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Clinical Evaluation of the Photoallergy Potential of Atralin Gel

NCT ID: NCT00603772

Last Updated: 2008-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-03-31

Brief Summary

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To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.

Detailed Description

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Conditions

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Healthy

Keywords

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Tretinoin exposure to UV light phototoxicity Safety when exposed to sunlight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Safety when exposed to sunlight

Group Type EXPERIMENTAL

Atralin (tretinoin) gel, 0.05%

Intervention Type DRUG

Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.

Interventions

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Atralin (tretinoin) gel, 0.05%

Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal, healthy volunteers
* 18 years of age and older

Exclusion Criteria

* Less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coria Laboratories, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Coria Laboratories, Ltd.

Principal Investigators

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Joseph W Stanfield, MS

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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029-066-09-002

Identifier Type: -

Identifier Source: org_study_id