Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
1 other identifier
interventional
503
2 countries
31
Brief Summary
The study hypothesis are based on the assumption that :
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2013
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 18, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
September 9, 2016
CompletedJune 28, 2018
May 1, 2018
8 months
June 14, 2013
March 7, 2016
May 28, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Success Rate
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Week 12
Changes From Baseline in Inflammatory Lesion Counts
Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts
Baseline - Week 12
Study Arms (3)
CD0271 0.3% /CD1579 2.5% Gel
EXPERIMENTALactive arm
CD0271 0.1% / CD1579 2.5%
ACTIVE COMPARATORComparator arm
Topical Gel Vehicle
PLACEBO COMPARATORPlacebo arm
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, who is 12 years of age or older at Screening visit.
- Clinical diagnosis of acne vulgaris with facial involvement.
- An IGA of Moderate (3) or Severe (4) at Baseline visit.
- A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
- 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.
You may not qualify if:
- More than 2 acne nodules on the face at Baseline visit.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
- 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.
- The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
- The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
- Use of hormonal contraceptives solely for control of acne.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (31)
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
Related Publications (3)
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.
PMID: 28686776DERIVEDAlexis 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.
PMID: 28686775DERIVEDStein 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.
PMID: 26945741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Galderma CPM
- Organization
- Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 18, 2013
Study Start
July 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 28, 2018
Results First Posted
September 9, 2016
Record last verified: 2018-05