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

Phase 2

Completed

• Conditions: Rosacea
• Interventions: Drug: tretinoin gel 0.05%; Drug: vehicle

• Registration Number: NCT00621218
• Lead Sponsor: Coria Laboratories, Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-04
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tretinoin gel 0.05%	-
2	vehicle	-

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of rosacea	16 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in various skin parameters	16 weeks

Trial Locations

Locations (1)

Product Investigations, Inc.; 🇺🇸 Conshohocken, Pennsylvania, United States