Phototoxicity Test of Dapsone Gel in Healthy Volunteers

Phase 1

Completed

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

• Registration Number: NCT02108483
• Lead Sponsor: Almirall, S.A.

Brief Summary

This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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	Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.
All participants	dapsone gel vehicle	Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.

Primary Outcome Measures

Name	Time	Method
Phototoxicity Irritation Potential Using a Visual Scale	4 Days