The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Primary Purpose
Vulvar Lichen Sclerosus
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rivelin® plain patches
Sponsored by
About this trial
This is an interventional basic science trial for Vulvar Lichen Sclerosus focused on measuring VLS
Eligibility Criteria
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
Sites / Locations
- Zealand University Hospital, Dermatology dpt.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rivelin® plain patches
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse Events
Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation
Ability to apply patches correctly
Study staff reported observation on subject's ability to apply patches correctly
Understanding of the Instructions for use leaflet
Subject reported outcome on the understanding of the Instructions for use leaflet
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
Optimising the design of the patch
Subject responses towards optimising the design of the patch
Full Information
NCT ID
NCT03686800
First Posted
September 24, 2018
Last Updated
March 15, 2019
Sponsor
Dermtreat
Collaborators
Larix A/S
1. Study Identification
Unique Protocol Identification Number
NCT03686800
Brief Title
The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Official Title
The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermtreat
Collaborators
Larix A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
Keywords
VLS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivelin® plain patches
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Rivelin® plain patches
Intervention Description
The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients
Primary Outcome Measure Information:
Title
Adhesion time for Rivelin® plain patches
Description
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
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation
Time Frame
2 days
Title
Ability to apply patches correctly
Description
Study staff reported observation on subject's ability to apply patches correctly
Time Frame
2 days
Title
Understanding of the Instructions for use leaflet
Description
Subject reported outcome on the understanding of the Instructions for use leaflet
Time Frame
2 days
Title
Visual analogue scale (VAS) scores
Description
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
Title
Optimising the design of the patch
Description
Subject responses towards optimising the design of the patch
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor B.E. Jemec, MD
Organizational Affiliation
Zealand University Hospital, Dermatology dpt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital, Dermatology dpt.
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
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