Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne - Full Text View

Purpose

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

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene Gel, 0.1% Drug: Tazarotene Cream, 0.1% Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%	Phase IV

MedlinePlus related topics:

Acne

Drug Information available for:

Tazarotene Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Efficacy - total lesion counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety - tolerability assessments and adverse event reporting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	302
Study Start Date:	February 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Differin® Gel, 0.1% for 12 weeks	Drug: Adapalene Gel, 0.1% Apply once daily in the evening for 12 weeks
2: Active Comparator Tazorac® Cream, 0.1% for 12 weeks	Drug: Tazarotene Cream, 0.1% Apply once daily in the evening for 12 weeks
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% 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

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469755

Locations


United States, California
	Therapeutics Clinical Research
	San Diego, California, United States, 92123

United States, Michigan
	Henry Ford Medical Center-Dept. of Dermatology
	Detroit, Michigan, United States, 48202

United States, Minnesota
	Minnesota Clinical Study Center
	Fridley, Minnesota, United States, 55432

United States, New York
	State University of New York Downstate Medical Center-Dept. of Dermatology
	Brooklyn, New York, United States, 11203

United States, Ohio
	Dermatology Research Associates
	Cincinnati, Ohio, United States, 45230

United States, Oregon
	Phoebe Rich, MD & Associates
	Portland, Oregon, United States, 97210

United States, Pennsylvania
	Milton S. Hershey Medical Center Center-Div. of Dermatology
	Hershey, Pennsylvania, United States, 17033-0850

United States, Texas
	DermResearch, Inc.
	Austin, Texas, United States, 78759
	J & S Studies, Inc.
	Bryan, Texas, United States, 77802
	Stephens & Associates
	Carrollton, Texas, United States, 75006

United States, Utah
	Dermatology Research Center
	Salt Lake City, Utah, United States, 84124

United States, Virginia
	Virginia Clinical Research, Inc.
	Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators


Study Director:	Ronald W Gottschalk, MD	Galderma Laboratories, L.P.

More Information

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10026
First Received:	May 2, 2007
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00469755
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Tazarotene

Exanthema

Facial Dermatoses

Facies

Skin Diseases

Adapalene

Sebaceous Gland Diseases

Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Physiological Effects of Drugs

Pharmacologic Actions

Keratolytic Agents

Acneiform Eruptions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Dermatologic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00469755