Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Almirall

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Normal saline; Drug: dapsone gel vehicle; Drug: dapsone gel; Drug: sodium lauryl sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117752

225678-009

Details and patient eligibility

About

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.

Enrollment: 237 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: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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237 participants in 2 patient groups

Dapsone Gel Subset 1

Experimental group

Description:

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.

Treatment:

Drug: dapsone gel vehicle

Drug: dapsone gel

Drug: sodium lauryl sulfate

Drug: Normal saline

Dapsone Gel Subset 2

Experimental group

Description:

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.

Treatment:

Drug: dapsone gel vehicle

Drug: dapsone gel

Drug: Normal saline