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Laser Therapy in Women With Lichenoid Disorders — Liser  

Lichen Planus Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04697563
Study type Interventional
Source Medical University of Graz
Contact
Status Recruiting
Phase N/A
Start date November 17, 2020
Completion date December 31, 2023
View Details
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