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A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne - NCT00964223-48088(Clinical Trial 306736)



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City:  Warren
State:  
MI
Zip Code: 48088
Conditions: Acne Vulgaris
Purpose: 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.
Study summary: 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.
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.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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