Back to resultsA Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tretinoin gel 0.05%
vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring tretinoin, efficacy, safety, rosacea
Eligibility 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
Sites / Locations
- Product Investigations, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Improvement in signs and symptoms of rosacea
Secondary Outcome Measures
Changes in various skin parameters
Full Information
NCT ID
NCT00621218
First Posted
February 12, 2008
Last Updated
December 17, 2008
Sponsor
Coria Laboratories, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00621218
Brief Title
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Coria Laboratories, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
tretinoin, efficacy, safety, rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tretinoin gel 0.05%
Intervention Description
Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
Intervention Type
Drug
Intervention Name(s)
vehicle
Intervention Description
Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
Primary Outcome Measure Information:
Title
Improvement in signs and symptoms of rosacea
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Changes in various skin parameters
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris V Shelanski, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Product Investigations, Inc.
City
Conshohocken
State/Province
Pennsylvania
ZIP/Postal Code
19428
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
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