A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Key facts

Study ID

NCT00964223

Run by

Stiefel, a GSK Company

People needed

28

Starts

2009-07-01

Expected to finish

2009-11-01

Last updated by the study team

2016-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
• Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
• Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.

You may not qualify if…

• Female subjects who are pregnant, trying to become pregnant or breastfeeding.
• Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
• Facial hair that may obscure the accurate assessment of acne grade.
• History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
• Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
• Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
• Use of systemic retinoids within the past 6 months.
• Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
• Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
• Use of topical anti-acne medications within the past 2 weeks.
• Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.

Where it is running

• Aesthetics, Skin Care & Dermasurgery — Rockville, Maryland, United States
• Grekin Skin Institute — Warren, Michigan, United States

Full record on ClinicalTrials.gov

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