An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

Copenhagen University Hospital at Herlev17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contact Dermatitis Irritant Type 1 Diabetes

Interventions

DPLX-PT1DEVICE

A polymer skin patch for occlusional therapy

Control armOTHER

Standard of care

Eligibility

Sex: ALLMin age: 6 YearsMax age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Pediatric Department, Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Response rate of active treatment versus standard of care

Time frame: 8 days after active treatment compared to 8 days after standard of care

Secondary Outcomes

Time to resolution of Irritative contact dermatitis

Time frame: After 8 days

Data from ClinicalTrials.gov

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