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Archives of Gynecology and Obstetrics

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Open Access 05-05-2023 | Lichen Sclerosus Et Atrophicus | Urogynecology

Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial

Authors: Volker Viereck, Marianne Gamper, Sigrid Regauer, Claudia Walser, Irena Zivanovic

Published in: Archives of Gynecology and Obstetrics | Issue 2/2023

Abstract

Purpose

Vulvar lichen sclerosus (LS) is a chronic debilitating inflammatory skin disease. Today, the gold standard is a life-long topical steroid treatment. Alternative options are highly desired. We present a study protocol of a prospective, randomized, active-controlled, investigator-initiated clinical trial comparing a novel non-invasive dual Nd:YAG/Er:YAG laser therapy with the gold standard for the management of LS.

Methods

We recruited 66 patients, 44 in the laser arm and 22 in the steroid arm. Patients with a physician-administered clinical LS score ≥ 4 were included. Participants received either four laser treatments 1–2 months apart, or 6 months of topical steroid application. Follow-ups were planned at 6, 12, and 24 months. The primary outcome looks at the efficacy of the laser treatment at the 6-month follow-up. Secondary outcomes look at comparisons between baseline and follow-ups within the laser or the steroid arm, and comparisons between laser vs. steroid arm. Objective (LS score, histopathology, photo documentation) and subjective (Vulvovaginal Symptoms Questionnaire, symptom VAS score, patient satisfaction) measurements, tolerability, and adverse events are evaluated.

Conclusion

The findings of this trial have the potential to offer a novel treatment option for LS. The standardized Nd:YAG/Er:YAG laser settings and the treatment regime are presented in this paper.

Clinical trial identification number

NCT03926299.

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Title: Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial
Authors: Volker Viereck
Marianne Gamper
Sigrid Regauer
Claudia Walser
Irena Zivanovic
Publication date: 05-05-2023
Publisher: Springer Berlin Heidelberg
Keywords: Lichen Sclerosus Et Atrophicus
Laser
Published in: Archives of Gynecology and Obstetrics / Issue 2/2023
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-023-07055-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial

Abstract

Purpose

Methods

Conclusion

Clinical trial identification number

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Conclusion

Clinical trial identification number

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