NCT05243563

Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?

A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.

Detailed description

Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DEVICE	MonaLisa Touch	3 laser treatments at 6 week intervals for 6 months by a single trained operator
DRUG	Topical steroid	self-applied topical steroid therapy using clobetasol propionate 0.05%

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2022-02-17
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study