Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene and Benzoyl Peroxide Topical Gel; Epiduo Topical Product; Placebo
Intervention description: Test product; RLD product; Placebo gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 825.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      To compare the safety and efficacy of Perrigo's product to an FDA approved product for the
      treatment of Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed IRB approved written informed consent/assent

          2. 12 to 40 years of age, inclusive.

          3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and
             pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones)
             lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g.,
             nodules and cysts) including those present on the nose.

          4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a
             severity scale of 0 to 4.

          5. Females of child bearing potential (excluding women who are surgically sterilized
             (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at
             least 2 years), in addition to having a negative urine pregnancy test at Visit
             1/Day1(Baseline), must be willing to use an acceptable form of birth control during
             the study.

        Exclusion Criteria:

          1. Pregnant, breastfeeding or planning a pregnancy within the period of their study
             participation period.

          2. Presence of more than 2 facial Nodulocystic lesions.

          3. Presence of any other facial skin condition that, in the Investigator's opinion, might
             interfere with acne vulgaris diagnosis and/or evaluations

          4. Any uncontrolled, chronic or serious disease or medical condition that would prevent
             participation in a clinical trial, or, in judgment of the investigator, would put the
             subject at undue risk or might confound the study assessments

          5. Excessive facial hair that would interfere with the diagnosis or assessment of acne
             vulgaris.

          6. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.

          7. Currently using any product containing adapalene and/or benzoyl peroxide and/or
             belonging to the same family.

          8. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids
             and/or any ingredient in the study medication.

          9. Use of medications known to exacerbate acne

         10. Start or change within 3 months (90 days) of Visit 1 and throughout the study

         11. Use of medicated make-up throughout the study and significant change in the use of
             consumer products within 30 days (1 month) of study entry and throughout the study

         12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could
             compromise the subject's ability to comply with study requirements.

         13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the
             restrictions of the protocol and complete the study.