Photoallergy Potential of Dapsone Gel in Healthy Volunteers

Almirall

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: dapsone gel vehicle; Drug: dapsone gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117739

225678-011

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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58 participants in 1 patient group

All Participants

Experimental group

Description:

Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches twice a week for 21 days followed by a 10 to 17 day rest period then another application of dapsone gel and dapsone gel vehicle by patch.

Treatment:

Drug: dapsone gel vehicle

Drug: dapsone gel