Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Almirall, S.A.237 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

237

Conditions

Healthy Volunteers

Interventions

dapsone gelDRUG

Patches containing dapsone gel will be applied to the skin.

dapsone gel vehicleDRUG

Patches containing dapsone gel vehicle will be applied to the skin.

sodium lauryl sulfateDRUG

Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

Mean Cumulative Irritation Index During Induction Phase

Time frame: 21 Days

Incidence of Sensitization Reactions During Challenge Phase

Time frame: 6 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.