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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886702
• Other study ID #: 0453-01-01
• Secondary ID: 0453
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2016
• Est. completion date: August 2, 2017

Study information

• Verified date: July 2018
• Source: Fougera Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 855
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Tazarotene Cream 0.05%
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
• TAZORAC® (tazarotene) Cream 0.05%
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
• Placebo
Placebo (vehicle of the test product) to cover only the lesions with a thin film.

Locations

Country	Name	City	State
United States	Fougera Investigational Site	Anaheim	California
United States	Fougera Investigational Site	Arlington Heights	Illinois
United States	Fougera Investigational Site	Brandon	Florida
United States	Fougera Investigational Site	Coral Gables	Florida
United States	Fougera Investigational Site	Hazleton	Pennsylvania
United States	Fougera Investigational Site	Henderson	Nevada
United States	Fougera Investigational Site	Hialeah	Florida
United States	Fougera Investigational Site	High Point	North Carolina
United States	Fougera Investigational Site	Hot Springs	Arkansas
United States	Fougera Investigational Site	Lake Charles	Louisiana
United States	Fougera Investigational Site	Louisville	Kentucky
United States	Fougera Investigational Site	Macon	Georgia
United States	Fougera Investigational Site	Miami	Florida
United States	Fougera Investigational Site	Miami	Florida
United States	Fougera Investigational Site	Miami	Florida
United States	Fougera Investigational Site	Miami Gardens	Florida
United States	Fougera Investigational Site	Miramar	Florida
United States	Fougera Investigational Site	New Albany	Indiana
United States	Fougera Investigational Site	North Hollywood	California
United States	Fougera Investigational Site	Phoenix	Arizona
United States	Fougera Investigational Site	Plainfield	Indiana
United States	Fougera Investigational Site	Saint Joseph	Missouri
United States	Fougera Investigational Site	Salem	Oregon
United States	Fougera Investigational Site	San Antonio	Texas
United States	Fougera Investigational Site	San Diego	California
United States	Fougera Investigational Site	San Ramon	California
United States	Fougera Investigational Site	Sweetwater	Florida
United States	Fougera Investigational Site	Tampa	Florida
United States	Fougera Investigational Site	Upper Saint Clair	Pennsylvania
United States	Fougera Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success Assessed by IGA	Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).	Week 12
Secondary	Disease Severity None or Minimal on IGA	Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).	Week 12
Secondary	Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI	Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).	Week 12