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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00621218
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Coria Laboratories, Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea
Drug Information available for: Tretinoin

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Improvement in signs and symptoms of rosacea [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Changes in various skin parameters [ Time Frame: 16 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621218


Locations
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United States, Pennsylvania
Product Investigations, Inc.
Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
Coria Laboratories, Ltd.
Investigators
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Principal Investigator: Morris V Shelanski, MD
More Information
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Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier: NCT00621218    
Other Study ID Numbers: 9320-010-002
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008
Keywords provided by Coria Laboratories, Ltd.:
tretinoin, efficacy, safety, rosacea
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Tretinoin
 Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents