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NCT00279890 Clinical Trial

Topical Agent for Treatment of Red Skin

Rosacea Clinical Trial

Official title:
Proof of Concept Trial:SR-01 for the Treatment of Rosacea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00279890
Other study ID # 44-05
Secondary ID MCS 385
Status Completed
Phase Phase 1
First received January 18, 2006
Last updated May 20, 2011
Start date July 2005
Est. completion date January 2007

Study information
Verified date May 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Bilaterally Symmetric Red Skin on Cheeks
  • Rosacea

Intervention

Drug:
• Topical SR-01

Locations
Country Name City State
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of redness
Secondary Safety and tolerability
Secondary Cosmetic acceptability
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