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