NCT06135402

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	Treatment with Monalisa Glide Laser	3 fractional laser treatment-sessions with Monalisa Glide
DRUG	Treatment with Clobetasol	Application of Clobetasol twice per week

Timeline

• Start date: 2023-11-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2023-11-18
• Last updated: 2025-09-23

Locations

1 site across 1 country: Switzerland