A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: BENZOYL PEROXIDE/ CLINDAMYCIN; BENZOYL PEROXIDE/ ADAPALENE
Intervention description: Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.; Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Acne; Acne Vulgaris

Summary:

      The purpose of this study is to compare the tolerability of topical combination therapies in
      the treatment of facial acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects at least 21 years of age, in good general health with
             documented diagnosis of acne vulgaris.

          -  Female subjects of childbearing potential must have a negative pregnancy test.
             Sexually active women of childbearing potential participating in the study must use a
             medically acceptable form of contraception Abstinence is considered an acceptable
             method of contraception.

          -  Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones)
             facial lesions.

          -  The ability and willingness to follow all study procedures, attend all scheduled
             visits, and successfully complete the study

          -  Capable of understanding and willing to provide signed and dated written voluntary
             informed consent (and any local or national authorization requirements) 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 other
             than acne vulgaris.

          -  History or presence of regional enteritis or inflammatory bowel disease (eg,
             ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of
             antibiotic-associated colitis) or similar symptoms.

          -  Use of topical antibiotics or anti-acne medications 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.

          -  Facial procedures performed by an esthetician, beautician, physician, nurse, or other
             practitioner, within the past 4 weeks or during the conduct of the study.

          -  Known hypersensitivity or previous allergic reaction to any of the active components,
             lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study
             product.