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Completed

NCT Number: NCT06965140

CP376 OCT Exploratory Skin Study

An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

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Key information

Conditions

Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Department of dermatology and venerology

Copenhagen, 2400, Denmark

About this study

An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT)

12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.

The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.

The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has given written informed consent
  • Is at least 18 years old
  • Has full legal capacity
  • Has an ileostomy
  • Is using a flat 1-piece open ostomy device
  • Have had the ileostomy for a year

Exclusion criteria

  • Is currently receiving or have within the past two months received radio-and/or chemotherapy
  • Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
  • Is pregnant or breastfeeding

Treatment and study plan

flat 1-piece open ostomy device

Device

OCT scan and skin measurements of peristomal and abdominal skin

Primary outcomes

  1. Thickness of the epidermal layer (assessed by OCT)

    Time frame: immediately after the OCT scan

    Scan of the peristomal skin

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

An Explorative Study Investigating Differences on the Peristomal Skin Condition by Optical Coherence Tomography (OCT)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 11, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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