Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-123 Lotion; Tazorac Cream; Vehicle Lotion; Vehicle Cream
Intervention description: Lotion; Cream; Lotion; Cream
Intervention MeSH terms: Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream,
      0.1%, in the Treatment of Acne Vulgaris
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female at least 12 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).

          -  Women of childbearing potential and females that are pre-menses must be willing to
             practice effective contraception for the duration of the study. (Effective
             contraception is defined as stabilized on oral contraceptive for at least 3 months,
             IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring,
             injection, transdermal patch or abstinence.) Females on birth control pills must have
             taken the same type pill for at least three months prior to entering the study and
             must not change type during the study. Those who have used birth control pills in the
             past must have discontinued usage at least three months prior to the start of the
             study. Women who use birth control for acne control only should be excluded.

          -  Pre-menses females and women of childbearing potential must have a negative urine
             pregnancy test at the screening and baseline visits.

        Key Exclusion Criteria:

          -  Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          -  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, gramnegative 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 a facial beard or mustache that could interfere with the study
             assessments.

          -  Evidence or history of cosmetic-related acne.

          -  Subject has a history of experiencing significant burning or stinging when applying
             any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their
             face.