Photoallergy Potential of Dapsone Gel in Healthy Volunteers

Almirall, S.A.58 enrolled

Overview

This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

dapsone gelDRUG

Patches containing dapsone gel will be applied to the skin.

dapsone gel vehicleDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

Photoallergic (Sensitizing) Potential Using a Visual Scale

Time frame: Week 6

Data from ClinicalTrials.gov

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