NCT Number: NCT01880320
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
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
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Notify MeKey information
Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Galderma Investigational Site, Barrie, Canada
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
CD0271 0.1% / CD1579 2.5%
DrugTopical Gel Vehicle
DrugPrimary outcomes
-
Success Rate
Time frame: Week 12
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.
-
Changes From Baseline in Inflammatory Lesion Counts
Time frame: Baseline - Week12
-
Changes From Baseline in Non-Inflammatory Lesion Counts
Time frame: Baseline - Week 12
Sponsors and collaborators
Lead sponsor
Galderma R&D
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 18, 2013
- Registry last updated
- Jun 28, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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