Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream 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-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Inclusion Criteria:

• Male or female at least 12 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
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the 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 subjects safety while participating in the study