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Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
This study is currently recruiting participants.
Verified by Stiefel Laboratories, September 2008
Sponsored by: Stiefel Laboratories
Information provided by: Stiefel Laboratories
ClinicalTrials.gov Identifier: NCT00713609
  Purpose

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

MedlinePlus related topics: Acne
Drug Information available for: Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate Tazarotene
U.S. FDA Resources
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

Further study details as provided by Stiefel Laboratories:

Primary Outcome Measures:
  • The absolute change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have a minimum 2-grade improvement in ISGA score from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent (%) change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have an ISGA score of 0 or 1 at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
  • Subjects must have acne on their face.
  • Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
  • Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
  • Subjects must be able to complete the study and to comply with study instructions.

Exclusion Criteria:

  • Subjects who are pregnant, trying to become pregnant, or breast-feeding.
  • Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
  • History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
  • Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
  • Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
  • Other exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713609

Locations
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            
Sponsors and Collaborators
Stiefel Laboratories
Investigators
Study Director: David G Angulo, MD Sr. Director Global Clinical Research, Stiefel Laboratories, Inc.
  More Information

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

Keywords provided by Stiefel Laboratories:
Acne Vulgaris
Acne
Pimples

Study placed in the following topic categories:
Tazarotene
Exanthema
Clindamycin
Facial Dermatoses
Clindamycin-2-phosphate
Facies
Skin Diseases
Benzoyl Peroxide
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009