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

August 18, 2021 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lichen sclerosus (LS) is a vulvar dermatosis that changes the skin to white plaques (lichenification), less elasticity (sclerosis) and the tissue shows contractions with erosions and fissures. Gold standard for the therapy of LS is the topical application of ultrapotent corticosteroids, proper treatment reverses the underlying inflammation of LS, reduces symptoms as itching and burning and may lower the risk of getting vulvar cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system. Treatment with the fractional microablative carbodioxide Laser is a minimal invasive procedure. In the literature only few published reliable data in laser therapy of vulvar skin diseases can be found, there is only one survey especially for the treatment of vulvar LS. However, published data show a potential that justifies the use of this method for the indication in treating LS.

Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. But there is little comparable data, so the necessary frequency of treatment, the dose of laser application, additional use of corticosteroid or the sustainability is not yet known

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.

Primary endpoint will be the outcome after laser application, the change in symptoms between both groups. As secondary endpoint it is important to see, weather sexual functions will be influenced in this therapy.

The study is designed as a randomized placebo-controlled study.

Inclusion criteria: All patients are treated in the dysplasia unit of the university gynecological hospital of Bern. They have a histological confirmation of LS or a clinical diagnosis of LS according to the lichen-score. Informed consent will be oral and written. The minimum age is 18 years

Exclusion criteria: Pregnancy, local bacterial or parasitical infection, others severe dermatosis, Lichen-score < 5, vulvar cancer

All women who qualify for the study and signed informed consent will be grouped by computer-controlled randomization. All of them are informed, that they have to take part in three sequent sessions of treatment in the interval of three weeks and the defined follow -ups after six and twelve weeks.

The session starts with the application of an ointment for a local anesthesia in the vulvar region. Meanwhile they will answer the questionnaires (VAS for recording the vulvar symptoms, FSFI for the documentation of the sexual function, another questionnaire to evaluate the present situation).

After about 20 minutes the gynecologist will start the examination with a photo documentation of the vulva, then the laser application of the vulva is following. After the treatment a cream of silversulfadiazine (Flammazine) will be applied.

All personal data of the patients will be anonymized. The study specific intervention is an application of laser radiation on the vulvar skin.

The used laser instrument for this specific intervention is a microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence. For the vulvar use the Hi-Scan V2LR scanning system has to be connected.

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.

Projected are three sequent sessions in three weeks intervals. Application time takes approximately five minutes for the whole vulvar skin.

The study will compare two groups of patients, both fulfil the same criteria as a histological confirmation of LS or a clinical diagnosis of LS according to the lichen-score. They will be grouped by computer-controlled randomization in an active group and in a placebo group.

The active group will be treated by radiation with a real dose: power 24 W, exposure time 400 microsec, DOT spacing 1000.

The placebo group will be treated with a sham dose: power 0, 5 W, exposure time 400 microsec, DOT spacing 1000.

Both groups undergo the same procedures, they will have the same application time and application area. Except of the different radiation dose they undergo the same regimen.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Frauenklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged >18 years
  • Women with histological assured or clinical confirmed Lichen sclerosus (Lichen score > 5)
  • Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

  • Unable to read or understand study patient information document
  • Patients with a legal guardian
  • Refusal to participate
  • Missing signed consent
  • Pregnancy and lactation
  • Proven bacterial or parasitic infection (clinical examination and/or vaginal wet mount)
  • Vulvar cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active group
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: 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.
Placebo Comparator: Placebo group
Laser setting is a sham dose:power 0, 5 W, exposure time 400 microsec, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvar pain measured with the visual analog scale with a range from 0 (no pain, best Outcome) to 10(worst pain, worst Outcome)
Time Frame: End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks
Primary objective of this study is the number of patients with reduction or cure of the symptoms of LS as itching, burning and vulvar pain after treatment is reduced. The effect will be measured with the visual analog scale.
End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual functioning measured with the Female Sexual Function Index (FSFI), each question ranges from 0 to 5 and the full scale score will be calculated(ranges from 2 (worst Outcome) to 36 (best Outcome))
Time Frame: End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks
Secondary objective is the awareness that the laser treatment leads to an improvement of the sexual function, e.g. amelioration the dyspareunia.he effect will be measured with the Questionaire FSFI.
End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Deka Medical, Inc.

Investigators

  • Principal Investigator: Laura Knabben, Dr. med., Inselspital Frauenklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLS-AFCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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