Table 
Number 
Title 
Analysis 
Population 
14.1.1 
Subject Disposition and Exit Status 
Enrolled 
Population 
14.1.2 
Demographics and Baseline Characteristics 
Safety Population 
14.1.3 
Baseline Disease Characteristics  
Safety Population 
14.2.1.1 
Study Visit Compliance  
Safety Population 
14.2.1.2 
Study Product Compliance  
Safety Population 
14.2.2.1.X 
Physician’s Global Assessment – Incidence of Clear/Almost 
Clear During the Study 
Full Analysis Set, 
Per Protocol 
14.2.2.2.X 
Physician’s Global Assessment - Improvement by Visit  
Full Analysis Set,  
Per Protocol 
14.2.2.3.X 
Physician’s Global Assessment - Scores by Visit  
Full Analysis Set, 
Per Protocol 
14.2.3.1.X 
Psoriasis Area and Severity Index – Categories of Percent 
Reduction 
Full Analysis Set, 
Per Protocol 
14.2.3.2.X 
Psoriasis Area and Severity Index – Score by Visit 
Full Analysis Set, 
Per Protocol 
14.2.3.3.X 
Psoriasis Area and Severity Index –Change from Baseline 
Full Analysis Set, 
Per Protocol 
14.2.3.4.X 
Psoriasis Area and Severity Index –Percent Change from 
Baseline  
Full Analysis Set, 
Per Protocol 
14.2.4.1.X 
Body Surface Area – Score by Visit  
Full Analysis Set, 
Per Protocol 
14.2.4.2.X 
Body Surface Area – Change from Baseline  
Full Analysis Set, 
Per Protocol 
14.2.4.3.X 
Body Surface Area – Percent Change from Baseline 
Full Analysis Set 
/Per Protocol 
14.3.1.1 
Summary of Treatment-Emergent Adverse Events  
Safety Population 


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Table 
Number 
Title 
Analysis 
Population 
14.3.1.2 
Incidence of Treatment-Emergent Adverse Events by Preferred 
Term  
Safety Population 
14.3.1.3 
Incidence of Treatment-Emergent Adverse Events by Preferred 
Term within System Organ Class  
Safety Population 
14.3.1.4 
Incidence of Treatment-Emergent Adverse Events  Related to 
Treatment by Preferred Term within System Organ Class 
Safety Population 
14.3.1.5 
Incidence of Treatment-Emergent Adverse Events by 
Maximum Severity and Preferred Term within System Organ 
Class 
Safety Population 
14.3.2.1 
Tolerability by Visit  
Safety Population 
 
10.3 Listings to be Provided 
Listings are numbered considering the ICH guidance, and are based on the Enrolled Population 
unless noted otherwise in Table 10.3. 
Table 10.3 Listings 
Listing 
Number 
Title 
Analysis Population 
 16.2.1.1 
Study Completion/Termination 
Enrolled Population 
 16.2.1.2 
Evaluability 
Enrolled Population 
 16.2.2.1 
Demographics and Eligibility 
Enrolled Population 
 16.2.2.2 
Inclusion/Exclusion Criteria 
Enrolled Population 
 16.2.3 
Alcohol, Cigarette, and Illegal Drug/Substance Use 
Enrolled Population 
 16.2.4 
Medical History 
Enrolled Population 
 16.2.5 
Pregnancy Test 
Enrolled Population 
 16.2.6.1 
Treatment Medication Dispensation 
Enrolled Population 
 16.2.6.2 
Treatment Application, Compliance, and Tolerability 
Assessment 
Enrolled Population 
 16.2.6.3 
Target Treatment Area and Body Surface Area 
Enrolled Population 
 16.2.6.4 
Physician’s Global Assessment and Psoriasis Area and 
Severity Index 
Enrolled Population 
 16.2.6.5 
Photography of Treatment Areas 
Enrolled Population 
 16.2.7 
Adverse Events 
Enrolled Population 
 16.2.8 
Prior and Concomitant Medication or Therapy  
Enrolled Population 
 16.2.9 
Physical Exam 
Enrolled Population 
 16.2.10 
Telephone Contact 
Enrolled Population 
 16.2.11 
Visit Dates and Subject Status 
Enrolled Population