Condition(s) treated: Acne Vulgaris

Intervention: adapalene gel, 0.3% (Drug); clindamycin/benzoyl peroxide gel (Drug)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: Galderma Laboratories, L.P.

Principal investigator(s) or official(s):
Ron W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Overall contact:
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0. 3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Official title: A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Percent change from baseline in total lesion counts at Week 12 (Time Frame: 12 weeks)

Secondary outcome:
Percent change from baseline in total lesion counts at Week 6 (Time Frame: 6 weeks)

Percent change from baseline in inflammatory and non-inflammatory lesion counts at Weeks 6 and 12 (Time Frame: 6 and 12 weeks)

Global severity assessment at Weeks 6 and 12 (Time Frame: 6 and 12 weeks)

Global assessment of Improvement from baseline at Week 12 (Time Frame: 12 weeks)

Tolerability assessments and incidence of adverse events (Time Frame: 12 weeks)

Detailed description: Same as above.

Minimum eligible age: 12 Years. Maximum eligible age: 35 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

1. Subjects with a minimum of 20 inflammatory lesions on the face;

2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;

3. Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com

Center for Dermatology and Laser Surgery, Sacramento, California 95819, United States; Recruiting
Regan Johnson, Phone: 916-454-5922, Email: dictationet@mgci.com
Emil A Tanghetti, MD, Principal Investigator

Derm Research, P.L.L.C., Louisville, Kentucky 40217, United States; Completed

Brodell Medical, Warren, Ohio 44483, United States; Recruiting
Sandra Treleven, Phone: 330-393-4000, Email: Sltreleven@aol.com
Robert T Brodell, MD, Principal Investigator

Northwest Cutaneous Research Specialists, Portland, Oregon 97210, United States; Recruiting
Kristen Reid, Phone: 503-226-3376, Email: reidkri@gmail.com
Phoebe Rich, MD, Principal Investigator

Start date: December 2007
End date: May 2008
Last updated: April 30, 2008

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