- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645164
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
June 1, 2010 updated by: Healthpoint
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
Study Overview
Study Type
Interventional
Enrollment (Actual)
59
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
- 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Less than 18 years
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: N/A
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Xenaderm
Subject serves as own control
|
Subject acts as own control.
20 mg under Finn chambers
20 mg under Finn chambers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency Distribution of Skin Irritation Scores
Time Frame: 48-hours post irradiation
|
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.
Photoallergic reactions were characterized by irritation scores of 3 or higher.
|
48-hours post irradiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joe Stanfield, PhD, Suncare Research 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
March 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
March 24, 2008
First Submitted That Met QC Criteria
March 24, 2008
First Posted (Estimate)
March 27, 2008
Study Record Updates
Last Update Posted (Estimate)
June 8, 2010
Last Update Submitted That Met QC Criteria
June 1, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011 101 09 002
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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