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

Dermtreat

Status: Completed

Conditions: Vulvar Lichen Sclerosus

Treatments: Device: Rivelin® plain patches

Study type: Interventional

Funder types: Industry

Identifiers

NCT03686800

DT-001-R-002

Details and patient eligibility

About

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 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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Rivelin® plain patches

Experimental group

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.

Treatment:

Device: Rivelin® plain patches