A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
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.
This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week
 study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as
 well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with
 moderate to severe acne. IDP-121 is a lotion 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 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