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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Adapalene Tazarotene

U.S. FDA Resources

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
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 Name: 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 Name: 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 Name: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%

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

No publications provided

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

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Tazarotene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on February 12, 2012