Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin and benzoyl peroxide; benzoyl peroxide 2.5% and adapalene 0.1% gel
Intervention description: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.; Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel
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 (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      This is a single-blind (blinded expert grader), randomized, half-face study being conducted
      at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products,
      antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral
      side of the face will remain non-treated to serve as a control. Approximately 25-30 male and
      female healthy subjects will be randomly assigned to each product
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 to 45 years of age or older, able to complete the study and comply with
             study instructions.

          -  Female subjects of childbearing potential must have a negative pregnancy test.
             Sexually active women of childbearing potential participating in the study must have
             been using a medically acceptable form of contraception

          -  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.

          -  Is willing to discontinue use of all facial products (other than the cleanser provided
             and makeup or razor and facial shave product) on the face for the 3 days before their
             baseline/day 0 visit and use only the provided facial products and their normal makeup
             or razor and facial shaving product for the duration of the study.

          -  Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure.
             Understands that if their skin tone changes significantly during the study it will be
             necessary to discontinue their participation.

        Exclusion Criteria:

          -  Male subjects that have facial beards (mustache and/or goatee is acceptable).

          -  Is a Type I diabetic.

          -  Has active or chronic skin allergies.

          -  Has a history of acute or chronic disease that might interfere with, or increase the
             risk of study participation.

          -  Has participated in other facial studies in the preceding 30 days or other clinical
             studies in preceding 14 days.

          -  Had skin cancer treatment in preceding 12 months.

          -  Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).

          -  Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to
             facial areas in preceding 12 months.

          -  Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8
             weeks of the baseline visit.

          -  Live in the same household as currently enrolled subjects.

          -  Any other condition or factor the investigator or his duly assigned representative
             believes may affect the skin response or the interpretation of the test results.