MedTrace Logo

Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis

NCT04107454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-08-19

No results posted yet for this study

Summary

Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. As measured by visual analogue scale (VAS) symptoms as itching, burning, pain will be determined six weeks after the last laser treatment. Secondary endpoints will be sexual function measured with the female sexual function index (FSFI) and the vulvar skin changes measured by the Lichen score (LS).

Regular photo-documentation of the treated skin will demonstrate a potential change of the tissue.

Conditions

  • Lichen Sclerosus Et Atrophicus of the Vulva

Interventions

DEVICE

Active microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence

Active application of laser radiation on the vulvar skin. The laser setting is: Power 24 W, exposure time 400 microsec, density 6,4 %, pulse energy 23,2 mJ, fluenz 1,18J/cm2, emission mode DP, DOZ Dwell 400, DOT spacing 1000.

DEVICE

Sham microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence

Sham application of laser radiation on the vulvar skin. Laser setting is a sham dose:power 0, 5 W, exposure time 400 microsec, DOT spacing 1000

Sponsors & Collaborators

  • Deka Medical, Inc.

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Laura Knabben, Dr. med. · Inselspital Frauenklinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107454 on ClinicalTrials.gov