An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

Copenhagen University Hospital at Herlev

Status: Terminated

Conditions: Type 1 Diabetes; Contact Dermatitis Irritant

Treatments: Other: Control arm; Device: DPLX-PT1

Study type: Interventional

Funder types: Other

Identifiers

NCT04909983

DPLX-PT01

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Intervention

Experimental group

Description:

Medical Device, an occlusive patch for 3 days.

Treatment:

Device: DPLX-PT1

Control

Active Comparator group

Description:

Standard of Care

Treatment:

Other: Control arm