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Developing a checklist to allow accurate diagnosis of vulval lichen sclerosus

Establishing effective diagnostic criteria for vulval lichen sclerosus: a diagnostic test accuracy study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN76946205
Enrollment
407
Registered
2024-06-17
Start date
2024-09-27
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulval lichen sclerosus Skin and Connective Tissue Diseases

Interventions

407 consecutive women (=18 years of age) who have been referred to a skin specialist by their GP with a vulval skin complaint will be identified by the usual care team from clinic lists. Patients will

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Female 2. >=18 years of age 3. New presentation to a specialist clinic (secondary care or community hub) with a vulval skin complaint

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva 3. More than 2 weeks since initial consultation from managing clinician

Design outcomes

Primary

MeasureTime frame
To test a list of 17 expert-agreed diagnostic criteria measured using vulval clinical examination at one timepoint during a clinical consultation, to establish the best predictors for vulval lichen sclerosus and subsequently develop a diagnostic tool

Secondary

MeasureTime frame
Development of training resources/manual using qualitative methods, including input from patients and health professionals, to support the use of a future diagnostic tool at the end of the data collection

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactRheanne Leatherland
shells@nottingham.ac.ukNone provided

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026