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Sponsored by: |
Coria Laboratories, Ltd. |
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Information provided by: | Coria Laboratories, Ltd. |
ClinicalTrials.gov Identifier: | NCT00621218 |
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.
Condition | Intervention | Phase |
---|---|---|
Rosacea |
Drug: tretinoin gel 0.05% Drug: vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 36 |
Study Start Date: | February 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: tretinoin gel 0.05%
Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
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2: Placebo Comparator |
Drug: vehicle
Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Product Investigations, Inc. | |
Conshohocken, Pennsylvania, United States, 19428 |
Principal Investigator: | Morris V Shelanski, MD | Unaffiliated |
Responsible Party: | Coria Laboratories, Ltd. ( D. Innes Cargill, PhD ) |
Study ID Numbers: | 9320-010-002 |
Study First Received: | February 12, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00621218 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
tretinoin, efficacy, safety, rosacea |
Keratolytic Agents Rosacea Skin Diseases Tretinoin |
Keratolytic Agents Rosacea Skin Diseases Antineoplastic Agents |
Therapeutic Uses Tretinoin Dermatologic Agents Pharmacologic Actions |