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

NCT ID: NCT03686800

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2018-11-15

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.

Conditions

Vulvar Lichen Sclerosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rivelin® plain patches

Intervention Type: DEVICE

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

Interventions

Rivelin® plain patches

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Larix A/S

INDUSTRY

Sponsor Role: collaborator

Dermtreat

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregor B.E. Jemec, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital, Dermatology dpt.

Locations

Zealand University Hospital, Dermatology dpt.

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

DT-001-R-002

Identifier Type: -

Identifier Source: org_study_id