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

NCT02886715 | Completed Phase 3 Results

• 2 other identifiers: 0454-01-010454
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 25

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Response of Success

  Week 12

Study Arms (3)

Test

EXPERIMENTAL

Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)

Drug: Tazarotene Cream 0.1%

Reference

ACTIVE COMPARATOR

TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)

Drug: Tazorac®

Placebo

PLACEBO COMPARATOR

Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Drug: Placebo

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.

Also known as: Tazarotene

Test

Tazorac® DRUG

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

Also known as: Tazarotene

Reference

Placebo DRUG

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

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fougera Pharmaceuticals Inc.: lead

Study Sites (25)

Fougera Investigational Site

Tucson, Arizona, 85712, United States

Location

Fougera Investigational Site

Conway, Arkansas, 72034, United States

Location

Fougera Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Fougera Investigational Site

Anaheim, California, 92801, United States

Location

Fougera Investigational Site

La Mesa, California, 91942, United States

Location

Fougera Investigational Site

Long Beach, California, 90806, United States

Location

Fougera Investigational Site

Long Beach, California, 90813, United States

Location

Fougera Investigational Site

Los Angeles, California, 90010, United States

Location

Fougera Investigational Site

North Hollywood, California, 91606, United States

Location

Fougera Investigational Site

San Diego, California, 92108, United States

Location

Fougera Investigational Site

San Ramon, California, 94582, United States

Location

Fougera Investigational Site

Upland, California, 91786, United States

Location

Fougera Investigational Site

West Covina, California, 91790, United States

Location

Fougera Investigational Site

Coral Gables, Florida, 33134, United States

Location

Fougera Investigational Site

Miami, Florida, 33015, United States

Location

Fougera Investigational Site

Miami, Florida, 33175, United States

Location

Fougera Investigational Site

Miami Gardens, Florida, 33169, United States

Location

Fougera Investigational Site

Miramar, Florida, 33027, United States

Location

Fougera Investigational Site

Sweetwater, Florida, 33172, United States

Location

Fougera Investigational Site

Plainfield, Indiana, 46168, United States

Location

Fougera Investigational Site

High Point, North Carolina, 27262, United States

Location

Fougera Investigational Site

Hazleton, Pennsylvania, 18201, United States

Location

Fougera Investigational Site

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Fougera Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

Fougera Investigational Site

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Angela C Kaplan
• Organization: Fougera Pharmaceuticals Inc.

angela.kaplan@sandoz.com

631-659-2256

Study Officials

• Angela C. Kaplan

  Fougera Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: September 21, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: August 17, 2018
• Results First Posted: August 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)