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

Information source: Coria Laboratories, Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rosacea

Intervention: tretinoin gel 0.05% (Drug); vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Coria Laboratories, Ltd.

Official(s) and/or principal investigator(s):
Morris V Shelanski, MD, Principal Investigator


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.

Clinical Details

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

Primary outcome: Improvement in signs and symptoms of rosacea

Secondary outcome: Changes in various skin parameters


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.


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

Locations and Contacts

Product Investigations, Inc., Conshohocken, Pennsylvania 19428, United States
Additional Information

Starting date: February 2008
Last updated: December 17, 2008

Page last updated: August 23, 2015

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