Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: dapsone gel; Drug: dapsone gel vehicle; Drug: sodium lauryl sulfate; Drug: Normal saline

• Registration Number: NCT02117752
• Lead Sponsor: Almirall, S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapsone Gel Subset 1	dapsone gel vehicle	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.
Dapsone Gel Subset 2	dapsone gel vehicle	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.
Dapsone Gel Subset 1	Normal saline	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.
Dapsone Gel Subset 1	dapsone gel	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.
Dapsone Gel Subset 2	dapsone gel	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.
Dapsone Gel Subset 2	Normal saline	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.
Dapsone Gel Subset 1	sodium lauryl sulfate	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Sensitization Reactions During Challenge Phase	6 Weeks
Mean Cumulative Irritation Index During Induction Phase	21 Days