A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valeant Pharmaceuticals

Criteria

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 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 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

• Concomitant use of potentially irritating over-the-counter products