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

NCT04107454 | Unknown DMC

• 1 other identifier: VLS-AFCL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus Et Atrophicus of the Vulva

Keywords

Lichen sclerosus

Outcome Measures

Primary Outcomes (1)

• Vulvar pain measured with the visual analog scale with a range from 0 (no pain, best Outcome) to 10(worst pain, worst Outcome)

  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 Outcomes (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))

  End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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

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.

Active group

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

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study enrollment possible for all participants with vulvar lichen sclerosus
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Deka Medical, Inc.: collaborator

Study Sites (1)

Inselspital Frauenklinik

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Knabben, Dr. med.

  Inselspital Frauenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a randomized placebo-controlled study

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: January 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)