Last updated: 11/07/2018 08:08:34
Trial of clindamycin / benzoyl peroxide gel in Subjects with Acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Mean change from Baseline (BL) to Week 12 in inflammatory lesion counts
Timeframe: Baseline (Day 1) and Week 12
Mean change from Baseline to Week 12 in non-inflammatory lesion counts
Timeframe: Baseline (Day 1) and Week 12
Mean change from Baseline to Week 12 in total lesion counts
Timeframe: Baseline (Day 1) and Week 12
Secondary outcomes:
Mean percent change from Baseline to Week 12 in lesion counts (total, inflammatory, and non-inflammatory)
Timeframe: Baseline (Day 1) and Week 12
Number of participants who had a Subject Global Assessment (SGA) score of 0 or 1 at Week 12
Timeframe: Week 12
Number of participants who had an ISGA score of 0 or 1 at Week 12
Timeframe: Week 12
Mean change from Baseline to Week 12 in systolic and diastolic blood pressure
Timeframe: Baseline (Day 1) and Week 12
Mean change from Baseline to Week 12 in temperature
Timeframe: Baseline (Day 1) and Week 12
Mean change from Baseline to Week 12 in pulse rate
Timeframe: Baseline (Day 1) and Week 12
Mean change from Baseline to Weeks 2, 4, 8, and 12 in erythema, dryness, and peeling
Timeframe: Baseline; Weeks 2, 4, 8, and 12
Mean change from Baseline to Weeks 2, 4, 8, and 12 in itching and burning/stinging
Timeframe: Baseline; Weeks 2, 4, 8, and 12
Mean duration of study product use
Timeframe: Baseline (Day 1) through Week 12
Number of participants reporting the indicated treatment-emergent adverse events (AEs) resulting in study product discontinuation
Timeframe: Baseline (Day 1) through Week 12
Interventions:
Drug: clindamycin / benzoyl peroxide gel
Drug: clindamycin gel
Drug: BPO gel
Drug: vehicle gel
Enrollment:
1315
Observational study model:
Not applicable
Primary completion date:
2009-24-09
Time perspective:
Not applicable
Clinical publications:
Lawrence F. Eichenfield and Alessandra Alio Saenz. Safety and efficacy of clindamycin 1%-benzoyl peroxide 3% fixed dose combination gel for the treatment of acne vulgaris: A phase III, multicenter, randomized, double-blind, parallel group, vehicle-controlled study. [Journal of Drugs in Dermatology]. 2011;10(12):1382-1396.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
RHO CRO, Quintiles CRO, GSK
Study date(s)
October 2008 to September 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 45 years
Accepts healthy volunteers
No
- Be 12 to 45 years of age, inclusive, and in good general health.
- Clinical diagnosis of acne vulgaris
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
Dr. Moguel's Clinic/FXM Research International
Belize City, Belize
Status
Study Complete
Location
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
Status
Study Complete
Location
DermResearch Center of New York
Stony Brook, NY, United States, 11790
Status
Study Complete
Location
CRDQ Centre de Recherche Dermatologique du Quebec
Quebec, Quebec, Canada, G1V 4X7
Status
Study Complete
Location
Dermatology and Skin Care Center FXM Research International
Belize City, Belize
Status
Study Complete
Location
Atlanta Dermatology & Vein Research Center, LLC
Alpharetta, GA, United States, 30022
Status
Study Complete
Location
Progressive Clinical Research
San Antonio, TX, United States, 78229
Status
Study Complete
Location
The Skin Wellness Center, PC
Knoxville, TN, United States, 37922
Status
Study Complete
Location
Dawes Fretzin Clinical Research Group
Indianapolis, IN, United States, 46260
Status
Study Complete
Location
The Laser Institute for Dermatology
Santa Monica, CA, United States, 90404
Status
Study Complete
Location
University of Miami Cosmetic Medicine and Research Institute
Miami Beach, FL, United States, 33140
Status
Study Complete
Location
Dermatology Associates of Rochester, PC
Rochester, NY, United States, 14623
Status
Study Complete
Location
Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
San Diego, CA, United States, 92123
Status
Study Complete
Location
Arlington Center for Dermatology
Arlington, TX, United States, 76011
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-24-09
Actual study completion date
2009-24-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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