Conditions: Epidermolysis Bullosa Epidermolysis Bullosa Simplex
Keywords: Epidermolysis Bullosa (EB) Epidermolysis Bullosa Simplex (EBS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.

Detailed description:
This is an international, multicenter, open-label, long term extension study evaluating the safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Visit 1, EBS subjects who completed the CCP-020-301 double-blind safety and efficacy study or participated in the CCP-020-101 PK study (feeder studies) who meet all the inclusion/exclusion criteria will be eligible to complete 2 treatment cycles of CCP-020.

Each treatment cycle will consist of 8 weeks on treatment (once-daily, at home study medication applications) followed by 8 weeks off treatment (only Investigator approved bland, non-medicated emollient/moisturizer, routine cleansing products and sunscreens) with a maximum of 2 treatment cycles allowed for up to 52 weeks.

At Baseline Visit (corresponding to the final study visit of the feeder study), the investigator will perform a clinical assessment and determine if any of the subject's lesions require treatment (up to 30% BSA). If the subject has active lesions as determined by the Investigator's clinical assessment, the subject will initiate a cycle of once-daily, at home study medication application to their EBS lesions for 8 weeks (treatment period) followed by an 8-week period where no treatment will be administered. Subjects presenting with no active lesions (as determined by the Investigator's clinical assessment) will not begin treatment and instead, will be instructed to return to the clinic for re-evaluation in 8 weeks or upon worsening of EBS lesions, whichever happens first.

Arms:
arm 1: Subjects with active lesions as determined Investigator's clinical assessment, will initiate a cycle of applying diacerein 1% ointment once-daily, study medication, at home to their EBS lesions for 8 weeks.

Following the Treatment Period, subjects will go Off Treatment for 8 weeks using only investigator approved bland, non-medicated emollient/moisturizer, routine cleansing products and sunscreens. As determined Investigator's clinical assessment, subjects may enter into another Treatment Period of 8 weeks.

The duration of a subject's participation in the extension study may be as short as 32 weeks or as long as 52 weeks depending on the cycle initiation schedule for each individual subject.

Interventions: intervention 1: diacerein 1% ointment
Intervention descriptions: intervention 1: Topically apply study medication to lesions identified by the Investigator that require.

treatment

Protocol document:
Prot_000.pdf: 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020
NCT03389308


Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Clinical Study Report CCP-020-302
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Clinical Study Report CCP-020-302
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


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Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN 
An International, Multicenter, Open-label, Long Term Extension 
Study Evaluating the Safety of Diacerein 1% Ointment Topical 
Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) 
Investigational Product: Diacerein 1% Ointment 
Protocol Number: CCP-020-302 
Sponsor: 
Castle Creek Pharmaceuticals, LLC 
233 Mt. Airy Road, 1st Floor 
Basking Ridge, New Jersey 07920 
United States of America 
Version Number: 1.0 
Date: 17 December 2019 
CONFIDENTIAL 
This document is confidential and is a privileged correspondence of Castle Creek Pharmaceuticals, LLC. 
Accepting this document constitutes an agreement by the recipient that no unpublished information herein 
contained will be used, disclosed or published without Castle Creek Pharmaceuticals’ prior written 
approval. 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020
NCT03389308


Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 3 
Version Date:  17 December 2019 
VERSION HISTORY 
 
Version  
Date 
Description 
1.0 
17 Dec 2019 
Original signed version 
 
 
 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 4 
Version Date:  17 December 2019 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................5 
1. 
INTRODUCTION ........................................................................................................6 
2. 
OVERVIEW .................................................................................................................6 
2.1. 
Objectives .....................................................................................................................6 
2.2. 
Trial Design ..................................................................................................................6 
3. 
STUDY ENDPOINTS ..................................................................................................8 
3.1. 
Safety Endpoints ...........................................................................................................8 
3.1.1. 
Adverse Events .............................................................................................................8 
3.1.2. 
Safety Laboratory Evaluations .....................................................................................8 
3.1.3. 
Vital Signs ....................................................................................................................9 
3.1.4. 
Electrocardiogram (ECG) Monitoring ........................................................................10 
4. 
ANALYSIS POPULATIONS ....................................................................................11 
4.1. 
Safety Population ........................................................................................................11 
5. 
GENERAL CONSIDERATIONS FOR DATA ANALYSIS ....................................11 
5.1.1. 
Summary Statistics .....................................................................................................11 
5.1.2. 
Evaluation of Center Effect ........................................................................................11 
5.1.3. 
Assessment Windows and Analysis Day ....................................................................11 
5.1.4. 
Assessments Corresponding to Cycle 1 End and Cycle 2 Start ..................................11 
5.1.5. 
Baseline Definition .....................................................................................................12 
5.1.6. 
Missing Data ...............................................................................................................12 
5.1.6.1. 
Date Values .................................................................................................................12 
5.1.6.2. 
Non-Date Values ........................................................................................................12 
6. 
SUBJECT DATA AND STUDY CONDUCT ...........................................................13 
6.1.1. 
Subject Disposition .....................................................................................................13 
6.1.2. 
Protocol Deviations ....................................................................................................13 
6.1.3. 
Demographic Characteristics ......................................................................................13 
6.1.4. 
Medical History ..........................................................................................................13 
6.1.5. 
Concomitant Medications ...........................................................................................13 
7. 
ANALYSIS OF SAFETY ..........................................................................................13 
7.1. 
Extent of Exposure .....................................................................................................14 
7.2. 
Adverse Events ...........................................................................................................14 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 5 
Version Date:  17 December 2019 
7.3. 
Safety Laboratory Parameters .....................................................................................15 
7.4. 
Vital Signs ..................................................................................................................15 
7.5. 
ECG Parameters ..........................................................................................................15 
7.6. 
Clinical Assessment of EBS Lesions ..........................................................................15 
8. 
INTERIM ANALYSIS ...............................................................................................15 
9. 
SAMPLE SIZE AND POWER CONSIDERATIONS ...............................................16 
10. 
CHANGES FROM THE PROTOCOL ......................................................................16 
 
LIST OF TABLES 
Table 1: Study Flow Chart ...............................................................................................................7 
 
LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AE  
Adverse Event 
AESI 
Adverse Event of Special Interest 
BSA 
Body Surface Area 
CSR 
Clinical Study Report 
DRESS 
Drug reaction with eosinophilia and systemic symptoms 
EBS 
Epidermolysis Bullosa Simplex 
eCRF 
Electronic Case Report Form 
eDiary 
Electronic Diary 
ICH 
International Conference on Harmonization  
MedDRA 
Medical Dictionary for Regulatory Activities 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOP 
Standard Operation Procedure 
TEAE 
Treatment-Emergent Adverse Event 
WHO 
World Health Organization 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 6 
Version Date:  17 December 2019 
1. 
INTRODUCTION 
The purpose of this document is to provide a description of the statistical methods and 
procedures to be implemented for the analysis of data from protocol number CCP-020-302. This 
document is based on the Global Protocol Amendment 3.1 document. If circumstances arise 
during the study such that more appropriate analytic procedures become available, the statistical 
analysis plan (SAP) may be revised. Any revisions to the SAP (both alternative and additional 
methods) will be made prior to database lock. Reasons for such revisions will be described in the 
final Clinical Study Report (CSR). 
2. 
OVERVIEW 
2.1. 
Objectives 
The primary objective of the study is to evaluate the long-term safety and tolerability of 
diacerein 1% ointment for 2 treatment cycles in subjects with epidermolysis bullosa simplex 
(EBS) that were previously enrolled in studies CCP-020-301 or CCP-020-101.  
2.2. 
Trial Design 
This is an international, multicenter, open-label, long term extension study evaluating the safety 
of topical diacerein 1% ointment for the treatment of subjects with EBS. At Baseline, EBS 
subjects who participated the CCP-020-301, double-blind safety and efficacy study or 
participated in the CCP-020-101, PK study (feeder studies) and who meet all the 
inclusion/exclusion criteria will be eligible to enroll in this study. 
At Baseline (corresponding to the final study visit of the feeder study), the investigator will 
perform a clinical assessment and determine if any of the subject’s lesions require treatment (up 
to 30% BSA). If the subject has active lesions as determined by the Investigator’s clinical 
assessment, the subject will initiate a cycle of once-daily, at home study medication application 
to their EBS lesions for 8 weeks (treatment period) followed by an 8-week period where no 
treatment will be administered. Subjects presenting with no active lesions as determined by the 
Investigator’s clinical assessment will not begin treatment and instead will be instructed to return 
to the clinic for re-evaluation in 8 weeks or upon worsening of EBS lesions, whichever happens 
first. 
Subjects/caregivers will apply the assigned study medication to all EBS lesions, including any 
new EBS lesions that develop (up to 30% BSA), once daily, every evening until the lesions 
resolve for 8 weeks. After 8 weeks, the subject will return to the site to return the study 
medication and remain off treatment for 8 weeks. The investigator will re-evaluate the subject 
after 8 weeks off therapy and if any of the subject’s lesions require treatment (up to 30% BSA) 
the subject will begin another treatment cycle for a maximum of two 8-week treatment cycles 
allowed in a 52 week period. 
Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, 
vital signs, ECG monitoring and adverse event monitoring. 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 7 
Version Date:  17 December 2019 
Subjects should be assessed at minimum every 8 weeks for disease activity. Once a subject 
completes two cycles of treatment or reaches Week 52, the subject will be discharged from the 
study. Subjects may not start a new treatment cycle past Week 36 without prior sponsor 
approval. The duration of a subject’s participation in the extension study may be as short as 32 
weeks or as long as 52 weeks depending on the cycle initiation schedule for each individual 
subject. 
A detailed schedule of procedures is provided in Table 1. 
Table 1: Study Flow Chart 
 
 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 8 
Version Date:  17 December 2019 
3. 
STUDY ENDPOINTS 
3.1. 
Safety Endpoints 
Safety will be evaluated in terms of the occurrence of adverse events (AEs) and changes in 
clinical laboratory parameters, clinical examination findings, electrocardiograms (ECGs), vital 
signs, weight, and urine measurements. 
3.1.1. 
Adverse Events 
Adverse events, which include clinical laboratory test variables, will be monitored and 
documented from the time the subject signs an informed consent AND has any study related 
procedure conducted, until the subject’s study participation is complete OR until 30 days after 
the subject’s last study medication application, whichever is longer. 
Adverse events that were reported in the CCP-020-301 or CCP-020-101 studies and are ongoing 
at Baseline for this study must be reported for this study. 
All AEs that occur after the first study medication application in the CCP-020-302 study will be 
considered treatment-emergent adverse events (TEAEs). 
In concert with system-organ classification (SOC) defined by Medical Dictionary for Regulatory 
Activities (MedDRA) the following AEs will be categorized as AEs of special interest (AESIs) 
in this study: 
 
Moderate to severe diarrhea 
 
Hepatic Injury 
 
Pancreatitis 
 
Urticaria/angioedema 
 
Epidermal necrolysis 
 
Drug reaction with eosinophilia and systemic symptoms (DRESS) 
 
Purpura/cutaneous vasculitis 
 
Jaundice 
 
Each AE shall be evaluated for the severity, seriousness, duration, resolution, action taken and its 
relationship with the study medication. 
3.1.2. 
Safety Laboratory Evaluations 
At the timepoints specified in the Study Flow Chart, a qualified staff member will collect blood 
and urine samples for clinical laboratory analysis.  
The results of the feeder studies (final visit) clinical laboratory samples will be used as the 
Baseline data for this study and need not be repeated unless the visit occurs outside the window 
allowed in the Study Flow Chart. 
The following tests will be performed: 
 
 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 9 
Version Date:  17 December 2019 
 
Chemistry Panel 
Complete Blood Count 
Albumin 
Hematocrit 
Alkaline phosphatase (ALP) 
Hemoglobin 
Alanine aminotransferase (ALT) 
Platelet count 
Amylase 
Red blood cell morphology 
Aspartate aminotransferase (AST) 
Red blood cell count 
Blood urea nitrogen (BUN) 
White blood cell count 
Bicarbonate 
White blood cell differential 
Chloride 
% and absolute: 
Creatinine 
Basophils 
Gamma-Glutamyl Transferase 
(G-GT) 
Glucose 
Eosinophils 
HbA1c 
Lymphocytes 
Lactate dehydrogenase (LDH) 
Monocytes 
Lipase 
Neutrophils 
Potassium 
Sodium 
Complete Urinalysis 
Total bilirubin 
Total protein 
Uric acid 
 
3.1.3. 
Vital Signs 
At the timepoints specified in the Study Flow Chart, a qualified staff member will measure each 
subject’s vital signs. The following items will be measured: 
 
Body temperature 
 
Pulse rate 
 
Respiration rate 
 
Blood pressure (systolic and diastolic) after the subject sits quietly for at least 5 minutes 
 
Height  
 
Weight 
The vital signs collected from the feeder studies (final visit) will be used as the Baseline data for 
this study and need not be repeated unless the visit occurs outside the window allowed in the 
Study Flow Chart. 
 
 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 10 
Version Date:  17 December 2019 
3.1.4. 
Electrocardiogram (ECG) Monitoring 
Single 12 lead ECGs will be performed as outlined in the Study Flow Chart using sensitive 
electrodes ensuring the subject’s skin is not harmed from the procedure (e.g. SofTouch™ 
Electrodes). The ECGs will be performed on subjects in supine position.  
The ECG corresponding to the final visit of the feeder studies will be used as the Baseline data 
for this study and need not be repeated. 
The following ECG data will be collected: 
 
Heart rate 
 
PR interval 
 
QRS duration 
 
QT interval 
 
RR interval 
 
Overall Interpretation 
 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 11 
Version Date:  17 December 2019 
4. 
ANALYSIS POPULATIONS 
4.1. 
Safety Population 
The Safety Population will consist of all subjects who receive at least one application of study 
drug. All safety summaries and analyses will be conducted using the Safety Population. 
5. 
GENERAL CONSIDERATIONS FOR DATA ANALYSIS 
Medpace is responsible for the statistical analyses for this trial. The statistical planning and 
conduct of analyses of the data from this trial will follow the principles defined in relevant ICH-
E9 guidelines and Medpace’s Biostatistics SOPs. All tables, figures, and listings will be 
generated with SAS® (SAS Institute Inc. Cary, North Carolina, USA) Version 9.3 or higher and 
printed using a Rich Text Format (RTF) file format. 
5.1.1. 
Summary Statistics 
Categorical data will generally be summarized with counts and percentages of subjects. The 
denominator used for the percentage calculation will be clearly defined. Continuous data will 
generally be summarized with descriptive statistics including n (number of non-missing values), 
mean, median, standard deviation, minimum, and maximum. 
5.1.2. 
Evaluation of Center Effect 
Due to the design, objectives, and sample size of the trial, center effects will not be evaluated. 
5.1.3. 
Assessment Windows and Analysis Day 
In the descriptive statistics of safety endpoints, only measurements from scheduled visits will be 
used in the analysis.  
For analysis purposes, if the event date is on or after the baseline/initial study visit date, the study 
day is defined as follows: 
Study Day = Event date – Initial study visit date + 1 
Therefore, the day of the first study visit will be Day 1. If the event date is prior to the initial 
study visit date, the addition of 1 will not be included in the calculations; thus, there will be no 
Day 0. 
5.1.4. 
Assessments Corresponding to Cycle 1 End and Cycle 2 Start 
When the End of Cycle visit corresponding to cycle one occurs on the same day as the Cycle 
Start visit corresponding to cycle two, the assessments will be analyzed in the following manner: 
 For adverse events having a start date on the Cycle 1 end date / the Cycle 2 start date, the 
adverse event will be attributed to Cycle 2. 
 For compliance assessments in which a subject reported applying study medication on the 
Cycle 1 end date / the Cycle 2 start date, the application will be attributed to Cycle 2. 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
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Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 12 
Version Date:  17 December 2019 
 For clinical assessments (during which the percent BSA of all active lesions that require 
treatment is determined) occurring on the Cycle 1 end date / the Cycle 2 start date, the 
assessment will be attributed to both the end of Cycle 1 and the start of Cycle 2 
timepoints, for the purposes of the summary analyses. 
5.1.5. 
Baseline Definition 
Unless otherwise stated, Baseline is defined as the final study visit of the feeder study, unless the 
Baseline visit is >7 days from the final visit of the feeder study. Baseline may be considered the 
Cycle Start Visit if the investigator determines the subject has lesions that require treatment. 
5.1.6. 
Missing Data 
5.1.6.1. 
Date Values 
In cases of incomplete dates (e.g. AE, concomitant medication, and medical history start and/or 
stop dates), the missing component(s) will be assumed as the most conservative value possible. 
For example, adverse events with missing start dates will be considered as treatment-emergent 
unless the partial date excludes that possibility, e.g. the adverse event month is prior to the initial 
treatment month during the study. Otherwise, the first day of the month will be used to impute 
missing start days and January will be used to impute missing start months. If day is missing for 
an end date, the last day of the month will be imputed. 
Date imputation will only be used for computational purposes such as treatment-emergent status, 
etc. Actual date values, as they appear in the original CRFs, will be presented within the data 
listings. 
5.1.6.2. 
Non-Date Values 
Every effort will be made to obtain required data at each scheduled evaluation from all subjects 
who have been enrolled. No imputation of missing data will be performed for non-date values.  
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 13 
Version Date:  17 December 2019 
6. 
SUBJECT DATA AND STUDY CONDUCT 
6.1.1. 
Subject Disposition  
Subject disposition information will be summarized. Counts (number and percent) of subjects 
who are enrolled, who are treated with study medication, who required a second treatment cycle, 
who complete the study, and who withdraw early from the study will be presented. The primary 
reasons for early withdrawals will also be tabulated. The Safety Population will be used as the 
denominator for the percentage calculations. Subject disposition, inclusion/exclusion criteria, and 
comments will be listed. 
6.1.2. 
Protocol Deviations  
Protocol deviations will be identified based on the clinical data as defined in the Protocol 
Deviation Plan. The Protocol Deviation Plan will define all protocol deviations as either CSR 
reportable or non-CSR reportable deviations. A listing of all CSR reportable protocol deviations 
will be provided. 
6.1.3. 
Demographic Characteristics 
Demographic and baseline characteristics will be summarized. Demographic and baseline 
characteristics include the following: age at informed consent, sex, and feeder study 
classification. Unless otherwise stated, all continuous variables will be represented by n, mean, 
standard deviation, minimum, median, and maximum. All categorical variables will be presented 
as counts and percentages. Demographic characteristics will also be listed. 
6.1.4. 
Medical History 
Medical history information will be listed. A listing of concomitant therapies/procedures will be 
provided. 
6.1.5. 
Concomitant Medications 
All medications administered during the study will be listed including the reported term, start 
and stop dates, and other relevant data will be provided. Concomitant medications include all 
medications taken on or after the date of the first study visit (Baseline). Prior medications include 
all medications taken and discontinued before the date of the first study visit (Baseline). All 
medications will be coded using the World Health Organization (WHO) Drug Sept 2016E B2 
version. 
7. 
ANALYSIS OF SAFETY 
Safety will be assessed using the Safety Population. The assessment of safety will include 
adverse events, clinical laboratory assessments, ECGs, clinical examination findings, and vital 
signs. Other safety data will be summarized as appropriate. 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020


 
Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
Page 14 
Version Date:  17 December 2019 
7.1. 
Extent of Exposure 
Study drug usage is based on data collected from the Drug Accountability eCRF where drug 
usage is calculated as the number of study drug tubes dispensed minus the number of study drug 
tubes returned. 
Percent compliance with the study medication will be summarized for the Safety Population 
using descriptive statistics. Compliance will be calculated as 100 x (Number of days study drug 
application was completed) / (Number of days study drug application was expected). The 
number of days application was completed is based on data collected from the subject’s eDiary. 
If no information is provided for a given day, it will be assumed that the subject did not complete 
the application. The number of days application was expected is as follows: (Date of Mid-Cycle 
Visit – Date of Cycle Start), i.e. the number of days study drug was expected to be applied in the 
8-week treatment period. If the subject did not have a Mid-Cycle Visit then 56 expected days 
(8 weeks) of application will be assigned for the analysis. If a subject had 2 treatment cycles, the 
number of expected days from each treatment cycle will be calculated as described above and 
summed for a total number of days study drug application was expected across both treatment 
cycles.  
Compliance will be summarized for each treatment cycle and overall. If no information is 
provided for any day within a given treatment cycle, then the compliance within that cycle will 
be set to missing. For subjects that had missing compliance within a given cycle, their overall 
compliance will be based on only the cycle for which information is provided in the eDiary. 
The analysis will include listings for drug exposure and compliance. 
7.2. 
Adverse Events 
Adverse events will be coded using the MedDRA version 19.0 and summarized by system organ 
class and preferred term.  
A summary overview of TEAEs will be provided which presents the number and percentage of 
subjects satisfying each of the following categories:  
 
All AEs, 
 
All TEAEs, 
 
Drug-related TEAEs, 
 
Maximum severity of TEAEs, 
 
All AESIs, 
 
All treatment-emergent SAEs, 
 
Death due to TEAEs, and 
 
TEAEs leading to study drug discontinuation. 
Similar summary overviews will be provided for TEAEs occurring during Cycle 1 (defined as 
TEAEs beginning on or after the start of Cycle 1 through the end of Cycle 1) and Cycle 2 
(defined as TEAEs beginning on or after the start of Cycle 2 through the end of Cycle 2). 
The numbers and percentages of subjects with TEAEs will be summarized by MedDRA 
preferred term within system organ class. For the summaries, multiple AEs with the same 
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MedDRA preferred term within system organ class from the same subject will only be counted 
once. 
All TEAEs related to study drug, AESIs, SAEs, and AEs leading to study drug discontinuation 
will be summarized in the same manner. 
All AEs will be included in subject listings containing additional information of interest such as 
onset and resolution times, maximum severity, causal relationship to study medication, and 
action taken. Specific subject listings of TEAEs, related to study drug, AESI, SAEs, and TEAEs 
leading to study discontinuation will be provided. 
7.3. 
Safety Laboratory Parameters 
Clinical laboratory results will be summarized with descriptive statistics by visit. Change from 
baseline will also be summarized. Laboratory values will also be listed by visit, within subject. 
7.4. 
Vital Signs 
Vital signs and the change from baseline will be summarized descriptively by visit. The count 
and percentage of subjects with abnormal values will be summarized by visit. Abnormal blood 
pressure measurements for subjects age 17 and younger will be defined as either systolic or 
diastolic measurements above the 95th percentile, according to height, sex, and age. Abnormal 
blood pressure measurements for subjects age 18 and older will consist of either a systolic blood 
pressure >140mm Hg or a diastolic blood pressure >90mm Hg. Abnormal weight measurements 
for subjects age 18 and older will be defined as measurements > 300 pounds (>118 kilograms). 
Abnormal BMI measurements for subjects age 17 and younger will be defined as measurements 
above the 95th percentile, according to sex and age. Vital sign data will also be listed by visit, 
within subject. 
7.5. 
ECG Parameters 
Electrocardiogram results will be summarized by visit. Electrocardiogram results will also be 
listed. 
7.6. 
Clinical Assessment of EBS Lesions 
The numbers and percentages of subjects with active EBS lesions requiring treatment will be 
summarized by visit. The percent BSA of active lesions requiring treatment will be summarized 
with descriptive statistics by visit. Change from baseline and the percent change from baseline 
will also be summarized. The clinical assessment findings will also be listed by visit, within 
subject. 
8. 
INTERIM ANALYSIS 
No interim analysis is planned for this extension study. 
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Statistical Analysis Plan 
 
Protocol Number: CCP-020-302   
Version Number: 1.0 
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Version Date:  17 December 2019 
9. 
SAMPLE SIZE AND POWER CONSIDERATIONS 
No formal sample size calculation was performed for this extension study. The actual number of 
subjects that are enrolled will depend on the final number of subjects who participate in the 
CCP-020-301 or participate in the CCP-020-101 study. 
10. 
CHANGES FROM THE PROTOCOL 
The Day 0/Baseline visit was reclassified in the SAP compared to the protocol. The SAP refers 
to the initial visit in the study as the Baseline visit and this will correspond to Study Day 1 in the 
analysis. 
Castle Creek Pharmaceuticals, LLC 
Clinical Study Report CCP-020-302
Confidential & Proprietary 
Version 1.0, 08 July 2020