NCT00645164
Completed
Phase 1
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
Overview
- Phase
- Phase 1
- Intervention
- Ointment Vehicle
- Conditions
- Healthy
- Sponsor
- Healthpoint
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Frequency Distribution of Skin Irritation Scores
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects
Exclusion Criteria
- •Less than 18 years
Arms & Interventions
Xenaderm
Subject serves as own control
Intervention: Ointment Vehicle
Xenaderm
Subject serves as own control
Intervention: Xenaderm
Outcomes
Primary Outcomes
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.
Study Sites (1)
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