Photoallergy Potential of Dapsone Gel in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: dapsone gel; Drug: dapsone gel vehicle

• Registration Number: NCT02117739
• Lead Sponsor: Almirall, S.A.

Brief Summary

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.

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: 58

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	dapsone gel vehicle	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.
All Participants	dapsone gel	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.

Primary Outcome Measures

Name	Time	Method
Photoallergic (Sensitizing) Potential Using a Visual Scale	Week 6