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Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: 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 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Stiefel, a GSK Company

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Dermatology Research of Arkansas, Little Rock, Arkansas 72205, United States

Center for Dermatology Cosmetic and Laser Surgery, Fremont, California 94538, United States

Center for Dermatology and Laser Surgery, Sacramento, California 95819, United States

Boulder Medical Center, P.C., Boulder, Colorado 80304, United States

Dermatology Associates Research, Coral Gables, Florida 33134, United States

MedaPhase, Inc., Newnan, Georgia 30263, United States

Callender Center for Clinical Research, Mitchellville, Maryland 20721, United States

Grekin Skin Institute, Warren, Michigan 48088, United States

University of North Carolina Chapel Hill, Chapel Hill, North Carolina 27599, United States

Dermatology Consulting Services, High Point, North Carolina 27262, United States

MS Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Rivergate Dermatology & Skin Care Center, Goodlettsville, Tennessee 37072, United States

The Skin Wellness Center, PC, Knoxville, Tennessee 37922, United States

Dermatology Treatment & Research Center, Dallas, Texas 75230, United States

Suzanne Bruce and Associates, PA, Houston, Texas 77056, United States

Dermatology Clinical Research Center of San Antonio, San Antonio, Texas 78229, United States

Additional Information

Starting date: June 2008
Last updated: February 23, 2012

Page last updated: August 23, 2015

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