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).

Study Overview

• Status: Completed
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: Rivelin® plain patches

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Zealand University Hospital, Dermatology dpt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Rivelin® plain patches; The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dermtreat
• Collaborators: Larix A/S
• Investigators: Principal Investigator: Gregor B.E. Jemec, MD, Zealand University Hospital, Dermatology dpt.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: VLS
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: DT-001-R-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No