IleostomyNCT02351791
An Exploratory Study Investigating Human Skin Reaction to Output
A study testing Patch 1, Patch 2 and Patch 3 in people with Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- Patch 1, Patch 2 and Patch 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Mar 2015
- 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
- No healthy volunteers
- 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 had an ileostomy for more than one year
- Have normal to slightly red skin on the area used in the evaluation
- Has an ileostomy with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for applied patches (assessed by investigator)
Who cannot join
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- Participating in other interventional clinical investigations or have previously participated in this investigation
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
Read the detailed description
Six types of patches are tested:
Patch 1: Standard adhesive with own feces
Patch 2: Standard adhesive with own feces mixture
Patch 3: Standard adhesive with simulated feces
Patch 4: Standard adhesive with simulated feces mixture
Patch 5: Standard adhesive with buffer (control)
Patch 6: Standard adhesive with buffer feces mixture (control)
Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.
A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established
- Conditions
- Ileostomy
- Being tested
- Patch 1, Patch 2, Patch 3, Patch 4, Patch 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch 1Other
Patch 1:standard adhesive with own feces in sleeve
Patch 2Other
Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3Other
Patch 3: standard adhesive with simulated feces in sleeve
Patch 4Other
Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5Other
Patch 5:standard adhesive with buffer in sleeve
Patch 6Other
Patch 6:standard adhesive with buffer mixture in sleeve
| Study group | Role | What they receive |
|---|---|---|
| Patch 1, 3 and 5 | Experimental | Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive. Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: Patch 5; Other: Patch 6 |
| Patch 2, 4 and 6 | Experimental | Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Receives: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: Patch 5; Other: Patch 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans Epidermal Water Loss After Test of Patches.
Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).
Measured: Approximately 7-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene F Nielsen, PhD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351791
- Sponsor's protocol ID
- CP254
- Status last verified
- Sep 2023
- First submitted
- 27 Jan 2015
- Last updated
- 2 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study Investigating Human Skin Reaction to Output
- ClinicalTrials.gov ID
- NCT02351791
- Acronym / sponsor ID
- CP254
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 2 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
Detailed description
Six types of patches are tested:
Patch 1: Standard adhesive with own feces
Patch 2: Standard adhesive with own feces mixture
Patch 3: Standard adhesive with simulated feces
Patch 4: Standard adhesive with simulated feces mixture
Patch 5: Standard adhesive with buffer (control)
Patch 6: Standard adhesive with buffer feces mixture (control)
Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.
A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch 1, 3 and 5 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: Patch 5, Other: Patch 6Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. |
| Patch 2, 4 and 6 | Experimental | Other: Patch 1, Other: Patch 2, Other: Patch 3, Other: Patch 4, Other: Patch 5, Other: Patch 6Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had an ileostomy for more than one year
- Have normal to slightly red skin on the area used in the evaluation
- Has an ileostomy with a diameter up to (≤) 35 mm
Key exclusion criteria (5 listed)
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- Participating in other interventional clinical investigations or have previously participated in this investigation
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 |
|---|---|---|
| Patch 1Patch 1:standard adhesive with own feces in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
| Patch 2Patch 2:standard adhesive with own feces mixture in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
| Patch 3Patch 3: standard adhesive with simulated feces in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
| Patch 4Patch 4:standard adhesive with simulated feces mixture in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
| Patch 5Patch 5:standard adhesive with buffer in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
| Patch 6Patch 6:standard adhesive with buffer mixture in sleeve | Other | Patch 1, 3 and 5, Patch 2, 4 and 6 |
Primary outcome
Trans Epidermal Water Loss After Test of Patches.
Time frame: Approximately 7-10 hours
Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lene F Nielsen, PhD principal investigator
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch 1, Patch 2 and Patch 3 in people with 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 6 inclusion and 5 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 2 Oct 2023. 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 2 Oct 2023). 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?
Trans Epidermal Water Loss After Test of Patches. (time frame: Approximately 7-10 hours). 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 2 Oct 2023.