ClinicalTrials.gg
CompletedNCT05641168Updated Sep 4, 2025

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

An interventional study of Adhesive material and Standard adhesive material in Skin Abnormalities, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2021, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study investigates different adhesive materials on healthy and peristomal skin

02

Conditions studied

  • Skin Abnormalities

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03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's enrollment of 114 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has given written consent
  • Be at least 18 years of age and have full legal capacity
  • Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion criteria

Exclusion Criteria:

  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past month received topical treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment
  • Are pregnant or breastfeeding
  • Having dermatological problems in the abdominal area (assessed by investigator)
  • Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Ostomy Adhesive material

    Newly designed ostomy adhesive material

    Other: Adhesive material

  • Other
    comparator adhesive material

    Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product

    Other: Standard adhesive material

Interventions

  • OtherAdhesive material

    Newly developed adhesive material

  • OtherStandard adhesive material

    Standard adhesive material

06

What researchers measure

Primary outcomes

  1. Adherent area

    Adherent area (assessed by photos of adhesive materials)

    Time frame: At every material change throughout the study, an average of 1 week

07

Study locations

1 site
  • Coloplast Research Unit/Userlab
    Humlebæk, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05641168
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Apr 28, 2021
Primary completion
May 30, 2024
Completion
May 30, 2024
Last update
Sep 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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