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

This study has been completed.

First Received on February 12, 2008. Last Updated on December 17, 2008 History of Changes

Sponsor:	Coria Laboratories, Ltd.
Information provided by:	Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00621218

Purpose

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	Intervention	Phase
Rosacea	Drug: tretinoin gel 0.05% Drug: vehicle	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Tretinoin

U.S. FDA Resources

Further study details as provided by Coria Laboratories, Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	36
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621218

Locations

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

Sponsors and Collaborators

Coria Laboratories, Ltd.

Investigators

Principal Investigator:

Morris V Shelanski, MD

More Information

No publications provided

Responsible Party:	D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:	NCT00621218 History of Changes
Other Study ID Numbers:	9320-010-002
Study First Received:	February 12, 2008
Last Updated:	December 17, 2008
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Coria Laboratories, Ltd.:

tretinoin, efficacy, safety, rosacea

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Tretinoin
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012