NCT03686800

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

September 24, 2018

Last Update Submit

March 15, 2019

Conditions

Vulvar Lichen Sclerosus

Keywords

VLS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Adverse Events

    2 days

  • Ability to apply patches correctly

    2 days

  • Understanding of the Instructions for use leaflet

    2 days

  • Visual analogue scale (VAS) scores

    2 days

  • Optimising the design of the patch

    2 days

Study Arms (1)

Rivelin® plain patches

EXPERIMENTAL

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

Interventions

Rivelin® plain patchesDEVICE

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

Rivelin® plain patches

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women (≥ 18 years) diagnosed with VLS
  • Has received written and oral study information
  • Has given her written consent to study participation

You may not qualify if:

  • Pregnant
  • Menstruating at the time of patch application
  • Unable to communicate clearly with the examining doctors
  • Under the guardianship of another person or institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital, Dermatology dpt.

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gregor B.E. Jemec, MD

    Zealand University Hospital, Dermatology dpt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 27, 2018

Study Start

September 25, 2018

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

DK(1)