- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073461
Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
February 27, 2017 updated by: Galderma R&D
A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
236
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
- Galderma Investigational Site
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Hyogo
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Amagasaki, Hyogo, Japan
- Galderma Investigational Site
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Kobe, Hyogo, Japan
- Galderma Investigational Site
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Tokyo
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Nakano, Tokyo, Japan
- Galderma Investigational Site
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Shibuya, Tokyo, Japan
- Galderma Investigational Site
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Shinjuku, Tokyo, Japan
- Galderma Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women at the age of 12 or older at the Screening visit.
- Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).
Exclusion Criteria:
- Those with more than two nodular acne lesions or any cysts.
- Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
- Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle
|
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Experimental: CD1579 2.5%
Benzoyl Peroxide 2.5%
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Other Names:
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Experimental: CD1579 5%
Benzoyl Peroxide 5%
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Changes From Baseline in Total Lesion Counts
Time Frame: Baseline - Week 12
|
Median percent reductions from Baseline in total lesion count (ITT-LOCF)
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Baseline - Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Tolerability (Erythema)
Time Frame: 12 weeks
|
Highest severity of local tolerability scores worse than Baseline
|
12 weeks
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Local Tolerability (Scaling)
Time Frame: 12 weeks
|
Highest severity of local tolerability scores worse than Baseline
|
12 weeks
|
Local Tolerability (Dryness)
Time Frame: 12 weeks
|
Highest severity of local tolerability scores worse than Baseline
|
12 weeks
|
Local Tolerability (Pruritus)
Time Frame: 12 weeks
|
Highest severity of local tolerability scores worse than Baseline
|
12 weeks
|
Local Tolerability (Stinging/Burning)
Time Frame: 12 weeks
|
Highest severity of local tolerability scores worse than Baseline
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12 weeks
|
Percent of Subjects With Adverse Events
Time Frame: up to 12 weeks
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Adverse events which were observed in 5% or more patients with either group are listed.
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up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 20, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimate)
February 27, 2014
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
February 27, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDT.07.SPR.27124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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