Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Stiefel Laboratories |
---|---|
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 |
---|---|---|
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 |
---|---|
1: Experimental
Benzoyl peroxide/clindamycin gel + tazarotene cream
|
Drug: Benzoyl peroxide/clindamycin gel + tazarotene cream
clindamycin phosphate, benzoyl peroxide,and/or tazarotene cream applied topically once a day for 12 weeks
|
2: Active Comparator
Benzoyl peroxide/clindamycin gel + vehicle cream
|
Drug: Benzoyl peroxide/clindamycin gel + vehicle cream
clindamycin phosphate, benzoyl peroxide, vehicle cream applied topically once a day for 12 weeks
|
3: Active Comparator
Benzoyl peroxide gel + tazarotene cream
|
Drug: Benzoyl peroxide gel + tazarotene cream
benzoyl peroxide, tazarotene cream applied topically once a day for 12 weeks
|
4: Active Comparator
Clindamycin gel + tazarotene cream
|
Drug: Clindamycin gel + tazarotene cream
clindamycin gel and tazarotene cream applied topically once a day for 12 weeks
|
5: Active Comparator
Vehicle gel+ tazarotene cream
|
Drug: Vehicle gel+ tazarotene cream
Vehicle gel and tazarotene cream applied topically once a day for 12 weeks
|
6: Placebo Comparator
Vehicle gel + vehicle cream
|
Drug: Vehicle gel + vehicle cream
Vehicle gel and vehicle cream applied topically once a day for 12 weeks
|
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 | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Betty Davis 501-227-8422 ext 21 | |
Principal Investigator: Scott Dinehart, MD | |
United States, California | |
Center for Dermatology Cosmetic and Laser Surgery | Recruiting |
Fremont, California, United States, 94538 | |
Contact: Cindy Epps 510-797-4111 ext 216 | |
Principal Investigator: Sunil Dhawan, MD | |
Center for Dermatology and Laser Surgery | Recruiting |
Sacramento, California, United States, 95819 | |
Contact: Regan Johnson 916-454-5922 | |
Principal Investigator: Emil Tanghetti, MD | |
United States, Colorado | |
Boulder Medical Center, P.C. | Recruiting |
Boulder, Colorado, United States, 80304 | |
Contact: Rindy Dahlen 303-440-3046 | |
Principal Investigator: Steven Hong, MD | |
United States, Florida | |
Dermatology Associates Research | Recruiting |
Coral Gables, Florida, United States, 33134 | |
Contact: Luz Marin 305-567-1930 | |
Principal Investigator: David Rodriquez, MD | |
United States, Georgia | |
MedaPhase, Inc. | Recruiting |
Newnan, Georgia, United States, 30263 | |
Contact: Karen Mangieri 770-252-6900 | |
Principal Investigator: Mark Ling, MD | |
United States, Maryland | |
Callender Center for Clinical Research | Recruiting |
Mitchellville, Maryland, United States, 20721 | |
Contact: Kymberly Valentine 301-249-0970 | |
Principal Investigator: Valerie Callender, MD | |
United States, Michigan | |
Grekin Skin Institute | Recruiting |
Warren, Michigan, United States, 48088 | |
Contact: Jennifer Meitzner 586-759-5525 | |
Principal Investigator: Steve Grekin, MD | |
United States, North Carolina | |
Dermatology Consulting Services | Recruiting |
High Point, North Carolina, United States, 27262 | |
Contact: Tina Hatch, CCRC 336-841-1411 | |
Principal Investigator: Zoe Draelos, MD | |
University of North Carolina Chapel Hill | Not yet recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Erika Hanami 919-843-5126 erika_hanami@med.unc.edu | |
Principal Investigator: Aida Lugo, MD | |
United States, Pennsylvania | |
MS Hershey Medical Center | Not yet recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Silvia Gosik 717-531-1513 sgosik@psu.edu | |
Principal Investigator: Andrea Zaenglein, MD | |
United States, Tennessee | |
The Skin Wellness Center, PC | Recruiting |
Knoxville, Tennessee, United States, 37922 | |
Contact: Kim Gateman, LPN 865-251-9963 | |
Principal Investigator: Kimberly Grande, MD | |
Rivergate Dermatology & Skin Care Center | Recruiting |
Goodlettsville, Tennessee, United States, 37072 | |
Contact: Peggy Washer 615-859-0900 | |
Principal Investigator: Keith Loven, MD | |
United States, Texas | |
Dermatology Treatment & Research Center | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Charles Kundig 972-661-2729 ext 229 | |
Principal Investigator: William Abramovits, MD | |
Suzanne Bruce and Associates, PA | Recruiting |
Houston, Texas, United States, 77056 | |
Contact: Sandy Nero 713-850-0240 ext 112 | |
Principal Investigator: Suzanne Bruce, MD | |
Dermatology Clinical Research Center of San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Glennda Bruce 210-692-1382 | |
Principal Investigator: Steven A. Davis, MD |
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: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00713609 |
Health Authority: | United States: Food and Drug Administration |
Acne Vulgaris Acne Pimples |
Tazarotene Exanthema Clindamycin Facial Dermatoses Clindamycin-2-phosphate |
Facies Skin Diseases Benzoyl Peroxide Sebaceous Gland Diseases Acne Vulgaris |
Keratolytic Agents Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Acneiform Eruptions Therapeutic Uses Enzyme Inhibitors Dermatologic Agents Pharmacologic Actions |