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NCT00621218 Clinical Trial

A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621218
Other study ID # 9320-010-002
Secondary ID
Status Completed
Phase Phase 2
First received February 12, 2008
Last updated December 17, 2008
Start date February 2008
Est. completion date December 2008

Study information
Verified date December 2008
Source Coria Laboratories, Ltd.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tretinoin gel 0.05%
Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
• vehicle
Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.

Locations
Country Name City State
United States Product Investigations, Inc. Conshohocken Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Coria Laboratories, Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in signs and symptoms of rosacea 16 weeks Yes
Secondary Changes in various skin parameters 16 weeks Yes
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