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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014