Development of a Skin Fragility Assessment Tool


Investigator: Robyn Hickerson

Institution: Dundee University, Scotland

Grant: £38,225.00

Starting date: 1st September 2015

Lay Summary

This project was granted funding to develop a skin fragility assessment tool to obtain objective clinical endpoints. These clinical endpoints are a meaningful measurement that helps map the occurrence of a particular disease or condition. In this case it will be for patients with all types of EB as well as other blistering disorders as there is a major requirement for research in this area needed.

The team at Dundee have designed the device that will allow a clinician to objectively and reproducibly measure multiple variables related to the minimum amount of trauma required to form a blister. The aims were to: (1) optimise the current design; (2) add the optics necessary to measure changes in the skin that are undetectable by eye; (3) test the device on control and EB patient volunteers; and (4) gain ethics and regulatory approval.

Clinical endpoints that are carried out by a dermatologist such as the number and the size of blisters are considered to be subjective measurements. However, collecting data on objective clinical endpoints is difficult to do. The tool will collect data on processes in the skin that have been subjected to blistering by performing a special kind of imaging of the skin that is being subjected to friction, so as to detect any changes (e.g. oxygenation, keratinocyte rupture) that precede macroscopic blistering.

The instrument will be built, tested and validated on both healthy volunteers as well as EBS patient volunteers. By identifying and validating these objective clinical endpoints, it will provide data in preparation for clinical trials in EBS.