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Dermal Tolerability of Dapsone Gel in Healthy Volunteers

NCT02117752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

dapsone gel

Patches containing dapsone gel will be applied to the skin.

DRUG

dapsone gel vehicle

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

DRUG

sodium lauryl sulfate

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

DRUG

Normal saline

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

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117752 on ClinicalTrials.gov