Contact Dermatitis IrritantNCT04909983
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices
A study testing DPLX-PT1 in people with Contact Dermatitis Irritant and Type 1 Diabetes, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Contact Dermatitis Irritant, Type 1 Diabetes
- What is being tested?
- DPLX-PT1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 19 May 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
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.
- Conditions
- Contact Dermatitis Irritant, Type 1 Diabetes
- Being tested
- DPLX-PT1, Control arm
- Medical subject headings
- Dermatitis, Irritant, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPLX-PT1Device
A polymer skin patch for occlusional therapy
Control armOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Medical Device, an occlusive patch for 3 days. Receives: Device: DPLX-PT1 |
| Control | Active comparator | Standard of Care Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of active treatment versus standard of care
Measured: 8 days after active treatment compared to 8 days after standard of care
Secondary outcomes (1)
Time to resolution of Irritative contact dermatitis
Measured: After 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start19 May 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Dermatitis IrritantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Korsgaard Berg, Copenhagen University Hospital at Herlev
- Investigators
- Anna Korsgaard Berg, MD, Principal investigator, Pediatric Department, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909983
- Sponsor's protocol ID
- DPLX-PT01
- Status last verified
- Nov 2022
- First submitted
- 20 May 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor
- ClinicalTrials.gov ID
- NCT04909983
- Acronym / sponsor ID
- DPLX-PT01
- Conditions
- Contact Dermatitis Irritant, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: DPLX-PT1Medical Device, an occlusive patch for 3 days. |
| Control | Active comparator | Other: Control armStandard of Care |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPLX-PT1A polymer skin patch for occlusional therapy | Device | Intervention |
| Control armStandard of care | Other | Control |
Primary outcome
Response rate of active treatment versus standard of care
Time frame: 8 days after active treatment compared to 8 days after standard of care
1 secondary outcome
Time to resolution of Irritative contact dermatitis
Time frame: After 8 days
Results and safety
The study was stopped early (reason given: Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Korsgaard Berg, MD principal investigator
Pediatric Department, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPLX-PT1 in people with Contact Dermatitis Irritant and Type 1 Diabetes, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped after 17/20 participants due to lack of time after a prolonged recrutiment period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of active treatment versus standard of care (time frame: 8 days after active treatment compared to 8 days after standard of care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.