Evaluation of the Peel Force of New Adhesives From the Skin

NCT03200444 | Completed Results

• 1 other identifier: CP267_01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Peel Force

  The peel force (N) needed to peel off adhesive strips from the skin

  30 min

Study Arms (1)

Testing of 6 adhesive strips

EXPERIMENTAL

Each subject tests six adhesive strips on pre-striped skin. 1. Standard adhesive 1 2. standard adhesive 2 3. Standard adhesive 3 4. P-4 5. P-15 6. 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; Other: Standard adhesive 2; Other: Standard adhesive 3; Other: P-4; Other: P-15; Other: P-16

Interventions

Standard adhesive 1 OTHER

This strip consists of a standard hydrocolloid adhesive found in ostomy products

Testing of 6 adhesive strips

Standard adhesive 2 OTHER

This strip consists of a standard hydrocolloid adhesive found in ostomy products

Testing of 6 adhesive strips

Standard adhesive 3 OTHER

This strip consists of a standard hydrocolloid adhesive found in ostomy products

Testing of 6 adhesive strips

P-4 OTHER

Newly developed adhesive P-4

Testing of 6 adhesive strips

P-15 OTHER

Newly developed adhesive P-14

Testing of 6 adhesive strips

P-16 OTHER

Newly developed adhesive P-8

Testing of 6 adhesive strips

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

MeSH Terms

Interventions

Cyclin-Dependent Kinase Inhibitor p15; Cyclin-Dependent Kinase Inhibitor p16

Intervention Hierarchy (Ancestors)

Cyclin-Dependent Kinase Inhibitor Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Cell Cycle Proteins; Proteins; Tumor Suppressor Proteins; Neoplasm Proteins

Results Point of Contact

• Title: Director of Pre-Clinical Research
• Organization: Coloplast A/S

dklfn@coloplast.com

49111111

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 27, 2017
• Study Start: July 3, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)