Back to resultsAssess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole gel 1%
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions
Exclusion Criteria:
- Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis
Sites / Locations
- Colorado Springs Research Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Six replicate Corneometer CM 825 measurements
Secondary Outcome Measures
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436527
Brief Title
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Official Title
MetroGel 1% Hydration Study: A Kinetic Regression Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.
Detailed Description
This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Metronidazole gel 1%
Other Intervention Name(s)
MetroGel® 1%
Intervention Description
Applied once to a test site on the right or left cheek (as determined by a randomization design)
Primary Outcome Measure Information:
Title
Six replicate Corneometer CM 825 measurements
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions
Exclusion Criteria:
Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma Laboratories, LP
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Springs Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
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