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

Overview

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).

Full Title of Study: “The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 15, 2018

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.

Interventions

  • Device: Rivelin® plain patches
    • The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients

Arms, Groups and Cohorts

  • Experimental: Rivelin® plain patches
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Adverse Events
    • Time Frame: 2 days
    • Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation
  • Ability to apply patches correctly
    • Time Frame: 2 days
    • Study staff reported observation on subject’s ability to apply patches correctly
  • Understanding of the Instructions for use leaflet
    • Time Frame: 2 days
    • Subject reported outcome on the understanding of the Instructions for use leaflet
  • Visual analogue scale (VAS) scores
    • Time Frame: 2 days
    • 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
  • Optimising the design of the patch
    • Time Frame: 2 days
    • Subject responses towards optimising the design of the patch

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dermtreat
  • Collaborator
    • Larix A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gregor B.E. Jemec, MD, Principal Investigator, Zealand University Hospital, Dermatology dpt.

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