Clinical trial NCT02886715: A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-01
Enrollment: 1110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
* Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Primary outcomes:
measure: Change in Inflammatory Lesion Counts
timeFrame: Week 12
measure: Change in Non-inflammatory Lesion Counts
timeFrame: Week 12
Secondary outcomes:
measure: Clinical Response of Success
timeFrame: Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Fougera Investigational Site
state: Arizona
city: Conway
country: United States
facility: Fougera Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Fougera Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Fougera Investigational Site
state: California
city: La Mesa
country: United States
facility: Fougera Investigational Site
state: California
city: Long Beach
country: United States
facility: Fougera Investigational Site
state: California
city: Long Beach
country: United States
facility: Fougera Investigational Site
state: California
city: Los Angeles
country: United States
facility: Fougera Investigational Site
state: California
city: North Hollywood
country: United States
facility: Fougera Investigational Site
state: California
city: San Diego
country: United States
facility: Fougera Investigational Site
state: California
city: San Ramon
country: United States
facility: Fougera Investigational Site
state: California
city: Upland
country: United States
facility: Fougera Investigational Site
state: California
city: West Covina
country: United States
facility: Fougera Investigational Site
state: California
city: Coral Gables
country: United States
facility: Fougera Investigational Site
state: Florida
city: Miami Gardens
country: United States
facility: Fougera Investigational Site
state: Florida
city: Miami
country: United States
facility: Fougera Investigational Site
state: Florida
city: Miami
country: United States
facility: Fougera Investigational Site
state: Florida
city: Miramar
country: United States
facility: Fougera Investigational Site
state: Florida
city: Sweetwater
country: United States
facility: Fougera Investigational Site
state: Florida
city: Plainfield
country: United States
facility: Fougera Investigational Site
state: Indiana
city: High Point
country: United States
facility: Fougera Investigational Site
state: North Carolina
city: Hazleton
country: United States
facility: Fougera Investigational Site
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Fougera Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Fougera Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Fougera Investigational Site
state: Texas
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C. Kaplan
role: STUDY_DIRECTOR
References: