Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo
Condition: Acne
Intervention: Tretinoin; placebo
Intervention description: Treatment of acne; treatment of acne
Intervention MeSH terms: Tretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 958.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear
      Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
    

Eligibility criteria:

        A subject will be eligible to participate if they meet all of the following inclusion
        criteria:

          -  Normal, healthy male and female children and adults.

          -  Age 12 to 40 years.

          -  Written and verbal informed consent must be obtained. Subjects age 12 to 17
             (inclusive) must sign an assent for the study and a parent or a legal guardian must
             sign the informed consent (per FDA letter 8.21.07).

          -  Women of child-bearing potential must be non-pregnant and non-nursing, and must be
             willing to avoid pregnancy during the course of the study and during the menstrual
             cycle following completion of their participation in the study, adequate contraception
             is defined as regular use of any two of the following: oral, injectable
             contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive
             patches. (oral contraceptives if used for at least three months and injectable
             contraceptives if used for at least 6 months)- prior to enrollment in the study, or
             abstinence.

          -  Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and
             closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per
             FDA letter 8.21.07).

          -  Global severity score from 2-4

          -  Able to refrain from the use of all other topical acne medications or antibiotics
             during the treatment period.

          -  Considered reliable and capable of understanding their responsibility and role in the
             study.

        Exclusion Criteria

        A subject will be eligible to participate if they meet none of the following exclusion
        criteria:

          -  Subjects with active cystic acne as evidenced by more than 2 facial nodules.

          -  More than 40 papules and/or pustules (inflammatory lesions)

          -  More than 60 open and or closed comedones/milia (non-inflammatory lesions)

          -  Overall severity grade of less than 2 or greater than 4,

          -  History of allergy or hypersensitivity to tretinoin.

          -  Significant history or clinical evidence of auto-immune, cardiovascular,
             gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease

          -  Use of systemic retinoid treatment within six months prior to study initiation.

          -  Oral contraceptives should not be started or changed within 3 months prior to study
             initiation or planned to change during the study.

          -  Pregnant or breast-feeding.

          -  Participation in a clinical study for acne within 4 months preceding study initiation.