- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00604032
Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%
March 26, 2008 updated by: Coria Laboratories, Ltd.
Clinical Evaluation of the Phototoxic Potential of Atralin (Tretinoin) Gel, 0.05%
To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as skin reactions 24 and 48 hours after UV radiation of drug on skin.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27106
- Suncare Research Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal healthy volunteers
- 18 years of age or older
Exclusion Criteria:
- Less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
|
Assess potential of tretinoin gel, 0.05% to produce phototoxic reactions, measured 24 and 48 hours after UV radiation of drug on the skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
UV induced skin sensitization
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Stanfiled, MS, Suncare Laboratories
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
January 16, 2008
First Submitted That Met QC Criteria
January 28, 2008
First Posted (Estimate)
January 29, 2008
Study Record Updates
Last Update Posted (Estimate)
March 28, 2008
Last Update Submitted That Met QC Criteria
March 26, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 029-066-09-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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