Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

Phase 1CompletedNCT00644917

Healthpoint38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

XenadermDRUG

20mg under Finn chambers

PlaceboDRUG

20mg under Finn chambers

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Under 18 years of age

Outcomes

Primary Outcomes

Skin Reaction Score

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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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