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
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