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| Sponsor: | Stiefel, a GSK Company |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01017120 |
Purpose
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Tazarotene Foam Drug: Vehicle Foam |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris |
| Enrollment: | 742 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tazarotene foam, 0.1%
|
Drug: Tazarotene Foam
Tazarotene foam once a day application to the face
|
|
Placebo Comparator: 2
Vehicle Foam
|
Drug: Vehicle Foam
Vehicle Foam once a day application to the face
|
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Lesion counts meeting both of the following criteria:
Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
Exclusion Criteria:
Contacts and Locations| United States, California | |
| The Laser Institute for Dermatology | |
| Santa Monica, California, United States, 90404 | |
| United States, Florida | |
| FXM Research Corporation | |
| Miami, Florida, United States, 33175 | |
| United States, Georgia | |
| Atlanta Dermatology & Vein Research Center, PC | |
| Alpharetta, Georgia, United States, 30022 | |
| Gwinnett Clinical Research Center, Inc. | |
| Snellville, Georgia, United States, 30078 | |
| United States, Indiana | |
| Hudson Dermatology | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Dermatology Specialists | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| Somerset Skin Centre | |
| Troy, Michigan, United States, 48084 | |
| United States, Nebraska | |
| Skin Specialists, P.C. | |
| Omaha, Nebraska, United States, 68144 | |
| United States, New York | |
| Dermatology Associates of Rochester, PC | |
| Rochester, New York, United States, 14623 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Texas | |
| Suzanne Bruce and Associates, PA | |
| Houston, Texas, United States, 77056 | |
| Progressive Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Virginia Clinical Research, Inc. | |
| Norfolk, Virginia, United States, 23507 | |
| Canada, British Columbia | |
| Guildford Dermatology Specialist | |
| Surrey, British Columbia, Canada, V3R 6A7 | |
| Canada, Manitoba | |
| Dermadvances Research | |
| Winnipeg, Manitoba, Canada, R3C 1R4 | |
| Canada, Ontario | |
| Lynderm Research, Inc. | |
| Markham, Ontario, Canada, L3P 1A8 | |
| North Bay Dermatology Centre | |
| North Bay, Ontario, Canada, P1B3Z7 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01017120 History of Changes |
| Other Study ID Numbers: | 114576, W0260-302 |
| Study First Received: | November 19, 2009 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Acne |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
Tazarotene Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions |