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

Condition(s) targeted: Acne Vulgaris

Intervention: clindamycin and benzoyl peroxide gel (Duac® Topical Gel) (Drug); benzoyl peroxide and adapalene gel (EPIDUO™ Gel) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
Lou Barbato, MD, Study Director, Affiliation: Stiefel, a GSK Company

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.

Official title: A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: To compare the tolerability of clindamycin and benzoyl peroxide gel to benzoyl peroxide/adapalene gel in the treatment of facial acne during the first 2 weeks of treatment.

Secondary outcome: To evaluate efficacy, tolerability, safety and subject satisfaction of clindamycin and benzoyl peroxide gel in the treatment of acne vulgaris. To evaluate the influence of acne on subjects' quality of life.

Detailed description: Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. 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.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Aesthetics, Skin Care & Dermasurgery, Rockville, Maryland 20850, United States; Recruiting
Green, Phone: 301-610-0663
Lawrence Green, MD, Principal Investigator

Grekin Skin Institute, Warren, Michigan 48088, United States; Recruiting
Grekin, Phone: 586-759-5525
Steven K Grekin, DO, Principal Investigator

Starting date: July 2009
Ending date: October 2009
Last updated: August 21, 2009