An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

November 17, 2022 updated by: Anna Korsgaard Berg, Copenhagen University Hospital at Herlev

A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

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

  • Denmark
      • Herlev, Denmark, 2730
        • Pediatric Department, Herlev Hospital

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

6 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Medical Device, an occlusive patch for 3 days.
Device: DPLX-PT1
A polymer skin patch for occlusional therapy
ACTIVE_COMPARATOR: Control
Standard of Care
Other: Control arm
Standard of care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Anna Korsgaard Berg, MD, Pediatric Department, Herlev Hospital

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 (ACTUAL)

May 19, 2021

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

October 1, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (ACTUAL)

June 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPLX-PT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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