A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
 to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
 Vehicle Lotion.
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
 to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle
 Lotion. To be eligible for the study subjects must be at least 9 years of age and have a
 clinical diagnosis of moderate to severe acne.
Inclusion Criteria:

 1. Male or female at least 9 years of age and older;

 2. 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);

 3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
 Severity assessment at the baseline visit;

 4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
 no less than 20 but no more than 50;

 5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
 less than 25 but no more than 100;

 6. Subjects with two or fewer nodules

 Exclusion Criteria:

 1. Use of an investigational drug or device within 30 days of enrollment or participation
 in a research study concurrent with this study;

 2. 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;

 3. 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;

 4. Subjects with a facial beard or mustache that could interfere with the study
 assessments;

 5. Subjects with more than two (2) facial nodules;

 6. Evidence or history of cosmetic-related acne