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

University of South Alabama (USA)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Vulvar Lichen Sclerosus

Treatments: Drug: Topical steroid; Device: MonaLisa Touch

Study type: Interventional

Funder types: Other

Identifiers

NCT05243563

1731682-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21

Exclusion criteria

• prior vaginal mesh or pelvic radiation
• active genital infection
• Current or past gynecologic malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Fractionated CO2 laser plus topical steroids

Experimental group

Description:

3 laser treatments at 6 week intervals for 6 months by a single trained operator

Treatment:

Drug: Topical steroid

Device: MonaLisa Touch

topical steroids alone

Active Comparator group

Description:

self-applied topical steroid therapy using clobetasol propionate 0.05%

Treatment:

Drug: Topical steroid