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

Lichen Sclerosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135402
• Other study ID #: Laser-Lichen
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: October 2023
• Source: Kantonsspital Winterthur KSW
• Contact: Rebecca R Zachariah, MD
• Phone: +41522663173
• Email: rebecca.zachariah[@]ksw.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus

Intervention

Device:
• Treatment with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide

Drug:
• Treatment with Clobetasol
Application of Clobetasol twice per week

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lichen Score Follow up	Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)	15 months
Secondary	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
Secondary	German Pelvic floor questionnaire	Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT	15 months