Clinical trial NCT02886702: A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-01
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_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 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
* Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index \[PASI\]). The most severe lesion at baseline should be identified as the target lesion
* Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Exclusion Criteria:

* A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
* Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
* Have a history of psoriasis unresponsive to topical treatments

Primary outcomes:
measure: Treatment Success Assessed by IGA
timeFrame: Week 12
Secondary outcomes:
measure: Disease Severity None or Minimal on IGA
timeFrame: Week 12
measure: Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Fougera Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Fougera Investigational Site
state: Arkansas
city: Anaheim
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: Brandon
country: United States
facility: Fougera Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Fougera Investigational Site
state: Florida
city: Hialeah
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: 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: Tampa
country: United States
facility: Fougera Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Fougera Investigational Site
state: Florida
city: Macon
country: United States
facility: Fougera Investigational Site
state: Georgia
city: Arlington Heights
country: United States
facility: Fougera Investigational Site
state: Illinois
city: New Albany
country: United States
facility: Fougera Investigational Site
state: Indiana
city: Plainfield
country: United States
facility: Fougera Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Fougera Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Fougera Investigational Site
state: Louisiana
city: Saint Joseph
country: United States
facility: Fougera Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Fougera Investigational Site
state: Nevada
city: High Point
country: United States
facility: Fougera Investigational Site
state: North Carolina
city: Salem
country: United States
facility: Fougera Investigational Site
state: Oregon
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: San Antonio
country: United States
facility: Fougera Investigational Site
state: Texas
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C. Kaplan
role: STUDY_DIRECTOR
References: