Clinical trial NCT00713609: Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne
Acne Vulgaris
Pimples
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-11
Enrollment: 591
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
timeFrame: Baseline and up to Week 12
measure: Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
timeFrame: Baseline and up to Week 12
Secondary outcomes:
measure: Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
timeFrame: Baseline and up to Week 12
measure: Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Cosmetic and Laser Surgery
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Boulder
country: United States
facility: Boulder Medical Center, P.C.
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Associates Research
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Mitchellville
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Hershey
country: United States
facility: MS Hershey Medical Center
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Rivergate Dermatology & Skin Care Center
state: Tennessee
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: