Vulvar Scarring Grading Scale for Lichen Sclerosus
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ClinicalTrials.gov Identifier: NCT02880904
Recruitment Status :
(Investigator is no longer at Northwestern University)
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).
Condition or disease
Lichen SclerosusLichen Sclerosus et Atrophicus
Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.
Scarring severity grading scale for vulvar lichen sclerosus [ Time Frame: one year ]
Secondary Outcome Measures :
Correlation of severity of vulvar LS scarring, as documented at time of clinical examination and compared to scores on the LS grading scale, with the patient quality of life at the time of examination. [ Time Frame: one year ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female subjects from the Northwestern University Vulvar Mucosal Specialty Clinic, with histologically confirmed diagnosis of vulvar lichen sclerosus
Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination.
Patients with histologically confirmed vulvar LS.
Patients who refuse complete mucocutaneous examination.
Patients who refuse recommended diagnostic procedures.