Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

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

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Suncare Research Laboratories

Winston-Salem, North Carolina, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy subjects

Exclusion criteria

Less than 18 years

Treatment and study plan

Ointment Vehicle

Other

Subject acts as own control. 20 mg under Finn chambers

Xenaderm

Drug

20 mg under Finn chambers

Primary outcomes

Frequency Distribution of Skin Irritation Scores

Time frame: 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.

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: Jun 8, 2010

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