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

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

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).

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.

Inclusion Criteria:

1. Women (≥ 18 years) diagnosed with VLS
2. Has received written and oral study information
3. Has given her written consent to study participation

Exclusion Criteria:

1. Pregnant
2. Menstruating at the time of patch application
3. Unable to communicate clearly with the examining doctors
4. Under the guardianship of another person or institution