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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Device: Rivelin® plain patches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women (≥ 18 years) diagnosed with VLS Has received written and oral study information Has given her written consent to study participation Exclusion Criteria: Pregnant Menstruating at the time of patch application Unable to communicate clearly with the examining doctors Under the guardianship of another person or institution

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivelin® plain patches<br>This is an open label study with the objectives to establish information on adhesion time, tolerability and usability of Rivelin® plain patches when applied to VLS lesions. Furthermore, the design of the Rivelin® plain patch will also be evaluated. | Device: Rivelin® plain patches<br>* The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion time for Rivelin® plain patches | The proportion of successful applications of Rivelin® plain patches (defined as an adhesion time ≥ 30 min); separate summaries for morning and evening applications | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation | 2 days | 
| Ability to apply patches correctly | Study staff reported observation on subject's ability to apply patches correctly | 2 days | 
| Understanding of the Instructions for use leaflet | Subject reported outcome on the understanding of the Instructions for use leaflet | 2 days | 
| Visual analogue scale (VAS) scores | Visual analogue scale (VAS) scores for discomfort, pain, itching and burning prior to applying the first patch, at 2 hours after application (or when the first patch detaches) and on day 2 | 2 days | 
| Optimising the design of the patch | Subject responses towards optimising the design of the patch | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLS