Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
NCT ID: NCT00776919
Last Updated: 2016-11-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1315 participants
INTERVENTIONAL
2008-10-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
clindamycin / benzoyl peroxide gel
clindamycin / benzoyl peroxide gel
Once a day application to the face
2
Clindamycin gel
clindamycin gel
Once a day application to the face
3
BPO gel
BPO gel
Once a day application to the face
4
vehicle gel
vehicle gel
Once a day application to the face
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
clindamycin / benzoyl peroxide gel
Once a day application to the face
clindamycin gel
Once a day application to the face
BPO gel
Once a day application to the face
vehicle gel
Once a day application to the face
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
12 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rho, Inc.
INDUSTRY
Quintiles, Inc.
INDUSTRY
GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
San Diego, California, United States
The Laser Institute for Dermatology
Santa Monica, California, United States
Cherry Creek Research, Inc.
Denver, Colorado, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
FXM Research
Miami, Florida, United States
University of Miami Cosmetic Medicine and Research Institute
Miami Beach, Florida, United States
Atlanta Dermatology & Vein Research Center, LLC
Alpharetta, Georgia, United States
SKINQRI
Lincolnshire, Illinois, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Somerset Skin Centre
Troy, Michigan, United States
Dermatology Associates of Rochester, PC
Rochester, New York, United States
DermResearch Center of New York
Stony Brook, New York, United States
The Skin Wellness Center, PC
Knoxville, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology and Skin Care Center FXM Research International
Belize City, , Belize
Dr. Moguel's Clinic/FXM Research International
Belize City, , Belize
Guildford Dermatology Specialist
Surrey, British Columbia, Canada
Dermatrial Research
Hamilton, Ontario, Canada
Lynderm Research, Inc.
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
CRDQ Centre de Recherche Dermatologique du Quebec
Québec, Quebec, Canada
Nexus Clinical Research
St. John's, , Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Informed Consent Form
View DocumentDocument Type: Dataset Specification
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Individual Participant Data Set
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Annotated Case Report Form
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
114677
Identifier Type: -
Identifier Source: org_study_id