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

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1110
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Fougera Investigational Site
  • Arkansas
    • Conway, Arkansas, United States, 72034
      • Fougera Investigational Site
    • Hot Springs, Arkansas, United States, 71913
      • Fougera Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Fougera Investigational Site
    • La Mesa, California, United States, 91942
      • Fougera Investigational Site
    • Long Beach, California, United States, 90806
      • Fougera Investigational Site
    • Long Beach, California, United States, 90813
      • Fougera Investigational Site
    • Los Angeles, California, United States, 90010
      • Fougera Investigational Site
    • North Hollywood, California, United States, 91606
      • Fougera Investigational Site
    • San Diego, California, United States, 92108
      • Fougera Investigational Site
    • San Ramon, California, United States, 94582
      • Fougera Investigational Site
    • Upland, California, United States, 91786
      • Fougera Investigational Site
    • West Covina, California, United States, 91790
      • Fougera Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Fougera Investigational Site
    • Miami, Florida, United States, 33015
      • Fougera Investigational Site
    • Miami, Florida, United States, 33175
      • Fougera Investigational Site
    • Miami Gardens, Florida, United States, 33169
      • Fougera Investigational Site
    • Miramar, Florida, United States, 33027
      • Fougera Investigational Site
    • Sweetwater, Florida, United States, 33172
      • Fougera Investigational Site
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Fougera Investigational Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Fougera Investigational Site
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Fougera Investigational Site
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Fougera Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Fougera Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Fougera Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 38 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.
• 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
Placebo Comparator: Placebo; Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)	Drug: Placebo; Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Other Names: Vehicle
Experimental: Test; Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)	Drug: Tazarotene Cream 0.1%; Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Other Names: Tazarotene
Active Comparator: Reference; TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)	Drug: Tazorac®; Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Other Names: Tazarotene

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: Fougera Pharmaceuticals Inc.
• Investigators: Study Director: Angela C. Kaplan, Fougera Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

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: 0454-01-01; 0454 (Other Identifier: Fougera Pharmaceuticals Inc.)

Plan for Individual participant data (IPD)

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