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

Fougera Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Tazarotene Cream 0.05%; Drug: TAZORAC® (tazarotene) Cream 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02886702

0453-01-01

0453 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 855 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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855 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)

Treatment:

Drug: Tazarotene Cream 0.05%

Reference

Active Comparator group

Description:

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

Treatment:

Drug: TAZORAC® (tazarotene) Cream 0.05%

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo