Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117752

Enrollment

237

Registered

2014-04-21

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGdapsone gel

Patches containing dapsone gel will be applied to the skin.

DRUGdapsone gel vehicle

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

DRUGsodium lauryl sulfate

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

DRUGNormal saline

Patches containing normal saline (Negative Control) will be applied to the skin.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026