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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Tazarotene Cream 0.1%; Drug: Placebo; Drug: Tazorac®

• Registration Number: NCT02886715
• Lead Sponsor: Fougera Pharmaceuticals Inc.

Brief Summary

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

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: 2016-09-21
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Results First Submitted: 2018-05-31
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Results First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Tazarotene Cream 0.1%	Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
Placebo	Placebo	Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Reference	Tazorac®	TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Lesion Counts	Week 12	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in Non-inflammatory Lesion Counts	Week 12	Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary Outcome Measures

Name	Time	Method
Clinical Response of Success	Week 12	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

Trial Locations

Locations (1)

Fougera Investigational Site; 🇺🇸 Austin, Texas, United States