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

NCT00469755 | Completed Phase 4

• 1 other identifier: US10026
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Efficacy - total lesion counts

  12 weeks

Secondary Outcomes (1)

• Safety - tolerability assessments and adverse event reporting

  12 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Differin® Gel, 0.1% for 12 weeks

Drug: Adapalene Gel, 0.1%

2

ACTIVE COMPARATOR

Tazorac® Cream, 0.1% for 12 weeks

Drug: Tazarotene Cream, 0.1%

3

ACTIVE COMPARATOR

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%

Interventions

Adapalene Gel, 0.1% DRUG

Apply once daily in the evening for 12 weeks

Also known as: Differin® Gel, 0.1%

1

Tazarotene Cream, 0.1% DRUG

Apply once daily in the evening for 12 weeks

Also known as: Tazorac® Cream, 0.1%

2

Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% DRUG

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

Also known as: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

3

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects with more than 3 nodulo-cystic lesions

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (12)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Henry Ford Medical Center-Dept. of Dermatology

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

State University of New York Downstate Medical Center-Dept. of Dermatology

Brooklyn, New York, 11203, United States

Location

Dermatology Research Associates

Cincinnati, Ohio, 45230, United States

Location

Phoebe Rich, MD & Associates

Portland, Oregon, 97210, United States

Location

Milton S. Hershey Medical Center Center-Div. of Dermatology

Hershey, Pennsylvania, 17033-0850, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

Bryan, Texas, 77802, United States

Location

Stephens & Associates

Carrollton, Texas, 75006, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: February 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 29, 2022

Record last verified: 2008-03

Locations

US (12)