NCT02117752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

April 16, 2014

Last Update Submit

October 5, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Mean Cumulative Irritation Index During Induction Phase

    21 Days

  • Incidence of Sensitization Reactions During Challenge Phase

    6 Weeks

Study Arms (2)

Dapsone Gel Subset 1

EXPERIMENTAL

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 gelDrug: dapsone gel vehicleDrug: sodium lauryl sulfateDrug: Normal saline

Dapsone Gel Subset 2

EXPERIMENTAL

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 gelDrug: dapsone gel vehicleDrug: Normal saline

Interventions

dapsone gelDRUG

Patches containing dapsone gel will be applied to the skin.

Dapsone Gel Subset 1Dapsone Gel Subset 2
dapsone gel vehicleDRUG

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

Dapsone Gel Subset 1Dapsone Gel Subset 2
sodium lauryl sulfateDRUG

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

Dapsone Gel Subset 1
Normal salineDRUG

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

Dapsone Gel Subset 1Dapsone Gel Subset 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults.

You may not qualify if:

  • Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
  • Sensitivity to adhesive bandages or tape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Fair Lawn, New Jersey, United States

Location

MeSH Terms

Interventions

Sodium Dodecyl SulfateSaline Solution

Intervention Hierarchy (Ancestors)

DodecanolFatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipidsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

US(1)