NCT03686800

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dermtreat · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	Rivelin® plain patches	The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients

Timeline

• Start date: 2018-09-25
• Primary completion: 2018-11-15
• Completion: 2018-11-15
• First posted: 2018-09-27
• Last updated: 2019-03-19

Locations

1 site across 1 country: Denmark