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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Tazarotene Cream 0.1%; Drug: Tazorac®; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 1077
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tazarotene Cream 0.1%; Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)	Drug: Tazarotene Cream 0.1%; Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.; Other Names: Tazarotene
Active Comparator: Tazorac®; Tazorac® (tazarotene cream 0.1%) (Allergan LLC)	Drug: Tazorac®; Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.; Other Names: Tazarotene
Placebo Comparator: Placebo; Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)	Drug: Placebo; Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory lesion counts	Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts	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	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 12

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 4, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamins; Keratolytic Agents; Vitamin B Complex; Nicotinic Acids; Tazarotene
• Other Study ID Numbers: TAZC 1308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No