Clinical trial NCT02535871: A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 800
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Absolute change in inflammatory lesion count from baseline to Week 12
timeFrame: 12 weeks
measure: Absolute change in non-inflammatory lesion count from baseline to Week 12
timeFrame: 12 weeks
measure: Proportion of subjects who have a least a 2 grade reduction at Week 12 from baseline in the Evaluator's Global Severity Score and were Clear or Almost Clear
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change in inflammatory lesion count from baseline to Week 4, 8, and 12
timeFrame: 4, 8, and 12 weeks
measure: Percent change in non-inflammatory lesion count from baseline to Week 4, 8, and 12
timeFrame: 4, 8, and 12 weeks
measure: Proportion of subjects who have a least a 2 grade reduction at Week 4, 8, and 12 from baseline in the Evaluator's Global Severity Score
timeFrame: 4, 8, and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric, MS
role: STUDY_DIRECTOR
References: