Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007. Types of locations: Dermatology Clinics, Dermatology Research Centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).

Reporting Groups

	Description
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Gel	Adapalene Topical Gel
Benzoyl Peroxide Gel	Benzoyl Peroxide Topical Gel
Gel Vehicle	Topical Gel Vehicle

Participant Flow:   Overall Study

	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle
STARTED	419	418	415	418
COMPLETED	366	369	363	361
NOT COMPLETED	53	49	52	57
Withdrawal by Subject	22	23	23	24
Lost to Follow-up	18	19	22	20
Adverse Event	11	1	6	4
Protocol Violation	2	2	0	1
Lack of Efficacy	0	3	0	5
Pregnancy	0	1	1	2
Subject transportation issues	0	0	0	1

Reporting Groups

	Description
Adapalene/Benzoyl Peroxide Gel	Adapalene/Benzoyl Peroxide Topical Gel
Adapalene Gel	Adapalene Topical Gel
Benzoyl Peroxide Gel	Benzoyl Peroxide Topical Gel
Gel Vehicle	Topical Gel Vehicle

Baseline Measures

	Adapalene/Benzoyl Peroxide Gel	Adapalene Gel	Benzoyl Peroxide Gel	Gel Vehicle	Total
Number of Participants   [units: participants]	419	418	415	418	1670
Age   [units: years] Mean ± Standard Deviation	19.5 ± 6.7	18.5 ± 6.3	18.9 ± 6.96	19.2 ± 7.23	19 ± 6.81
Age, Customized   [units: participants]
12-17 years	233	241	244	243	961
Between 18 and 64 years	186	177	171	175	709
>=65 years	0	0	0	0	0
Gender   [units: participants]
Female	236	229	230	244	939
Male	183	189	185	174	731
Region of Enrollment   [units: participants]
United States	185	185	179	185	734
Canada	102	100	100	101	403
Europe	132	133	136	132	533

1.  Primary:

Success Rate on the Investigator's Global Assessment   [ at week 12 ]

2.  Primary:

Changes in Inflammatory Lesion Counts   [ from Baseline to week 12 ]

3.  Primary:

Changes in Noninflammatory Lesion Counts   [ from Baseline to week 12 ]

4.  Secondary:

Percent Change in Inflammatory Lesion Counts   [ at week 12 ]

5.  Secondary:

Percent Change in Noniflammatory Lesion Counts   [ at week 12 ]

6.  Secondary:

Percent Change in Total Lesion Counts   [ at week 12 ]