Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris

To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Adapalene Gel, 0.1%; Drug: Tazarotene Cream, 0.1%; Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%

Detailed Description

Same as above.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center-Dept. of Dermatology
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New York
    • Brooklyn, New York, United States, 11203
      • State University of New York Downstate Medical Center-Dept. of Dermatology
  • Ohio
    • Cincinnati, Ohio, United States, 45230
      • Dermatology Research Associates
  • Oregon
    • Portland, Oregon, United States, 97210
      • Phoebe Rich, MD & Associates
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Milton S. Hershey Medical Center Center-Div. of Dermatology
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Bryan, Texas, United States, 77802
      • J & S Studies, Inc.
    • Carrollton, Texas, United States, 75006
      • Stephens & Associates
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
• Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

• Subjects with more than 3 nodulo-cystic lesions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Differin® Gel, 0.1% for 12 weeks	Drug: Adapalene Gel, 0.1%; Apply once daily in the evening for 12 weeks; Other Names: Differin® Gel, 0.1%
Active Comparator: 2; Tazorac® Cream, 0.1% for 12 weeks	Drug: Tazarotene Cream, 0.1%; Apply once daily in the evening for 12 weeks; Other Names: Tazorac® Cream, 0.1%
Active Comparator: 3; Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks	Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%; Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks; Other Names: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy - total lesion counts	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety - tolerability assessments and adverse event reporting	12 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: May 2, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 4, 2007

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Micronutrients; Vitamins; Keratolytic Agents; Vitamin B Complex; Nicotinic Acids; Tazarotene; Adapalene
• Other Study ID Numbers: US10026