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

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

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 ]

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

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.


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

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 identifier: NCT00621218

United States, Pennsylvania
Product Investigations, Inc.
Conshohocken, Pennsylvania, United States, 19428
Sponsors and Collaborators
Coria Laboratories, Ltd.
Principal Investigator: Morris V Shelanski, MD
  More Information

Responsible Party: D. Innes Cargill, PhD, Coria Laboratories, Ltd. Identifier: NCT00621218     History of Changes
Other Study ID Numbers: 9320-010-002
Study First Received: February 12, 2008
Last Updated: December 17, 2008

Keywords provided by Coria Laboratories, Ltd.:
tretinoin, efficacy, safety, rosacea

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents processed this record on September 19, 2017