Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

NCT ID: NCT00645164

Last Updated: 2010-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xenaderm

Subject serves as own control

Group Type EXPERIMENTAL

Ointment Vehicle

Intervention Type OTHER

Subject acts as own control. 20 mg under Finn chambers

Xenaderm

Intervention Type DRUG

20 mg under Finn chambers

Interventions

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Ointment Vehicle

Subject acts as own control. 20 mg under Finn chambers

Intervention Type OTHER

Xenaderm

20 mg under Finn chambers

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects

Exclusion Criteria

* Less than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Healthpoint

INDUSTRY

Sponsor Role lead

Responsible Party

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Healthpoint

Principal Investigators

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Joe Stanfield, PhD

Role: PRINCIPAL_INVESTIGATOR

Suncare Research Laboratories

Locations

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Suncare Research Laboratories

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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011 101 09 002

Identifier Type: -

Identifier Source: org_study_id

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