Evidence map›Paper›PMID 39355724›Full record

ArticleSkin health and disease2024

A systematic review of outcome measures evaluating treatment efficacy in vulval lichen sclerosus and evaluation of patients' priorities.

Sara Jasionowska, Aurora Almadori, Mary Goble, Benjamin J Langridge, Despoina Iakovou, Fady Kamel, Milla McKenzie, Allan Mclean, Deborah Boyle, Nicole Zenner and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Skin health and disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07352917 (A Prospective Phase II Open-Label Pilot Study Evaluating the Efficacy and Safety of Methotrexate in the Treatment of Severe Vulvar Lichen Sclerosus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT07352917 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Prospective Phase II Open-Label Pilot Study Evaluating the Efficacy and Safety of Methotrexate in the Treatment of Severe Vulvar Lichen Sclerosus

TypeinterventionalSponsorClinica Dermatologica Arbache ltdaRan2026 to 2027Enrolled12ConditionsVulvar Lichen SclerosusArmsMethotrexate (MTX)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Living with lichen sclerosus: A narrative of transformation, advocacy and community building.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Sara JasionowskaCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.ORCID https://orcid.org/0000-0001-7703-2084
Aurora AlmadoriCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.ORCID https://orcid.org/0000-0001-8783-3192
Mary GobleCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.
Benjamin J LangridgeCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.
Despoina IakovouCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.
Fady KamelCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.
Milla McKenzieCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.
Allan McleanDepartment of Obstetrics and Gynaecology Royal Free London NHS Foundation Trust Hospital London UK.
Deborah BoyleDepartment of Obstetrics and Gynaecology Royal Free London NHS Foundation Trust Hospital London UK.
Nicole ZennerDepartment of Obstetrics and Gynaecology Royal Free London NHS Foundation Trust Hospital London UK.
Victoria SwaleDepartment of Dermatology Royal Free London NHS Foundation Trust Hospital London UK.
Peter E M ButlerCharles Wolfson Centre for Reconstructive Surgery Royal Free Hospital London UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vulval lichen sclerosus (VLS) is an inflammatory skin disease characterised by itching, apareunia, loss of vulval architecture and scarring. Heterogeneity in outcome reporting precludes comparison between treatments. This study aimed to systematically review outcome measures used to evaluate the efficacy of VLS treatments and present patients' treatment priorities. This review followed the PRISMA guidelines using a registered protocol (PROSPERO: CRD42022356738). Multiple databases were searched, along with grey literature on Clinicaltrials.gov, European Union Clinical Trials and International Standard Randomised controlled trial (RCT) registries. All RCTs assessing any treatment for VLS were eligible for inclusion. A total of 775 patients were assessed across 21 RCTs. The assessment tools reported outcomes in the following domains: patient-reported symptoms assessed with one validated scale in 12 studies and seven non-validated scales in nine studies; sexual function with validated female sexual function index and female sexual distress scale in two studies and two non-validated scales in two studies; quality of life with three validated scales in three studies and clinician-reported objective outcomes with two validated scales in three studies and six non-validated scales in fourteen studies. Histological changes were assessed in 10 studies and tissue biomechanics in one study. We also carried out an online survey completed by 809 women with VLS to assess their research and disease treatment priorities and identified validated outcome measures to assess these. There is high variability in assessing treatment outcomes for VLS. We identified validated assessment tools which could be implemented in VLS studies to evaluate the effectiveness of treatments.

Identifiers

PMID39355724
PMCPMC11442075

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.