Stoma IleostomyNCT03200444
Evaluation of the Peel Force of New Adhesives From the Skin
A study testing Standard adhesive 1, Standard adhesive 2 and Standard adhesive 3 in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This study investigates the impact and adhesion of new adhesives to the skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- Standard adhesive 1, Standard adhesive 2 and Standard adhesive 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have intact skin on the area used in the investigation
Who cannot join
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal area (assessed by investigator)
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the impact and adhesion of new adhesives to the skin.
- Conditions
- Stoma Ileostomy
- Being tested
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3, P-4, P-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard adhesive 1Other
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 2Other
This strip consists of a standard hydrocolloid adhesive found in ostomy products
Standard adhesive 3Other
This strip consists of a standard hydrocolloid adhesive found in ostomy products
P-4Other
Newly developed adhesive P-4
P-15Other
Newly developed adhesive P-14
P-16Other
Newly developed adhesive P-8
| Study group | Role | What they receive |
|---|---|---|
| Testing of 6 adhesive strips | Experimental | Each subject tests six adhesive strips on pre-striped skin.
1. Standard adhesive 1
2. standard adhesive 2
3. Standard adhesive 3
4. P-4
5. P-15
6. P-16
The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. Receives: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: Standard adhesive 3; Other: P-4; Other: P-15; Other: P-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peel Force
The peel force (N) needed to peel off adhesive strips from the skin
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start3 Jul 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stoma IleostomyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200444
- Sponsor's protocol ID
- CP267_01
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2017
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Peel Force of New Adhesives From the Skin
- ClinicalTrials.gov ID
- NCT03200444
- Acronym / sponsor ID
- CP267_01
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the impact and adhesion of new adhesives to the skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing of 6 adhesive strips | Experimental | Other: Standard adhesive 1, Other: Standard adhesive 2, Other: Standard adhesive 3, Other: P-4, Other: P-15, Other: P-16Each subject tests six adhesive strips on pre-striped skin. 1. Standard adhesive 1 2. standard adhesive 2 3. Standard adhesive 3 4. P-4 5. P-15 6. P-16 The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have intact skin on the area used in the investigation
Key exclusion criteria (4 listed)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Have dermatological problems in the abdominal area (assessed by investigator)
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 |
|---|---|---|
| Standard adhesive 1This strip consists of a standard hydrocolloid adhesive found in ostomy products | Other | Testing of 6 adhesive strips |
| Standard adhesive 2This strip consists of a standard hydrocolloid adhesive found in ostomy products | Other | Testing of 6 adhesive strips |
| Standard adhesive 3This strip consists of a standard hydrocolloid adhesive found in ostomy products | Other | Testing of 6 adhesive strips |
| P-4Newly developed adhesive P-4 | Other | Testing of 6 adhesive strips |
| P-15Newly developed adhesive P-14 | Other | Testing of 6 adhesive strips |
| P-16Newly developed adhesive P-8 | Other | Testing of 6 adhesive strips |
Primary outcome
Peel Force
Time frame: 30 min
The peel force (N) needed to peel off adhesive strips from the skin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard adhesive 1, Standard adhesive 2 and Standard adhesive 3 in people with Stoma Ileostomy, run by Coloplast A/S 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 3 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: finished, as of the sponsor's last update on 25 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peel Force (time frame: 30 min). 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 25 Apr 2025.