Evaluation of the Peel Force of New Adhesives From the Skin

This study investigates the impact and adhesion of new adhesives to the skin.

Study Overview

• Status: Completed
• Conditions: Stoma Ileostomy
• Intervention / Treatment: Other: Standard adhesive 1; Other: Standard adhesive 2; Other: Standard adhesive 3; Other: P-4; Other: P-15; Other: P-16

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Testing of 6 adhesive strips; Each subject tests six adhesive strips on pre-striped skin.; Standard adhesive 1; standard adhesive 2; Standard adhesive 3; P-4; P-15; P-16 The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits.

Other: Standard adhesive 1; This strip consists of a standard hydrocolloid adhesive found in ostomy products; Other: Standard adhesive 2; This strip consists of a standard hydrocolloid adhesive found in ostomy products; Other: Standard adhesive 3; This strip consists of a standard hydrocolloid adhesive found in ostomy products; Other: P-4; Newly developed adhesive P-4; Other: P-15; Newly developed adhesive P-14; Other: P-16; Newly developed adhesive P-8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peel Force	The peel force (N) needed to peel off adhesive strips from the skin	30 min

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CP267_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No