A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 18, 2008
December 1, 2008
2 months
February 12, 2008
December 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in signs and symptoms of rosacea
16 weeks
Secondary Outcomes (1)
Changes in various skin parameters
16 weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea
Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.
Eligibility Criteria
You may qualify if:
- Female
- Age 18-65
- Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea
You may not qualify if:
- Male, females less than 18 years
- Females over 65 years
- No diagnosed rosacea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Product Investigations, Inc.
Conshohocken, Pennsylvania, 19428, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morris V Shelanski, MD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 22, 2008
Study Start
February 1, 2008
Primary Completion
April 1, 2008
Study Completion
December 1, 2008
Last Updated
December 18, 2008
Record last verified: 2008-12