Investigating the Adhesion of New Adhesive to the Skin

NCT ID: NCT03439176

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2020-06-30

Brief Summary

The adhesion of the new adhesive strips is investigated on healthy volunteers

Detailed Description

Inclusion visit:

• Introduction to the study
• Inclusion in study
• Baseline information is obtained
• Instruct subject to pre-strip of abdominal skin

Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin):

• Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip)
• Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Adhesive strips are weighted and applied
• Potential shower/bicycle exercise (max 60 minutes)
• Adhesive strips are removed at pre-defined timeslots (peel force measured)
• Discomfort when strip was peeled of is evaluated by subject (VAS)
• Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Acclimatization ½
• Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip))
• Adhesive strips are weighed
• Photo of adhesive strips

The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.

Conditions

Ileostomy - Stoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test of new adhesive strips

The subjects will test adhesives strips made of 4 different adhesives:

Standard adhesive 1 Standard adhesive 2 PL4 PL16-L

Group Type: EXPERIMENTAL

Standard adhesive 1

Intervention Type: OTHER

This strip contains a standard hydrocolloid adhesive found in ostomy devices

Standard adhesive 2

Intervention Type: OTHER

This strip contains a standard hydrocolloid adhesive found in ostomy devices

PL4

Intervention Type: OTHER

This strip contains a new adhesive

PL16-L

Intervention Type: OTHER

This strip contains a new adhesive

Interventions

Standard adhesive 1

This strip contains a standard hydrocolloid adhesive found in ostomy devices

Intervention Type: OTHER

Standard adhesive 2

This strip contains a standard hydrocolloid adhesive found in ostomy devices

Intervention Type: OTHER

PL4

This strip contains a new adhesive

Intervention Type: OTHER

PL16-L

This strip contains a new adhesive

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lene F Nielsen

Role: PRINCIPAL_INVESTIGATOR

Head of the pre-clinical department

Locations

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Other Identifiers

CP267_3_5

Identifier Type: -

Identifier Source: org_study_id