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

This study has been completed.
Sponsor:
Information provided by:
Coria Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00621218
First received: February 12, 2008
Last updated: December 17, 2008
Last verified: December 2008
  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 2

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:


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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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 April 17, 2014