Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-126 Gel; IDP-126 Vehicle Gel
Intervention description: IDP-126 Gel applied topically to the face once daily for 12 weeks.; IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle
      Gel at Weeks 2, 4, 8, and 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 9 years of age and older.

          -  Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit).

          -  Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4
             (severe) at the baseline visit.

          -  Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 30, but no more than 100.

          -  Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count
             no less than 35, but no more than 150.

          -  Subjects with 2 or fewer facial nodules.

        Exclusion Criteria:

          -  Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis,
             eczema.

          -  Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          -  Subjects with more than 2 facial nodules.

          -  Female subjects who are pregnant, nursing mothers, planning a pregnancy during the
             course of the study, or become pregnant during the study.

          -  Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than
             12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more
             consecutive weeks immediately prior to study entry need not be excluded unless the
             subject expects to change dose, drug or discontinue estrogen use during the study.

          -  Treatment of any type of cancer within the last 6 months, with the exception of
             complete surgical excision of skin cancer outside the treatment area.

          -  Subjects who have not undergone specified washout period(s) for topical
             preparations/physical treatments used on the face or subjects who require the
             concurrent use in the treatment area.

          -  Subjects who have not undergone specified washout period(s) for systemic medications
             or subjects who require the concurrent use of systemic medications.

          -  Subjects with any underlying disease that the investigator deems uncontrolled, and
             poses a concern for the subject's safety while participating in the study.