Back to resultsA Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Primary Purpose
Acne
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CD0271 0.1%/CD1579 2.5% gel
CD0271 0.1%/CD1579 2.5% gel vehicle
Sponsored by
About this trial
This is an interventional basic science trial for Acne
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged 18 to 35 years inclusive
- Subjects with active, moderate acne
Exclusion Criteria:
- The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
- The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)
Sites / Locations
- Galderma Investigational site
- Galderma Investigational site
- Galderma Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CD0271 0.1%/CD1579 2.5% gel
CD0271 0.1%/CD1579 2.5% gel vehicle
Arm Description
Split-face design, one application a day for 6 months
Split-face design, one application a day for 6 months
Outcomes
Primary Outcome Measures
Description and documentation of acne lesions
Secondary Outcome Measures
Treatment effect on acne lesions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01688531
Brief Title
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Official Title
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Exploratory, international, multi-centre, randomized, investigator blinded study in acne
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD0271 0.1%/CD1579 2.5% gel
Arm Type
Experimental
Arm Description
Split-face design, one application a day for 6 months
Arm Title
CD0271 0.1%/CD1579 2.5% gel vehicle
Arm Type
Placebo Comparator
Arm Description
Split-face design, one application a day for 6 months
Intervention Type
Drug
Intervention Name(s)
CD0271 0.1%/CD1579 2.5% gel
Intervention Description
one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
Intervention Type
Drug
Intervention Name(s)
CD0271 0.1%/CD1579 2.5% gel vehicle
Intervention Description
one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
Primary Outcome Measure Information:
Title
Description and documentation of acne lesions
Time Frame
over 6 months
Secondary Outcome Measure Information:
Title
Treatment effect on acne lesions
Time Frame
over 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged 18 to 35 years inclusive
Subjects with active, moderate acne
Exclusion Criteria:
The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)
Facility Information:
Facility Name
Galderma Investigational site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Galderma Investigational site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Galderma Investigational site
City
Nantes
Country
France
12. IPD Sharing Statement
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A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
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