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Completed

NCT Number: NCT03686800

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).

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Key information

Conditions

Vulvar Lichen Sclerosus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital, Dermatology dpt.

Roskilde, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivelin® plain patches

Device

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

Primary outcomes

  1. 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 outcomes

  1. Adverse Events

    Time frame: 2 days

    Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation

  2. Ability to apply patches correctly

    Time frame: 2 days

    Study staff reported observation on subject's ability to apply patches correctly

  3. Understanding of the Instructions for use leaflet

    Time frame: 2 days

    Subject reported outcome on the understanding of the Instructions for use leaflet

  4. 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

  5. Optimising the design of the patch

    Time frame: 2 days

    Subject responses towards optimising the design of the patch

Sponsors and collaborators

Lead sponsor

Dermtreat

Industry

Collaborators

  • Larix A/S

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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