Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Phase 1CompletedNCT00645164

Healthpoint59 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Ointment VehicleOTHER

Subject acts as own control. 20 mg under Finn chambers

XenadermDRUG

20 mg under Finn chambers

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Less than 18 years

Locations (1)

Suncare Research Laboratories

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Frequency Distribution of Skin Irritation Scores

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.

Time frame: 48-hours post irradiation

Data from ClinicalTrials.gov

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