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The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients

Vulvar Lichen Sclerosus Clinical Trial

Official title:
The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients

Clinical Trial Summary

This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).

Clinical Trial Description

The Rivelin® plain patch works by forming a protective barrier over a lesion, protecting it from further irritation and thus providing pain relief in much the same way as the adhesive pastes and films that are available to treat VLS. However, the adhesion/protection time of the Rivelin® plain patch is expected to be longer compared to current treatment with bioadhesive agents, thereby potentially increasing the pain free period for the subject.

This study is undertaken to gather information covering adhesion time and tolerability of the Rivelin® plain patch on areas affected by VLS. Since protecting a lesion with a physical barrier could reduce the sensation of pain caused by normal function, this investigation will also explore subject experienced pain and/or symptom relief during use of the patch for further development. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03686800
Study type Interventional
Source Dermtreat
Contact
Status Completed
Phase N/A
Start date September 25, 2018
Completion date November 15, 2018
View Details
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