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

Vulvar Lichen Sclerosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686800
• Other study ID #: DT-001-R-002
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: March 2019
• Source: Dermtreat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

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

Locations

Country	Name	City	State
Denmark	Zealand University Hospital, Dermatology dpt.	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Dermtreat	Larix A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	Frequency and intensity of adverse events (AEs) and adverse device effects (ADEs) collected during the investigation	2 days
Secondary	Ability to apply patches correctly	Study staff reported observation on subject's ability to apply patches correctly	2 days
Secondary	Understanding of the Instructions for use leaflet	Subject reported outcome on the understanding of the Instructions for use leaflet	2 days
Secondary	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
Secondary	Optimising the design of the patch	Subject responses towards optimising the design of the patch	2 days