Comparison of Laser Treatment With Clobetasol Therapy in... | NCT06135402

Studies
Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

NCT06135402

Sponsor

Kantonsspital Winterthur KSW

Status

Recruiting

Last Update Posted

Sep 23, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Lichen Sclerosus

Interventions

Treatment with Monalisa Glide Laser
Treatment with Clobetasol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2023Actual

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Nov 1, 2027Estimated

First Submitted Date

Oct 24, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2025

Last Update Posted Date

Sep 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

Detailed Description

Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser group	Experimental	3 monthly fractional laser treatment according to the user manual (correct applicator, vulvar and vaginal preset). In between daily local skin care with a drug free product of patients' choice.	Device: Treatment with Monalisa Glide Laser
Clobetasol group	Active Comparator	Maintenance treatment with vulvar TCS (clobetasol) application 2x/week. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice.	Drug: Treatment with Clobetasol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment with Monalisa Glide Laser	Device	3 fractional laser treatment-sessions with Monalisa Glide	Laser group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lichen Score	The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT	3 months

Secondary Outcomes

Measure	Description	Time Frame
Lichen Score Follow up	Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)	15 months
Vulva assessment Scale	Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pre- or postmenopausal
12 weeks of continuous topical clobetasol treatment completed.
Written informed consent
German speaking (Study information and IC available only in German)

Exclusion Criteria:

Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use
Contraindication for the use of topic clobetasol
History of vulva laser
Immune-suppression
Pregnancy or planned pregnancy, breast feeding.
Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.
History of vulvar or pelvic radiation therapy
Uncertain vulvar findings, which require a biopsy.
Acute vulvitis, especially recurrent genital herpes
History of vaginal mesh implantation within 6 months preceding this study
Known or suspected non-compliance, drug or alcohol abuse
Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
Previous enrolment into the current investigation
Enrolment of the PI, his/her family members, employees and other dependent persons

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rebecca R Zachariah, MD	Contact	+41522663173		rebecca.zachariah@ksw.ch
Susanne Forst	Contact	+41522663387		susanne.forst@ksw.ch

Overall Officials

Name	Affiliation	Role
Gesine Meili, MD	Clinic of obstetrics and gynecology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Winterthur	Recruiting	Winterthur	Canton of Zurich	8401	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018459	Lichen Sclerosus et Atrophicus

Ancestor Terms

ID	Term
D017512	Lichenoid Eruptions
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001623	Betamethasone
D013259	Steroids, Fluorinated
D013256	Steroids
D000072473	Fused-Ring Compounds

ID	Term
D013812	Therapeutics
D002990	Clobetasol