A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel); benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Intervention description: Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.; Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acne vulgaris

Summary:

      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.
    

Eligibility 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.