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

• Sponsor: Coria Laboratories, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00621218
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: tretinoin gel 0.05%; Drug: vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: tretinoin gel 0.05%; Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
Placebo Comparator: 2	Drug: vehicle; Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.

Outcome Measures

Primary Outcome Measures

1. Improvement in signs and symptoms of rosacea [16 weeks]

Secondary Outcome Measures

1. Changes in various skin parameters [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Product Investigations, Inc.	Conshohocken	Pennsylvania	United States	19428

Sponsors and Collaborators

• Coria Laboratories, Ltd.

Investigators

• Principal Investigator: Morris V Shelanski, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00621218
• Other Study ID Numbers: 9320-010-002
• First Posted: Feb 22, 2008
• Last Update Posted: Dec 18, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: tretinoin, efficacy, safety, rosacea
• Additional relevant MeSH terms: Rosacea; Tretinoin

Study Results

No Results Posted as of Dec 18, 2008