Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Xenaderm; Drug: Placebo

• Registration Number: NCT00644917
• Lead Sponsor: Healthpoint

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-27
• Results First Submitted: 2013-10-09
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Results First Posted: 2014-01-13
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Xenaderm	Drug
B	Placebo	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Skin Reaction Score	48 hours	Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.