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NCT04909983 Clinical Trial

An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04909983
Other study ID # DPLX-PT01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 19, 2021
Est. completion date October 1, 2022

Study information
Verified date November 2022
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 20 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• DPLX-PT1
A polymer skin patch for occlusional therapy
Other:
• Control arm
Standard of care

Locations
Country Name City State
Denmark Pediatric Department, Herlev Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate of active treatment versus standard of care 8 days after active treatment compared to 8 days after standard of care
Secondary Time to resolution of Irritative contact dermatitis After 8 days
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