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OpenTrials
Completed

NCT Number: NCT00621218

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Product Investigations, Inc.

Conshohocken, Pennsylvania, 19428, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tretinoin gel 0.05%

Drug

Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea

Vehicle

Drug

Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.

Primary outcomes

  1. Improvement in signs and symptoms of rosacea

    Time frame: 16 weeks

Secondary outcomes

  1. Changes in various skin parameters

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Coria Laboratories, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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