A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

Inclusion Criteria:

• Male or female at least 9 years of age and older
• Written and verbal informed consent must be obtained.
• Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
• Subjects must be willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

• Any dermatological conditions on the face that could interfere with clinical evaluations
• 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
• Subjects who are unable to communicate or cooperate with the Investigator
• Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study