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

Phase 1

Completed

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

• Registration Number: NCT02411955
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).

Detailed Description

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Study First Submitted: 2015-04-04
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1077

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
• 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
Tazarotene Cream 0.1%	Tazarotene Cream 0.1%	Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
Tazorac®	Tazorac®	Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
Placebo	Placebo	Placebo (Vehicle of the test product) (Taro Pharmaceuticals 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