A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
Information source: Coria Laboratories, Ltd.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: tretinoin gel 0.05% (Drug); vehicle (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Coria Laboratories, Ltd. Official(s) and/or principal investigator(s):
Morris V Shelanski, MD, Principal Investigator, Affiliation: Unaffiliated
Overall contact:
Marianne Stoudemeyer, Phone: 610-825-4792, Email: skininc3@aol.com
Summary
To compare the efficacy and safety of tretinoin gel 0. 05% to its vehicle when dosed once or
twice daily in female subjects with rosacea.
Clinical Details
Official title: A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea
Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in signs and symptoms of rosacea
Secondary outcome: Changes in various skin parameters
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female
- Age 18-65
- Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea
Exclusion Criteria:
- Male, females less than 18 years
- Females over 65 years
- No diagnosed rosacea
Locations and Contacts
Marianne Stoudemeyer, Phone: 610-825-4792, Email: skininc3@aol.com
Product Investigations, Inc., Conshohocken, Pennsylvania 19428, United States; Recruiting
Tracy Stoudemeyer, Principal Investigator
Additional Information
Starting date: February 2008
Ending date: November 2008
Last updated: March 26, 2008
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