Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Ointment Vehicle; Drug: Xenaderm

• Registration Number: NCT00645164
• Lead Sponsor: Healthpoint

Brief Summary

The product is being tested to see if exposure to light causes photoallergic reactions on the skin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-27
• Primary Completion: 2008-05
• Study Completion: 2008-06
• Results First Submitted: 2008-10-08
• Results First Submitted QC: 2009-03-04
• Results First Posted: 2009-04-06
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• Less than 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xenaderm	Ointment Vehicle	Subject serves as own control
Xenaderm	Xenaderm	Subject serves as own control

Primary Outcome Measures

Name	Time	Method
Frequency Distribution of Skin Irritation Scores	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.

Trial Locations

Locations (1)

Suncare Research Laboratories; 🇺🇸 Winston-Salem, North Carolina, United States