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Sponsored by: |
Stiefel Laboratories |
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Information provided by: | Stiefel Laboratories |
ClinicalTrials.gov Identifier: | NCT00713609 |
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: Benzoyl peroxide/clindamycin gel + tazarotene cream Drug: Benzoyl peroxide/clindamycin gel + vehicle cream Drug: Benzoyl peroxide gel + tazarotene cream Drug: Clindamycin gel + tazarotene cream Drug: Vehicle gel+ tazarotene cream Drug: Vehicle gel + vehicle cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris |
Estimated Enrollment: | 600 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Benzoyl peroxide/clindamycin gel + tazarotene cream
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Drug: Benzoyl peroxide/clindamycin gel + tazarotene cream
clindamycin phosphate, benzoyl peroxide,and/or tazarotene cream applied topically once a day for 12 weeks
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2: Active Comparator
Benzoyl peroxide/clindamycin gel + vehicle cream
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Drug: Benzoyl peroxide/clindamycin gel + vehicle cream
clindamycin phosphate, benzoyl peroxide, vehicle cream applied topically once a day for 12 weeks
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3: Active Comparator
Benzoyl peroxide gel + tazarotene cream
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Drug: Benzoyl peroxide gel + tazarotene cream
benzoyl peroxide, tazarotene cream applied topically once a day for 12 weeks
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4: Active Comparator
Clindamycin gel + tazarotene cream
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Drug: Clindamycin gel + tazarotene cream
clindamycin gel and tazarotene cream applied topically once a day for 12 weeks
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5: Active Comparator
Vehicle gel+ tazarotene cream
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Drug: Vehicle gel+ tazarotene cream
Vehicle gel and tazarotene cream applied topically once a day for 12 weeks
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6: Placebo Comparator
Vehicle gel + vehicle cream
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Drug: Vehicle gel + vehicle cream
Vehicle gel and vehicle cream applied topically once a day for 12 weeks
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The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.
Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.
Ages Eligible for Study: | 12 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Dermatology Research of Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Center for Dermatology Cosmetic and Laser Surgery | |
Fremont, California, United States, 94538 | |
Center for Dermatology and Laser Surgery | |
Sacramento, California, United States, 95819 | |
United States, Colorado | |
Boulder Medical Center, P.C. | |
Boulder, Colorado, United States, 80304 | |
United States, Florida | |
Dermatology Associates Research | |
Coral Gables, Florida, United States, 33134 | |
United States, Georgia | |
MedaPhase, Inc. | |
Newnan, Georgia, United States, 30263 | |
United States, Maryland | |
Callender Center for Clinical Research | |
Mitchellville, Maryland, United States, 20721 | |
United States, Michigan | |
Grekin Skin Institute | |
Warren, Michigan, United States, 48088 | |
United States, North Carolina | |
Dermatology Consulting Services | |
High Point, North Carolina, United States, 27262 | |
University of North Carolina Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Pennsylvania | |
MS Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Tennessee | |
The Skin Wellness Center, PC | |
Knoxville, Tennessee, United States, 37922 | |
Rivergate Dermatology & Skin Care Center | |
Goodlettsville, Tennessee, United States, 37072 | |
United States, Texas | |
Dermatology Treatment & Research Center | |
Dallas, Texas, United States, 75230 | |
Suzanne Bruce and Associates, PA | |
Houston, Texas, United States, 77056 | |
Dermatology Clinical Research Center of San Antonio | |
San Antonio, Texas, United States, 78229 |
Study Director: | David G Angulo, MD | Sr. Director Global Clinical Research, Stiefel Laboratories, Inc. |
Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann / Director Global Clinical Operations ) |
Study ID Numbers: | W0259-201 |
Study First Received: | July 7, 2008 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00713609 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acne Vulgaris Acne Pimples |
Keratolytic Agents Tazarotene Anti-Bacterial Agents Exanthema Clindamycin Facial Dermatoses |
Clindamycin-2-phosphate Facies Skin Diseases Benzoyl Peroxide Sebaceous Gland Diseases Acne Vulgaris |
Tazarotene Anti-Infective Agents Clindamycin Facial Dermatoses Molecular Mechanisms of Pharmacological Action Skin Diseases Clindamycin-2-phosphate Benzoyl Peroxide Enzyme Inhibitors |
Sebaceous Gland Diseases Acne Vulgaris Pharmacologic Actions Keratolytic Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Acneiform Eruptions Therapeutic Uses Dermatologic Agents |