Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: GDC 268 Lotion; Clindamycin Phosphate Lotion 1%; GDC Vehicle Lotion
Intervention description: GDC 268 is a topical lotion; Clindamycin Phosphate Lotion is an FDA-approved drug product; GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1236.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: zits; pimples; blackheads

Summary:

      The objective of the study is to evaluate the safety, tolerability, and therapeutic
      equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the
      efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of
      acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
             diagnosis of acne vulgaris.

          -  Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20
             but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions
             (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at
             Baseline.

          -  Must be willing and able to refrain from use of all other topical products in the
             treatment area, all acne medications other than test article, and all antibiotics
             (other than test article) during the 12-week treatment period.

          -  Women must be surgically sterile, or use an effective method of birth control with a
             negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).

          -  In good general health and free of any other clinically significant disease state or
             physical condition.

          -  Subject has provided written informed consent / assent.

        Exclusion Criteria:

          -  Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed
             during the study.

          -  Subject has more than 2 facial nodular lesions; any nodules present will be documented
             but not included in the inflammatory lesion count for analysis.

          -  Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial
             tattoos, or other facial attributes that would interfere with diagnosis or assessment
             of acne vulgaris in the opinion of the investigator.

          -  Subject is planning surgery during the study.

          -  Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin
             and/or any of the ingredients in the test articles.

        Other Eligibility Criteria not listed above will be reviewed for each prospective subject
        by the study staff.