Study Stopped
Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices
A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedNovember 22, 2022
November 1, 2022
1.4 years
May 20, 2021
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate of active treatment versus standard of care
8 days after active treatment compared to 8 days after standard of care
Secondary Outcomes (1)
Time to resolution of Irritative contact dermatitis
After 8 days
Study Arms (2)
Intervention
EXPERIMENTALMedical Device, an occlusive patch for 3 days.
Control
ACTIVE COMPARATORStandard of Care
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Department, Herlev Hospital
Herlev, 2730, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Korsgaard Berg, MD
Pediatric Department, Herlev Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator MD
Study Record Dates
First Submitted
May 20, 2021
First Posted
June 2, 2021
Study Start
May 19, 2021
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
November 22, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share