Conditions: Acne
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1180
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate the efficacy and safety of Perrigo's test formulation of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% compared to the already marketed formulation, Acanya gel in patients with acne vulgaris.

Detailed description:

Arms:
arm 1: Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily. arm 2: Acanya Gel applied to the affected areas of the face once daily. arm 3: Placebo of the Test product applied to the affected areas of the face once daily.

Interventions: intervention 1: Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% intervention 2: Acanya Gel intervention 3: Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document:
Prot_001.pdf: 
 
 
NCT01796665 
 
02-09-2012 









































































































SAP_000.pdf: 
 
 
NCT01796665 
 
02-09-2012 








Perrigo Pharmaceuticals, Ltd.                                                                                                       Protocol: PRG-NY-12-005 
                                                                                                                                                                     
 
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 
 
 
 
Page 5 of 54














Perrigo Pharmaceuticals, Ltd.                                                                                                       Protocol: PRG-NY-12-005 
                                                                                                                                                                     
 
10  
CONFIDENTIAL 
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: 
- 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. 
Page 12 of 54