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

NCT06135402 | Recruiting

• 1 other identifier: Laser-Lichen
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Lichen Score Follow up

  15 months

• Vulva assessment Scale

  15 months

• German Pelvic floor questionnaire

  15 months

Study Arms (2)

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

Treatment with Monalisa Glide Laser DEVICE

3 fractional laser treatment-sessions with Monalisa Glide

Laser group

Treatment with Clobetasol DRUG

Application of Clobetasol twice per week

Clobetasol group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

Therapeutics; Clobetasol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gesine Meili, MD

  Clinic of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca R Zachariah, MD

CONTACT

+41522663173; rebecca.zachariah@ksw.ch

Susanne Forst

CONTACT

+41522663387; susanne.forst@ksw.ch

Study Design

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

Model Details: Monocentric, prospective, randomized, single-blinded, active-controlled

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 18, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)