Clinical trial NCT02938494: 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, in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-19
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: Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Detailed description: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Eligibility criteria: Key Inclusion Criteria:

* Male or female at least 12 years of age and older.
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
* Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema.
* 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.
* Evidence or history of cosmetic-related acne.
* Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

Primary outcomes:
measure: Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
timeFrame: Baseline (Day 0), Week 12
measure: Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Treatment Success at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Valeant Site 03
state: California
city: Fremont
country: United States
facility: Valeant Site 04
state: California
city: Los Angeles
country: United States
facility: Valeant Site 06
state: California
city: Sacramento
country: United States
facility: Valeant Site 14
state: California
city: Santa Monica
country: United States
facility: Valeant Site 01
state: California
city: Colorado Springs
country: United States
facility: Valeant Site 05
state: Colorado
city: Coral Gables
country: United States
facility: Valeant Site 08
state: Florida
city: Miami
country: United States
facility: Valeant Site 10
state: Florida
city: Miramar
country: United States
facility: Valeant Site 09
state: Florida
city: Louisville
country: United States
facility: Valeant Site 12
state: Kentucky
city: Louisville
country: United States
facility: Valeant Site 13
state: Kentucky
city: Rockville
country: United States
facility: Valeant Site 02
state: Maryland
city: Fridley
country: United States
facility: Valeant Site 07
state: Minnesota
city: Chapel Hill
country: United States
facility: Valeant Site 16
state: North Carolina
city: High Point
country: United States
facility: Valeant Site 15
state: North Carolina
city: Philadelphia
country: United States
facility: Valeant Site 11
state: Pennsylvania
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References: