Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
NCT ID: NCT01880320
Last Updated: 2018-06-28
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
503 participants
INTERVENTIONAL
2013-07-31
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
* CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
NCT02073461
Study to Investigate the Irritation Potential of GSK1940029 Gel
NCT01984801
Efficacy and Safety of CD5024 1% in Acne Vulgaris
NCT03034460
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
NCT00883233
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
NCT00689117
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CD0271 0.3% /CD1579 2.5% Gel
active arm
CD0271 0.3% / CD1579 2.5%
CD0271 0.1% / CD1579 2.5%
Comparator arm
CD0271 0.1% / CD1579 2.5%
Topical Gel Vehicle
Placebo arm
Topical Gel Vehicle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CD0271 0.3% / CD1579 2.5%
CD0271 0.1% / CD1579 2.5%
Topical Gel Vehicle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical diagnosis of acne vulgaris with facial involvement.
3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.
Exclusion Criteria
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
6. Use of hormonal contraceptives solely for control of acne.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galderma R&D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Galderma Investigational site
Birmingham, Alabama, United States
Galderma Investigationnal Site
Mobile, Alabama, United States
Galderma investigational Site
Hot Springs, Arkansas, United States
Galderma Investigational Site
Los Angeles, California, United States
Galderma Investigational Site
Sacramento, California, United States
Galderma Investigational Site
Santa Monica, California, United States
Galderma Investigational Site
Miami, Florida, United States
Galderma Investigational Site
Miramar, Florida, United States
Galderma Investiogational Site
Newnan, Georgia, United States
Galderma Investigational Site
Snellville, Georgia, United States
Galderma Investigational Site
Chicago, Illinois, United States
Galderma Investigational Site
Detroit, Michigan, United States
Galderma Investigational Site
Albuquerque, New Mexico, United States
Galderma Investigational Site
New York, New York, United States
Galderma Investigational Site
Stony Brook, New York, United States
Galderma Investigational Site
Raleigh, North Carolina, United States
Galderma Investigational Site
Beachwood, Ohio, United States
Galderma investigational Site
Hershey, Pennsylvania, United States
Galderma Investigational Site
Greenville, South Carolina, United States
Galderma Investigational Site
Goodlettsville, Tennessee, United States
Galderma Investigational Site
Knoxville, Tennessee, United States
Galderma Investigational Site
Arlington, Texas, United States
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
Salt Lake City, Utah, United States
Galderma Investigational Site
Spokane, Washington, United States
Galderma Investigational Site
Barrie, , Canada
Galderma Investigational Site
Markham, , Canada
Galderma Investiogational Site
Montreal, , Canada
Galderma Investigational Site
Peterborough, , Canada
Galderma Investigational site
Surrey, , Canada
Galderma Investigational Site
Waterloo, , 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.
Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.
Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.
Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD.06.SPR.18240
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.