Clinical trial NCT02525822: Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 210
Sex: ALL
Minimum age (years): 12
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 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Absolute change in mean inflammatory lesion counts at Week 12
timeFrame: 12 weeks
measure: Absolute change in mean non-inflammatory lesion counts at Week 12
timeFrame: 12 weeks
measure: Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.
timeFrame: 2, 4, 8, and 12 weeks
measure: Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.
timeFrame: 2, 4, 8, and 12 weeks
measure: The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.
timeFrame: 2, 4, 8, and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric, MS
role: STUDY_DIRECTOR
References: