Dermal Tolerability 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

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dapsone Gel Subset 1

Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.

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.

sodium lauryl sulfate

Intervention Type DRUG

Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.

Normal saline

Intervention Type DRUG

Patches containing normal saline (Negative Control) will be applied to the skin.

Dapsone Gel Subset 2

Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.

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.

Normal saline

Intervention Type DRUG

Patches containing normal saline (Negative Control) 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

sodium lauryl sulfate

Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.

Intervention Type DRUG

Normal saline

Patches containing normal saline (Negative Control) 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