NCT06965140

CP376 OCT Exploratory Skin Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stoma Ileostomy

Interventions

Type	Name	Description
DEVICE	flat 1-piece open ostomy device	OCT scan and skin measurements of peristomal and abdominal skin

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2025-05-11
• Last updated: 2025-05-18

Locations

1 site across 1 country: Denmark