Back to resultsTopical Agent for Treatment of Red Skin
Primary Purpose
Rosacea, Bilaterally Symmetric Red Skin on Cheeks
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topical SR-01
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Reduction of redness
Secondary Outcome Measures
Safety and tolerability
Cosmetic acceptability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00279890
Brief Title
Topical Agent for Treatment of Red Skin
Official Title
Proof of Concept Trial:SR-01 for the Treatment of Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
Brief Summary
SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Bilaterally Symmetric Red Skin on Cheeks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topical SR-01
Primary Outcome Measure Information:
Title
Reduction of redness
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
Cosmetic acceptability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark V. Dahl, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
55259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Agent for Treatment of Red Skin
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