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

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valeant Pharmaceuticals
• Treatments: Nicotinic Acids; Tazarotene

Criteria

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