Phototoxicity Test of Dapsone Gel in Healthy Volunteers

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-05-31

Brief Summary

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This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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All participants

Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.

Group Type EXPERIMENTAL

dapsone gel

Intervention Type DRUG

Patches containing dapsone gel will be applied to the skin.

dapsone gel vehicle

Intervention Type DRUG

Patches containing dapsone gel vehicle will be applied to the skin.

Interventions

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dapsone gel

Patches containing dapsone gel will be applied to the skin.

Intervention Type DRUG

dapsone gel vehicle

Patches containing dapsone gel vehicle will be applied to the skin.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Healthy adults.

Exclusion Criteria

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes