NCT04909983TerminatedNot Applicable
A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
Copenhagen University Hospital at Herlev1 site in 1 country17 target enrollmentStarted: May 19, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Response rate of active treatment versus standard of care
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention
Experimental
Medical Device, an occlusive patch for 3 days.
Intervention: DPLX-PT1 (Device)
Control
Active Comparator
Standard of Care
Intervention: Control arm (Other)
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(After 8 days)
Investigators
Anna Korsgaard Berg
Principal Investigator MD
Copenhagen University Hospital at Herlev
Study Sites (1)
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