Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

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

Completed

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Key information

Conditions

Healthy Dermatitis Dermatitis, Contact Dermatitis, Irritant Dermatitis, Phototoxic Photosensitivity Disorders Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects

Exclusion criteria

Under 18 years of age

Treatment and study plan

Xenaderm

Drug

20mg under Finn chambers

Placebo

Drug

20mg under Finn chambers

Primary outcomes

Skin Reaction Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Mar 27, 2008
Registry last updated: Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed