CP376 OCT Exploratory Skin Study

Not Applicable

Completed

• Conditions: Stoma Ileostomy

• Registration Number: NCT06965140
• Lead Sponsor: Coloplast A/S

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-07
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-05-01
• Primary Completion: 2025-05-02
• Study Completion: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

1. Is currently receiving or have within the past two months received radio-and/or chemotherapy
2. 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
3. Is pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Thickness of the epidermal layer (assessed by OCT)	immediately after the OCT scan	Scan of the peristomal skin

Trial Locations

Locations (1)

Bispebjerg Hospital, Department of dermatology and venerology; 🇩🇰 Copenhagen, Denmark