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

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene Gel, 0.1% (Drug); Tazarotene Cream, 0.1% (Drug); Adapalene Gel, 0.1% + Tazarotene Cream, 0.1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

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

Clinical Details

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

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

Primary outcome: Efficacy - total lesion counts

Secondary outcome: Safety - tolerability assessments and adverse event reporting

Detailed description: Same as above.

Eligibility

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

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

Locations and Contacts

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

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

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

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

Dermatology Research Associates, Cincinnati, Ohio 45230, United States

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

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

DermResearch, Inc., Austin, Texas 78759, United States

J & S Studies, Inc., Bryan, Texas 77802, United States

Stephens & Associates, Carrollton, Texas 75006, United States

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

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

Additional Information

Starting date: February 2006
Last updated: March 28, 2008

Page last updated: August 23, 2015

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