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

NCT02886702 | Completed Phase 3 Results

• 2 other identifiers: 0453-01-010453
• Study Type: interventional
• Target: 855
• Locations: 1 country
• Sites: 30

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disease Severity None or Minimal on IGA

  Week 12

• Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI

  Week 12

Study Arms (3)

Test

EXPERIMENTAL

Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)

Drug: Tazarotene Cream 0.05%

Reference

ACTIVE COMPARATOR

TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)

Drug: TAZORAC® (tazarotene) Cream 0.05%

Placebo

PLACEBO COMPARATOR

Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Drug: Placebo

Interventions

Tazarotene Cream 0.05% DRUG

Tazarotene Cream 0.05% to cover only the lesions with a thin film.

Also known as: Tazarotene

Test

TAZORAC® (tazarotene) Cream 0.05% DRUG

TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.

Also known as: Tazarotene

Reference

Placebo DRUG

Placebo (vehicle of the test product) to cover only the lesions with a thin film.

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fougera Pharmaceuticals Inc.: lead

Study Sites (30)

Fougera Investigational Site

Phoenix, Arizona, 85018, United States

Location

Fougera Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Fougera Investigational Site

Anaheim, California, 92801, United States

Location

Fougera Investigational Site

North Hollywood, California, 91606, United States

Location

Fougera Investigational Site

San Diego, California, 92108, United States

Location

Fougera Investigational Site

San Ramon, California, 94582, United States

Location

Fougera Investigational Site

Brandon, Florida, 33511, United States

Location

Fougera Investigational Site

Coral Gables, Florida, 33134, United States

Location

Fougera Investigational Site

Hialeah, Florida, 33016, United States

Location

Fougera Investigational Site

Miami, Florida, 33015, United States

Location

Fougera Investigational Site

Miami, Florida, 33143, United States

Location

Fougera Investigational Site

Miami, Florida, 33175, United States

Location

Fougera Investigational Site

Miami Gardens, Florida, 33169, United States

Location

Fougera Investigational Site

Miramar, Florida, 33027, United States

Location

Fougera Investigational Site

Sweetwater, Florida, 33172, United States

Location

Fougera Investigational Site

Tampa, Florida, 33618, United States

Location

Fougera Investigational Site

West Palm Beach, Florida, 33406, United States

Location

Fougera Investigational Site

Macon, Georgia, 31217, United States

Location

Fougera Investigational Site

Arlington Heights, Illinois, 60005, United States

Location

Fougera Investigational Site

New Albany, Indiana, 47150, United States

Location

Fougera Investigational Site

Plainfield, Indiana, 46168, United States

Location

Fougera Investigational Site

Louisville, Kentucky, 40202, United States

Location

Fougera Investigational Site

Lake Charles, Louisiana, 70605, United States

Location

Fougera Investigational Site

Saint Joseph, Missouri, 91606, United States

Location

Fougera Investigational Site

Henderson, Nevada, 89052, United States

Location

Fougera Investigational Site

High Point, North Carolina, 27262, United States

Location

Fougera Investigational Site

Salem, Oregon, 97302, United States

Location

Fougera Investigational Site

Hazleton, Pennsylvania, 18201, United States

Location

Fougera Investigational Site

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Fougera Investigational Site

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Interventions

tazarotene

Results Point of Contact

• Title: Angela C Kaplan
• Organization: Fougera Pharmaceuticals Inc.

angela.kaplan@sandoz.com

631-659-2256

Study Officials

• Angela C. Kaplan

  Fougera Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: September 19, 2016
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)