NCT04044014

Gellan Contact Study

Prospective, Randomized Control Trial to Evaluate the Dermatological Reaction of Healthy Volunteers to Gellan Sheet and Fluid Gel Dressings (Gellan Contact Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).

Detailed description

This contact study is part of the Wellcome trust Anti-scarring Dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. A polysaccharide, Gellan, has been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. Gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. Timoptol XE, Merck Sharp \& Dohme, USA). As part of the development of the dressing, the epidermal (skin) response to Gellan needs to be evaluated to check its safety. The main objective of this study is to establish the safety of the two different Gellan formulations (2% Gellan sheet and 2% Gellan fluid gel) following application to the epidermis (skin).

Conditions

• Thermal Injury
• Skin Burn

Interventions

Type	Name	Description
DEVICE	Gellan sheet	Gellan sheet.
DEVICE	Gellan fluid gel	Gellan fluid gel.
DEVICE	Mepitel One	Control dressing-- Mepitel One.

Timeline

• Start date: 2016-10-10
• Primary completion: 2017-02-13
• Completion: 2017-08-01
• First posted: 2019-08-02
• Last updated: 2019-08-02

Locations

1 site across 1 country: United Kingdom