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An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

Primary Purpose

Contact Dermatitis Irritant, Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DPLX-PT1
Control arm
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Dermatitis Irritant

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Pediatric Department, Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Medical Device, an occlusive patch for 3 days.

Standard of Care

Outcomes

Primary Outcome Measures

Response rate of active treatment versus standard of care

Secondary Outcome Measures

Time to resolution of Irritative contact dermatitis

Full Information

First Posted
May 20, 2021
Last Updated
November 17, 2022
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT04909983
Brief Title
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices
Official Title
A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis Irritant, Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Medical Device, an occlusive patch for 3 days.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
DPLX-PT1
Intervention Description
A polymer skin patch for occlusional therapy
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time to resolution of Irritative contact dermatitis
Time Frame
After 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Korsgaard Berg, MD
Organizational Affiliation
Pediatric Department, Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Department, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

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