Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04107454
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2019-09-24
Brief Title:
Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Regular photo-documentation of the treated skin will demonstrate a potential change of the tissue
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 64 pulse energy 232 mJ fluenz 118Jcm2 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
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 64 pulse energy 232 mJ fluenz 118Jcm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None