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Sponsored by: |
Galderma Laboratories, L.P. |
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Information provided by: | Galderma Laboratories, L.P. |
ClinicalTrials.gov Identifier: | NCT00469755 |
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 |
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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: | 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 |
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 |
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1: Active Comparator
Differin® Gel, 0.1% for 12 weeks
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Drug: Adapalene Gel, 0.1%
Apply once daily in the evening for 12 weeks
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2: Active Comparator
Tazorac® Cream, 0.1% for 12 weeks
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Drug: Tazarotene Cream, 0.1%
Apply once daily in the evening for 12 weeks
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3: Active Comparator
Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks
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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
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Same as above.
Ages Eligible for Study: | 12 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, L.P. |
Responsible Party: | Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director ) |
Study ID Numbers: | US10026 |
Study First Received: | May 2, 2007 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00469755 |
Health Authority: | United States: Institutional Review Board |
Tazarotene Exanthema Facial Dermatoses Facies |
Skin Diseases Adapalene Sebaceous Gland Diseases Acne Vulgaris |
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 |