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

Tracking Information

First Received Date ^ICMJE

February 12, 2008

Last Updated Date

December 17, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in signs and symptoms of rosacea [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00621218 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in various skin parameters [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rosacea

Intervention ^ICMJE

Drug: tretinoin gel 0.05%
Drug: vehicle

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00621218

Responsible Party

D. Innes Cargill, PhD, Coria Laboratories, Ltd.

Study ID Numbers ^ICMJE

9320-010-002

Study Sponsor ^ICMJE

Coria Laboratories, Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Morris V Shelanski, MD

Unaffiliated

Information Provided By

Coria Laboratories, Ltd.

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP