Clinical trial NCT00776919: Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Rho, Inc.
name: Quintiles, Inc.
name: GlaxoSmithKline
First posted: 2008-10-22
Enrollment: 1315
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: This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Detailed description: A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Eligibility criteria: Inclusion Criteria:

* Be 12 to 45 years of age, inclusive, and in good general health.
* Clinical diagnosis of acne vulgaris
* Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
* Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
* Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Exclusion Criteria:

* Are pregnant or breast-feeding.
* Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
* Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
* Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
* Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
* Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
* Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
* Used abradents or facial procedures, within the past 2 weeks.
* Use medications that may exacerbate acne.
* Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
* Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Primary outcomes:
measure: Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline to Week 12 in Total Lesion Counts
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
timeFrame: Baseline (Day 1) and Week 12
measure: Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
timeFrame: Week 12
measure: Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline to Week 12 in Temperature
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline to Week 12 in Pulse Rate
timeFrame: Baseline (Day 1) and Week 12
measure: Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Mean Duration of Study Product Use
timeFrame: Baseline (Day 1) through Week 12
measure: Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
timeFrame: Baseline (Day 1) through Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
state: California
city: Santa Monica
country: United States
facility: The Laser Institute for Dermatology
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Miami Beach
country: United States
facility: University of Miami Cosmetic Medicine and Research Institute
state: Florida
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology & Vein Research Center, LLC
state: Georgia
city: Lincolnshire
country: United States
facility: SKINQRI
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Belize City
country: Belize
facility: Dermatology and Skin Care Center FXM Research International
city: Belize City
country: Belize
facility: Dr. Moguel's Clinic/FXM Research International
city: Surrey
country: Canada
facility: Guildford Dermatology Specialist
state: British Columbia
city: Hamilton
country: Canada
facility: Dermatrial Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research, Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Quebec
country: Canada
facility: CRDQ Centre de Recherche Dermatologique du Quebec
city: St. John's
country: Canada
facility: Nexus Clinical Research
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.