An Explorative Study of Treatment of Contact Dermatitis D... | NCT04909983

Studies
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

NCT04909983

Sponsor

Copenhagen University Hospital at Herlev

Status

Terminated

Last Update Posted

Nov 22, 2022Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Contact Dermatitis Irritant
Type 1 Diabetes

Interventions

DPLX-PT1
Control arm

Countries

Denmark

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.

Expanded Access Info

Start Date

May 19, 2021Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

Jun 1, 2021

First Posted Date

Jun 2, 2021Actual

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

Nov 17, 2022

Last Update Posted Date

Nov 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna Korsgaard Berg, Principal Investigator MD, Copenhagen University Hospital at HerlevPrincipal Investigator

Lead Sponsor

Copenhagen University Hospital at HerlevOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

A feasibility study of treatment with a occlusive medical device or patch in pediatric patients with type 1 diabetes suffering from irritative contact dermatitis due to diabetes devices.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Medical Device, an occlusive patch for 3 days.	Device: DPLX-PT1
Control	Active Comparator	Standard of Care	Other: Control arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DPLX-PT1	Device	A polymer skin patch for occlusional therapy	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate of active treatment versus standard of care		8 days after active treatment compared to 8 days after standard of care

Secondary Outcomes

Measure	Description	Time Frame
Time to resolution of Irritative contact dermatitis		After 8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent, and for patients under the legal age consent by a legal guardian
Clinically confirmed, active and evaluable irritant contact dermatitis (ICD)
Age 6-20 at the time of signing the informed consent form (ICF)
Ability to answer study questionnaires

Exclusion Criteria:

Any type of skin irritation other than ICD
Use of occlusive therapy for the treatment of their ICD, or unwilling to refrain from this treatment for duration of study
For any other reason considered unsuitable by the investigator
Pregnant or of child-bearing potential unwilling to use acceptable effective contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Korsgaard Berg, MD	Pediatric Department, Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Department, Herlev Hospital		Herlev		2730	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017453	Dermatitis, Irritant
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003877	Dermatitis, Contact
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided