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

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ClinicalTrials.gov Identifier: NCT04107454
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Deka Medical, Inc.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Lichen Sclerosus Et Atrophicus of the Vulva Device: Active microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence Device: Sham microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is designed as a randomized placebo-controlled study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study enrollment possible for all participants with vulvar lichen sclerosus
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107454


Contacts
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Contact: Stephanie Neumann, Dr. med. +41 031 632 10 10 stephanie.neumann@insel.ch

Locations
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Switzerland
Inselspital Frauenklinik Recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Deka Medical, Inc.
Investigators
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Principal Investigator: Laura Knabben, Dr. med. Inselspital Frauenklinik
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04107454    
Other Study ID Numbers: VLS-AFCL
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University Hospital Inselspital, Berne:
Lichen sclerosus
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases