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

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Tazarotene Cream 0.05%; Drug: Placebo; Drug: TAZORAC® (tazarotene) Cream 0.05%

• Registration Number: NCT02886702
• Lead Sponsor: Fougera Pharmaceuticals Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Study Start: 2016-09-19
• Primary Completion: 2017-08-02
• Study Completion: 2017-08-02
• Status Verified: 2018-07
• Results First Submitted: 2018-07-30
• Results First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Results First Posted: 2018-08-29
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Tazarotene Cream 0.05%	Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Placebo	Placebo	Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Reference	TAZORAC® (tazarotene) Cream 0.05%	TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)

Primary Outcome Measures

Name	Time	Method
Treatment Success Assessed by IGA	Week 12	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).

Secondary Outcome Measures

Name	Time	Method
Disease Severity None or Minimal on IGA	Week 12	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).
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI	Week 12	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).

Trial Locations

Locations (1)

Fougera Investigational Site; 🇺🇸 San Antonio, Texas, United States