An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

NCT ID: NCT04909983

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2022-10-01

Brief Summary

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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

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Conditions

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Contact Dermatitis Irritant Type 1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Medical Device, an occlusive patch for 3 days.

Group Type EXPERIMENTAL

DPLX-PT1

Intervention Type DEVICE

A polymer skin patch for occlusional therapy

Control

Standard of Care

Group Type ACTIVE_COMPARATOR

Control arm

Intervention Type OTHER

Standard of care

Interventions

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DPLX-PT1

A polymer skin patch for occlusional therapy

Intervention Type DEVICE

Control arm

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Anna Korsgaard Berg

Principal Investigator MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Korsgaard Berg, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Department, Herlev Hospital

Locations

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Pediatric Department, Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DPLX-PT01

Identifier Type: -

Identifier Source: org_study_id

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