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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients
Zealand University Hospital, Dermatology dpt.
Roskilde, Denmark
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
Time frame: 2 days
Adverse Events
Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation
Time frame: 2 days
Ability to apply patches correctly
Study staff reported observation on subject's ability to apply patches correctly
Time frame: 2 days
Understanding of the Instructions for use leaflet
Subject reported outcome on the understanding of the Instructions for use leaflet
Time frame: 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
Time frame: 2 days
Optimising the design of the patch
Subject responses towards optimising the design of the patch
Time frame: 2 days
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