NCT04697563

Laser Therapy in Women With Lichenoid Disorders

Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.

Detailed description

Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both can cause vulvar itching, burning and pain and can lead to urinary and sexual dysfunction. Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an effective treatment option. Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women with lichenoid disorders. Design: Randomized double-blinded placebo- controlled clinical study Study Population: Women diagnosed with LD will be recruited from a specialized University outpatient clinic. Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus ongoing therapy Sample size Total 40 patients Primary study outcome: Visual analogue scale (VAS) composite score in regard to LD Secondary study outcomes: quality of life (QoL) (Skindex questionnaire); Treatment discomfort/ pain (VAS); Patient treatment satisfaction (Questionnaire to ask for treatment satifsaction: ZUF-8); Subjective improvement (Patient global impression of improvement- PGI-I), clinical LS score, histological appearance

Conditions

• Lichen Sclerosus Et Atrophicus
• Lichen Planus

Interventions

Type	Name	Description
DEVICE	Laser	real laser beam administered
DEVICE	Placebolaser	no laser beam admitted

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-06-13
• Completion: 2024-06-13
• First posted: 2021-01-06
• Last updated: 2025-05-13

Locations

1 site across 1 country: Austria