Photoallergy Potential of Dapsone Gel in Healthy Volunteers | NCT02117739

Studies
Photoallergy Potential of Dapsone Gel in Healthy Volunteers

NCT02117739

Sponsor

Almirall, S.A.

Status

Completed

Last Update Posted

Oct 9, 2018Actual

Enrollment

58Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

dapsone gel
dapsone gel vehicle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 16, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2018

Last Update Posted Date

Oct 9, 2018Actual

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All Participants	Experimental	Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches twice a week for 21 days followed by a 10 to 17 day rest period then another application of dapsone gel and dapsone gel vehicle by patch.	Drug: dapsone gel Drug: dapsone gel vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dapsone gel	Drug	Patches containing dapsone gel will be applied to the skin.	All Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Photoallergic (Sensitizing) Potential Using a Visual Scale		Week 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Allergan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Fair Lawn	New Jersey		United States