Clinical trial NCT02871479
Conditions: Atopic Dermatitis Eczema
Keywords: Atopic Dermatitis Eczema
Sponsor: Santalis Pharmaceuticals, Inc.
Start date: 2017-04-21; Completion date: 2018-08-31
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients at least 18 years of age, with atopic dermatitis.

Detailed description:
Subjects will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Subjects with a total body surface area (BSA) of ≥2% and ≤ 15% atopic dermatitis involvement, in the treatable 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, the subject will start the Treatment Period of the study. All enrolled subjects will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) OR 10% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at Visit 1 Baseline. Subjects will be instructed on how to apply the study medication twice daily for 28 days. Subjects will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Subjects will receive a telephone contact from the site, on Study Days 21 and 35.

Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

In addition, cutaneous tolerability will be evaluated at each visit. Tolerability evaluation will be based on subjects reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are not to be included in this evaluation.

Efficacy will be assessed at each study visit through the completion of the IGA, EASI and BSA calculation.

During the active treatment period, subjects will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).

Arms: arm 1: A cream containing 5% East Indian sandalwood oil (EISO). arm 2: The vehicle cream arm 3: A cream containing 10% East Indian Sandalwood Oil (EISO).
Interventions: intervention 1: SAN007 5% cream intervention 2: Placebo intervention 3: SAN007 10% cream
Intervention descriptions: intervention 1: 5% EISO in a cream formulation applied twice a day for up to 28 days. intervention 2: A placebo cream containing the same components as the vehicle for the active intervention arm intervention 3: 10% EISO in a cream formulation applied twice a day for up to 28 days.

Protocol documents:
Prot_001.pdf: 















































































































SAP_000.pdf: 
Santalis Pharmaceuticals 
Protocol No. SAN007-02: Statistical Analysis Plan Implementation Document 
 
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
IMPLEMENTATION DOCUMENT (SAPID) 
 
Santalis Pharmaceuticals 
 
Protocol: SAN007-02 
 
A Double-Blind, Randomized, Placebo-Controlled, Safety, 
Tolerability, and Efficacy Trial of a Novel Botanical Drug Product, 
Containing East Indian Sandalwood Oil (EISO) For the Treatment of 
Atopic Dermatitis 
 
Authors:                                       Richard Cambron, Julie Mordaunt 
 
Document status:                        FINAL 
Version dates:                            11OCT2018


Santalis Pharmaceuticals 
Protocol No. SAN007-02: Statistical Analysis Plan Implementation Document 
 
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TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..................................................................................................... iii 
 
STUDY INTRODUCTION ................................................................................................. 1 
1.0
1.1 
Study Objectives ........................................................................................................... 1 
1.1.1 
Primary Objectives .................................................................................................. 1 
1.1.2 
Additional Objectives .............................................................................................. 1 
 
STUDY DESIGN .................................................................................................................. 1 
2.0
2.1 
Overview of Study Design ........................................................................................... 1 
2.2 
Sample Size .................................................................................................................. 2 
 
ANALYSIS POPULATIONS ............................................................................................. 2 
3.0
3.1 
Safety Analysis Set ....................................................................................................... 2 
3.2 
Full Analysis Set .......................................................................................................... 2 
3.3 
Per Protocol Analysis Set ............................................................................................. 2 
3.4 
Other Analysis Sets ...................................................................................................... 3 
3.5 
Treatment Assignment ................................................................................................. 3 
 
STATISTICAL METHODS OF ANALYSIS ................................................................... 3 
4.0
4.1 
Statistical Considerations ............................................................................................. 3 
4.1.1 
Quantitative Assessments ........................................................................................ 3 
4.1.2 
Qualitative Assessments .......................................................................................... 3 
4.2 
Methods for Handling Missing Data ............................................................................ 3 
 
EVALUATION OF SUBJECT DISPOSITION AND EXPOSURE ............................... 4 
5.0
5.1 
Subject Disposition ....................................................................................................... 4 
5.2 
Study Product and Visit Compliance ........................................................................... 4 
 
EVALUATION OF BASELINE CHARACTERISTICS ................................................. 4 
6.0
6.1 
Demographics ............................................................................................................... 5 
6.2 
Baseline Disease Characteristics .................................................................................. 5 
6.3 
Medical History/Signs and Symptoms ......................................................................... 5 
 
EVALUATION OF SAFETY PARAMETERS ................................................................ 5 
7.0
7.1 
Adverse Events ............................................................................................................. 5 
7.2 
Treatment Tolerability .................................................................................................. 6 


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7.3 
Prior and Concomitant Medication/Therapy ................................................................ 6 
 
EVALUATION OF EFFICACY PARAMETERS ........................................................... 6 
8.0
8.1 
Investigator’s Global Assessment ................................................................................ 6 
8.2 
Eczema Area Severity Index ........................................................................................ 7 
8.3 
Body Surface Area ....................................................................................................... 8 
8.4 
Post Study Status .......................................................................................................... 8 
 
CONVENTIONS FOR CALCULATIONS AND TABULATIONS ............................... 8 
9.0
 SPECIFICATIONS FOR ANALYSIS DISPLAYS .......................................................... 9 
10.0
10.1 Format .......................................................................................................................... 9 
10.1.1 
Conventions for Tables ........................................................................................... 10 
10.1.2 
Conventions for Listings ......................................................................................... 10 
10.2 Summary Tables to be Provided .................................................................................. 11 
10.3 Listings to be Provided ................................................................................................. 13 
 APPENDIX A.     Shell Tables and Listings ...................................................................... 14 
11.0
 


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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
BSA 
Body Surface Area 
cm 
Centimeter 
EASI 
Eczema Area and Severity Index 
eCRF 
Electronic Case Report Form 
EISO 
East Indian Sandalwood Oil 
FAS 
Full Analysis Set 
g 
Gram 
IGA 
Investigator’s Global Assessment 
ITT 
Intent-to-Treat 
kg 
Kilogram 
MedDRA 
Medical Dictionary for Regulatory Activities 
N 
population size (N for sample size, n for available data) 
PP 
Per Protocol 
PT 
Preferred Term 
SAPID 
Statistical Analysis Plan Implementation Document 
SAS 
Statistical Analysis System 
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). 


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1 
 
 
STUDY INTRODUCTION 
1.0
This statistical analysis plan is based on the protocol “A Double-Blind, Randomized, Placebo-
Controlled, Safety, Tolerability, and Efficacy Trial of a Novel Botanical Drug Product, Containing 
East Indian Sandalwood Oil (EISO) For the Treatment of Atopic Dermatitis”, Amendment No. 6, 
dated 18 September 2017.  
1.1 
Study Objectives 
1.1.1 
Primary Objectives 
The primary objective of this study is to evaluate the safety of SAN007 when administered to 
subjects with mild to moderate atopic dermatitis. 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:  
• Percentage of subjects who have a ≥25% reduction in the Eczema Area and Severity Index 
(EASI) at any point during the trial. 
• Number of subjects with an Investigator’s Global Assessment (IGA) score of “clear” or 
“almost clear” at any time during the 28 days of treatment.  
• Percentage of subjects who have a ≥50% reduction in the EASI at any point during the trial. 
• Percentage of subjects achieving at least a 1-grade improvement in IGA score.  
• Percentage of subjects who have at least a 20% reduction in BSA affected by atopic 
dermatitis. 
 
STUDY DESIGN 
2.0
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 preliminary efficacy of SAN007 when administered topically for up to 28 
days to adults at least 18 years of age with atopic dermatitis. Subjects will enter the Screening 
Period once the informed consent and photographic consent process has been completed. Subjects 
with a total body surface area (BSA) of ≥2% and ≤ 15% atopic dermatitis involvement in the 
treatable areas, and who meet all of the inclusion, and none of the exclusion criteria, will be 
enrolled. 
The original protocol design is based on randomization of enrolled subjects to either 5% SAN007 
cream or placebo cream in a 2:1 ratio. Amendment 6 of the study protocol added the randomization 
of 10% SAN007 cream or placebo cream in a 2:1 ratio. This new randomization is implemented at 
new sites and sites continuing enrollment once the 5%/Placebo randomization had been completed 
at the site. This will result in some sites with only the 5%/Placebo groups, some sites with only the 


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10%/Placebo groups, and some sites with both 5%/Placebo and 10%/Placebo groups. 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% SAN007 cream, 5% 
SAN007 cream or placebo cream as described above with the first dose applied at Visit 1 Baseline. 
Subjects will be instructed on how to apply the study medication twice daily, ≥ 8 hours between 
applications, for 28 days. Subjects will return to the clinic for study-related assessments on Study 
Days 7, 14, and 28 for study-related assessments. On Study Days 21 and 35, subjects will receive a 
follow-up phone call. 
Table 2.1: Visit Schedule 
Screening 
Baseline[1] 
←⎯⎯⎯⎯ Treatment ⎯⎯⎯→  
Follow-up 
Day -7 
to 0 
Day 1 
Day 7 
(±2 days) 
Day 14 
(±2 days) 
Day 21  
(±2 days) 
Day 28 
(±2 days) 
Day 35 
(±2 days) 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Call 
Visit 5 
Call 
[1] Screening and Baseline may occur on the same day. 
2.2 
Sample Size 
There is no formal assessment of sample size. The sample size of 100 subjects was chosen to 
ensure at least 90 subjects complete the study. The sample size is not expected to yield statistically 
significant results.    
 
ANALYSIS POPULATIONS   
3.0
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 and 
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 28; 
• A scheduled visit occurring more than 5 days outside of the +/- 2-day visit window. 


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Although non-compliance is defined in the protocol as <90% 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. 
3.4 
Other Analysis Sets 
An Intent-to-Treat Analysis Set (ITT) is defined as all subjects enrolled and randomized into the 
study. 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 referred to in the generation of listings and tabulation of subject disposition.  
3.5 
Treatment Assignment 
For all analysis sets described above, subjects will be analyzed as treated. Mis-randomizations that 
resulted in subjects receiving an incorrect treatment will not be reassigned. These subjects will be 
noted in the clinical study report. 
 
STATISTICAL METHODS OF ANALYSIS 
4.0
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.  Early termination visits will be assigned to a visit if they fall into a visit window, 
otherwise, their data will still be included in the carry forward algorithm. Unscheduled visit data 
will be included in the carry forward algorithm. 
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 value.  
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.   


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EVALUATION OF SUBJECT DISPOSITION AND EXPOSURE 
5.0
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 
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 study visit. The count and percent of subjects who 
attended each 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 
study visits.   
For the assessment of compliance to product use the number of missed applications will be 
summarized instead of the number of received applications (specified in the protocol). The number 
of missed applications is collected at each visit whereas the number of applications received would 
be calculated by number of days on study times two minus the missed applications.  
Compliance will also be based on information collected in the Treatment Medication Dispensation 
page. For any period, compliance (%) will be calculated as 100 x (weight of tube that was 
dispensed – weight of tube returned)/(number of days in this period x 2 x DOSE). DOSE will be 
calculated as initial weight of tube – weight of tube after first on site application (Day 1) since this 
is the dose application demonstrated to the subject.  This value may be greater than 100%. 
However, if the value is less than 60%, the subject will be considered non-compliant for that study 
treatment interval. 
Using these same calculations, compliance over all study visits will be calculated using available 
data from the medication dispensation log. Weight of drug used from a tube will be the difference 
of the last medication weight reported and the weight of the tube at dispensation. If multiple tubes 
are used, cumulative product weight will be calculated. 
 
 EVALUATION OF BASELINE CHARACTERISTICS 
6.0
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 or if races are listed besides the ones 
being summarized 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 EASI, and the qualitative assessments, target treatment area 
and IGA score.  
6.3 
Medical History/Signs and Symptoms 
Medical conditions reported in the pertinent 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 
7.0
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 adverse event (AE) means any untoward medical occurrence associated with the use of a drug 
in humans, whether or not considered drug related. An AE (also referred to as an adverse 
experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of the drug, without judgment about 
causality. An adverse event can arise from any use of the drug (e.g., off-label use, use in 
combination with another drug) and from any route of administration, formulation, or dose, 
including an overdose. Non-serious AEs will be captured through the last treatment application, 
Day 28/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 SAN007 group then 
alphabetically 
• SOC and PT presented in order of descending incidence in SOC, then PT, in the 
SAN007 group, then alphabetically by SOC and PT 
§ repeat presentation for subset of study-drug related events 


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• SOC, PT, and maximum severity grade (mild, moderate, severe) presented 
alphabetically by SOC and PT 
Adverse events will be counted as treatment related if they are evaluated as possibly, probably, or 
definitely related to study treatment. Missing relationship will be treated as related. 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. Note that any AE is only considered for its maximum severity. However a subject can have 
more than one AE and each may have a different maximum severity. Thus severity levels are not 
mutually exclusive.  
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 
event 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. Tolerability will be 
summarized over all study 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 
8.0
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. 
Throughout this section the term ‘follow-up visit’ will refer to any post-baseline visit, whether an 
office visit or a telephone contact. Only safety data and status of atopic dermatitis were to be 
collected at the Day 35 follow-up visit.  
8.1 
Investigator’s Global Assessment 
The IGA is a categorical assessment of the treated area made according to the following scale:  
 


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Grade 
Score 
Description  
Clear 
0 
No inflammatory signs of AD 
Almost Clear 
1 
Just perceptible erythema and just perceptible 
population/infiltration 
Mild 
2 
Mild erythema and mild population/infiltration 
Moderate 
3  
Moderate erythema and moderate population/infiltration 
Severe 
4 
Severe erythema and severe population/infiltration 
 
The incidence of clear/almost clear grading (score of 0 or 1) will be summarized by follow-up 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 28 days of therapy.  
Improvement in scores will also be calculated as change from baseline score  
(follow-up value – baseline value) 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 
28 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 the 
category(ies) ≥1 grade improvement, ≥2 grade improvement. Count and percent of subjects 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 
Eczema Area Severity Index  
The EASI is a continuous measure of eczema 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 
EASI scores between 2 and 50, inclusive, at baseline. Scores will be summarized by visit with n, 
mean, SD, median, minimum, and maximum. Change from baseline will be calculated at each 
follow-up visit (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: 


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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 study visits will include the number and percent of subjects achieving their 
best (lowest value/greatest reduction) percent change at any time point during the 28 days of 
therapy.  
The results will be presented in a by-subject listing. 
8.3 
Body Surface Area 
Body surface area is a continuous measure of the percent of atopic dermatitis involvement in the 
permitted treatment areas. For this study the population inclusion criteria specified a body surface 
area between 2.0% and 15.0% 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 ((study visit value – baseline value)/baseline value) 
x 100 will also be summarized by follow-up visit. Finally a table will be generated showing percent 
of subjects achieving at least a 20% reduction in BSA affected by Atopic Dermatitis. 
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 
9.0
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 


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CONVENTION 
DESCRIPTION 
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 
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 
10.0
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 Implementation 
Document (SAPID) 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 are provided in Appendix A. 
10.1 Format 
All analysis displays 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.  


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At the top of each table/listing, 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, 
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 


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Protocol No. SAN007-02: Statistical Analysis Plan Implementation Document 
 
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CONVENTION 
DESCRIPTION 
Population 
All enrolled subjects will be included unless otherwise specified. 
Subject ID 
Subject ID 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. 
Sort order 
All listings will be sorted by 10% SAN007 first, followed by 5% 
SAN007, then Placebo, subject ID, 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 
Table 10.2 Summary Tables 
Table 
Number 
Title 
Analysis 
Population 
14.1.1 
Subject Disposition and Exit Status 
Enrolled  
14.1.2 
Demographics and Baseline Characteristics 
Safety  
14.1.3 
Baseline Disease Characteristics  
Safety  
14.2.1.1.1 
Study Visit Compliance  
Full Analysis Set  
14.2.1.1.2 
Study Visit Compliance  
Per Protocol  
14.2.1.2.1 
Study Product Compliance  
Full Analysis Set  
14.2.1.2.2 
Study Product Compliance  
Per Protocol  
14.2.2.1.1 
Investigator’s Global Assessment (IGA) – Incidence of 
Clear/Almost Clear During the Study 
Full Analysis Set  
14.2.2.1.2 
Investigator’s Global Assessment (IGA) – Incidence of 
Clear/Almost Clear During the Study 
Per Protocol  


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Protocol No. SAN007-02: Statistical Analysis Plan Implementation Document 
 
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Table 
Number 
Title 
Analysis 
Population 
14.2.2.2.1 
Investigator’s Global Assessment (IGA) – Improvement by Visit 
Full Analysis Set  
14.2.2.2.2 
Investigator’s Global Assessment (IGA) – Improvement by Visit 
Per Protocol  
14.2.2.3.1 
Investigator’s Global Assessment (IGA) – Scores  by Visit 
Full Analysis Set  
14.2.2.3.2 
Investigator’s Global Assessment (IGA) – Scores  by Visit 
Per Protocol  
14.2.3.1.1 
Eczema Area and Severity Index (EASI) – Categories of Percent 
Reduction 
Full Analysis Set  
14.2.3.1.2 
Eczema Area and Severity Index (EASI) – Categories of Percent 
Reduction 
Per Protocol  
14.2.3.2.1 
Eczema Area and Severity Index (EASI) – Scores by Visit 
Full Analysis Set  
14.2.3.2.2 
Eczema Area and Severity Index (EASI) – Scores by Visit 
Per Protocol  
14.2.3.3.1 
Eczema Area and Severity Index (EASI) – Change from Baseline 
by Visit 
Full Analysis Set  
14.2.3.3.2 
Eczema Area and Severity Index (EASI) – Change from Baseline 
by Visit 
Per Protocol  
14.2.3.4.1 
Eczema Area and Severity Index (EASI) – Percent Change from 
Baseline by Visit 
Full Analysis Set  
14.2.3.4.2 
Eczema Area and Severity Index (EASI) – Percent Change from 
Baseline by Visit 
Per Protocol  
14.2.4.1.1 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Percentage Involvement by Visit 
Full Analysis Set  
14.2.4.1.2 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Percentage Involvement by Visit 
Per Protocol  
14.2.4.2.1 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Change from Baseline in Percentage Involvement by Visit 
Full Analysis Set  
14.2.4.2.2 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Change from Baseline in Percentage Involvement by Visit 
Per Protocol  
14.2.4.3.1 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Percent Change from Baseline in Percentage Involvement by 
Visit 
Full Analysis Set  
14.2.4.3.2 
Body Surface Area (BSA) Affected by Atopic Dermatitis – 
Percent Change from Baseline in Percentage Involvement by 
Visit 
Per Protocol  
14.2.4.4.1 
Body Surface Area (BSA) – Subjects Achieving at Least a 20% 
Reduction in BSA Affected by Atopic Dermatitis During the 
Study 
Full Analysis Set  
14.2.4.4.2 
Body Surface Area (BSA) – Subjects Achieving at Least a 20% 
Reduction in BSA Affected by Atopic Dermatitis During the 
Study 
Per Protocol  
14.3.1.1 
Summary of Treatment-Emergent Adverse Events  
Safety  
14.3.1.2 
Incidence of Treatment-Emergent Adverse Events by Preferred 
Term  
Safety  
14.3.1.3 
Incidence of Treatment-Emergent Adverse Events by Preferred 
Safety  


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Table 
Number 
Title 
Analysis 
Population 
Term within System Organ Class  
14.3.1.4 
Incidence of Treatment-Emergent Adverse Events  Related to 
Treatment by Preferred Term within System Organ Class 
Safety  
14.3.1.5 
Incidence of Treatment-Emergent Adverse Events by Maximum 
Severity and Preferred Term within System Organ Class 
Safety  
14.3.2.1 
Tolerability by Visit  
Safety  
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  
16.2.1.2 
Evaluability 
Enrolled  
16.2.2 
Demographics and Eligibility 
Enrolled  
16.2.2a 
Inclusion/Exclusion Criteria 
Enrolled  
16.2.3 
Alcohol, Cigarette, and Illegal Drug/Substance Use 
Enrolled  
16.2.4 
Pertinent Medical History 
Enrolled  
16.2.5 
Pregnancy Test 
Enrolled  
16.2.6.1 
Treatment Medication Dispensation 
Enrolled  
16.2.6.2 
Treatment Application, Compliance, and Tolerability Assessment 
Enrolled  
16.2.6.3 
Target Treatment Area and Body Surface Area 
Enrolled  
16.2.6.4 
Investigator Global Assessment  
Enrolled  
16.2.6.5 
Eczema 
Enrolled  
16.2.6.6 
Photography of Treatment Areas 
Enrolled  
16.2.7 
Adverse Events 
Enrolled  
16.2.8 
Prior and Concomitant Medication or Therapy  
Enrolled  
16.2.9 
Complete Physical Exam 
Enrolled  
16.2.10 
Telephone Contact 
Enrolled  
16.2.11 
Visit Dates and Subject Status 
Enrolled  
 


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Protocol No. SAN007-02: Statistical Analysis Plan Implementation Document 
 
FINAL 11OCT2018 
 
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 APPENDIX A.     SHELL TABLES AND LISTINGS
11.0