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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03770078
Other study ID # CP300
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2018
Est. completion date March 6, 2019

Study information

Verified date September 2020
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the performance of a new adhesive with regard to the skin condition


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Test Product A
The test product is a newly developed ostomy product

Locations

Country Name City State
Denmark CCBR Aalborg Aalborg
Denmark Coloplast Humlebæk
Denmark CCBR Vejle Vejle
Sweden KTA Prim Stockholm Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trans Epidermal Water Loss Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage Four weeks
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