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Developing a checklist to allow accurate diagnosis of vulval lichen sclerosus

Not Applicable
Conditions
Vulval lichen sclerosus
Skin and Connective Tissue Diseases
Registration Number
ISRCTN76946205
Lead Sponsor
niversity of Nottingham
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
Female
Target Recruitment
407
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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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