Evidence map›Paper›PMID 37145134›Full record

ArticleArchives of gynecology and obstetrics2023

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

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

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Archives of gynecology and obstetrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03926299 (Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03926299 nacompletednot on this map

Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream

TypeinterventionalSponsorProf. Dr. Volker ViereckRan2019 to 2024Enrolled66ConditionsChronic Skin Disease, Vulvar Lichen SclerosusArmsFotonaSmooth SP® Spectro laser device, Clobetasol propionate 0.05% ointment
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Update vulval dermatology - diagnostics and therapy.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Volker ViereckDepartment of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld Postfach, 8501, Frauenfeld, Switzerland. volker.viereck@stgag.ch.ORCID http://orcid.org/0000-0002-1116-8912
Marianne GamperDepartment of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld Postfach, 8501, Frauenfeld, Switzerland.ORCID http://orcid.org/0000-0002-8235-1239
Sigrid RegauerInstitute of Pathology, Medical University Graz, Graz, Austria.ORCID http://orcid.org/0000-0002-7077-578X
Claudia WalserDepartment of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld Postfach, 8501, Frauenfeld, Switzerland.
Irena ZivanovicDepartment of Gynecology and Obstetrics, Cantonal Hospital Frauenfeld Postfach, 8501, Frauenfeld, Switzerland.
Kantonsspital Frauenfeld · CHMedical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeVulvar 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.

methodsWe 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.

conclusionThe 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.

Indexed as

Lasers, Solid-StateVulvar Lichen SclerosusFemaleHumansPatient SatisfactionProspective StudiesRandomized Controlled Trials as TopicSteroidsTreatment OutcomeSteroidsErbium:YAG laserGold standardNeodymium:YAG laserPhysician-administered clinical lichen sclerosus scoreRCT

Identifiers

PMID37145134
PMCPMC10293446
OpenAlexW4372337608

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.