Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne - Full Text View

Sponsored by:	Stiefel, a GSK Company
Information provided by:	Stiefel, a GSK Company
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

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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Benzoyl peroxide Tazarotene

U.S. FDA Resources

Further study details as provided by Stiefel, a GSK Company:

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
Study Completion Date:	March 2009
Primary Completion Date:	March 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
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

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

David G Angulo, MD

Sr. Director Global Clinical Research, Stiefel Laboratories, Inc.

More Information

No publications provided

Responsible Party:	Stiefel Laboratories, Inc. ( Jason Mann / Director Global Clinical Operations )
Study ID Numbers:	W0259-201
Study First Received:	July 7, 2008
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00713609 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stiefel, a GSK Company:

Acne Vulgaris
Acne
Pimples

Study placed in the following topic categories:

Tazarotene
Anti-Infective Agents
Clindamycin
Facial Dermatoses
Skin Diseases
Facies
Clindamycin-2-phosphate

Benzoyl Peroxide
Sebaceous Gland Diseases
Acne Vulgaris
Keratolytic Agents
Exanthema
Anti-Bacterial Agents

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 03, 2009