Contact Dermatitis Irritant, Type 1 Diabetes
Conditions
Brief 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.
Interventions
DEVICEDPLX-PT1
A polymer skin patch for occlusional therapy
OTHERControl arm
Standard of care
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of active treatment versus standard of care | 8 days after active treatment compared to 8 days after standard of care |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of Irritative contact dermatitis | After 8 days |
Countries
Denmark
Outcome results
None listed