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 Inc.1,110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,110

Conditions

Acne Vulgaris

Interventions

Tazarotene Cream 0.1%DRUG

Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Tazorac®DRUG

Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.

PlaceboDRUG

Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (25)

Fougera Investigational Site

Outcomes

Primary Outcomes

Change in Inflammatory Lesion Counts

Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

Time frame: Week 12

Change in Non-inflammatory Lesion Counts

Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Time frame: Week 12

Secondary Outcomes

Clinical Response of Success

The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

Time frame: Week 12

Data from ClinicalTrials.gov

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