Status:
COMPLETED
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 subgro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT01880320
Start Date
July 1 2013
End Date
March 1 2014
Last Update
June 28 2018
Active Locations (31)
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1
Galderma Investigational site
Birmingham, Alabama, United States
2
Galderma Investigationnal Site
Mobile, Alabama, United States
3
Galderma investigational Site
Hot Springs, Arkansas, United States
4
Galderma Investigational Site
Los Angeles, California, United States