A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Fougera Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: Tazarotene Cream 0.1%; Drug: Tazorac®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02886715

0454 (Other Identifier)

0454-01-01

Details and patient eligibility

About

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Enrollment: 1,110 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion criteria

• Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,110 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)

Treatment:

Drug: Tazarotene Cream 0.1%

Reference

Active Comparator group

Description:

TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)

Treatment:

Drug: Tazorac®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo