Dermal Tolerability of Dapsone Gel in Healthy Volunteers

October 5, 2018 updated by: Almirall, S.A.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapsone Gel Subset 1
Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.
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.
Experimental: Dapsone Gel Subset 2
Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.
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: Normal saline
Patches containing normal saline (Negative Control) will be applied to the skin.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almirall, S.A.

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225678-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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