Investigating the Adhesion of New Adhesive to the Skin

Status Enrolling by invitation

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Ileostomy - Stoma

Clinical Trial Details

NCT number	NCT03439176
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	January 15, 2018
Completion date	June 30, 2020

View Details

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