Clinical trial NCT02525549
Conditions: Acne
Sponsor: Padagis LLC
Start date: 2011-12-01; Completion date: 2012-08-01
Enrollment: 903 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to an FDA approved product for the treatment acne vulgaris.

Detailed description:

Arms: arm 1: Adapalene and Benzoyl Peroxide Gel arm 2: Adapalene and Benzoyl Peroxide Gel (Reference) arm 3: Placebo gel
Interventions: intervention 1: Adapalene and Benzoyl Peroxide Gel intervention 2: Adapalene and Benzoyl Peroxide Gel (Reference) intervention 3: Placebo gel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_001.pdf: 
 
 
NCT02525549 
 
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SAP_000.pdf: 
 
 
NCT02525549 
 
10-01-2012 








Perrigo Pharmaceuticals, Ltd.                                                                                                                   Protocol: PRG-817 
                                                                                                                                                                   
 
3  
CONFIDENTIAL 
List of Abbreviations 
 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
CI 
Confidence Interval 
CMH 
Cochran-Mantel Haenszel 
IGA 
Investigator’s Global Assessment 
ITT 
Intent to treat population 
LOCF 
Last Observation Carried Forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intent To Treat population 
PD 
Protocol Deviation 
PP 
Per protocol population 
PV 
Protocol Violation 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
TEAE 
Treatment-Emergent Adverse Event 
TESAE 
Treatment-Emergent Serious Adverse Event 
WHO Drug 
World Health Organization Drug Dictionary 
 
 
 
 
 
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Perrigo Pharmaceuticals, Ltd.                                                                                                                   Protocol: PRG-817 
                                                                                                                                                                   
 
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CONFIDENTIAL 
(Date of last application of study medication) - (Date of first application of study medication) 
+ 1. 
Medication compliance rate (%) will be calculated for each subject as follows: 
(Total number of applications used) / (Expected number of applications) *100%. 
Subjects who complete the study are expected to have 84 applications,
 
. For prematurely discontinued 
subjects, expected number of applications will be determined based on the expected number of 
applications by the time of discontinuation, i.e. the overall duration of treatment. Descriptive 
summaries of exposure and medication compliance rate will be provided by treatment group 
for the ITT subjects 
Adverse Events 
Adverse events (AEs) will be coded in MedDRA, version 14.0 or higher. Treatment-Emergent 
Adverse Event (TEAE) is defined as any AE occurs on or after applying the first dose of study 
drug. Number and percent of subjects reporting TEAEs will be tabulated by treatment group. 
Summaries will be presented by body system and preferred term for the ITT population. 
Similar tables will be presented by severity and relationship to study drug. TEAEs reported by 
more than 5% subjects for any treatment group will also be summarized. In summaries of 
incidence rates (frequencies and percentages), severity and relationship to study drug of 
individual, subjects who report more than one event that are mapped to the same preferred 
term will be counted only once under the strongest severity and relationship, accordingly.  The 
difference between Test and Reference treatments with regard to the severity and frequency of 
their dermatological adverse events will be statistically evaluated. Fisher’s exact test will be 
used to compare the proportions of subjects of the two active treatment groups who report any 
TEAE. 
Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs that led to treatment 
interruption or discontinuation will be presented in data listings. 
 
Concomitant Medications 
Concomitant medications will be coded using the WHO Drug Dictionary, version March, 
2011 or higher, and will be presented in data listings. 
 
Application Site Reactions 
Frequency and distribution of application site reactions of erythema, dryness, peeling, 
burning/stinging, erosion, edema, pain and pruritus will be summarized and compared 
descriptively by visit. 
 
Safety comparisons will be performed only for the ITT population. 
6 
Appendices 
6.1 
Handling of Missing or Incomplete Dates for Adverse Events and Concomitant Medications 
Adverse Events 
Handling of partial dates is only considered for the start date. An adverse event with a partial 
start date is considered treatment emergent if: 
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Perrigo Pharmaceuticals, Ltd.                                                                                                                   Protocol: PRG-817 
                                                                                                                                                                   
 
10  
CONFIDENTIAL 
- only the day is missing and the start month/year is the same or after the month/year of the 
first dose 
- the day and month are missing and the start year is the same or greater than the year of the 
first dose date 
- the start date is completely missing 
Concomitant Medications 
Handling of partial dates is only considered for the stop date. A medication with a partial stop 
date is considered concomitant if: 
- 
only the day is missing and the stop month/year is the same or after the month/year of the 
first dose 
- 
the day and month are missing and the stop year is the same or greater than the year of the 
first dose date 
- 
the stop date is completely missing or the medication is ongoing 
6.2 
Summary of Assessments 
The schedule of visits and procedures to be conducted at each visit are summarized in the 
Schedule of Study Procedures. 
 
 
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