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

Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus

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.

Study Overview

• Status: Recruiting
• Conditions: Lichen Sclerosus
• Intervention / Treatment: Device: Treatment with Monalisa Glide Laser; Drug: Treatment with Clobetasol

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca R Zachariah, MD; Phone Number: +41522663173; Email: rebecca.zachariah@ksw.ch
• Study Contact Backup: Name: Susanne Forst; Phone Number: +41522663387; Email: susanne.forst@ksw.ch

Study Locations

• Switzerland
  • Zürich
    • Winterthur, Zürich, Switzerland, 8401
      • Recruiting
      • Kantonsspital Winterthur
      • Contact: Rebecca Zachariah, MD; Phone Number: +41522663173; Email: rebecca.zachariah@ksw.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; 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; 3 fractional laser treatment-sessions with Monalisa Glide
Active Comparator: Clobetasol group; 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; Application of Clobetasol twice per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	15 months
German Pelvic floor questionnaire	Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT	15 months

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Investigators: Principal Investigator: Gesine Meili, MD, Clinic of obstetrics and gynecology

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: Laser-Lichen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No