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Vulvar Scarring Grading Scale for Lichen Sclerosus

Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02880904
Enrollment
30
Registered
2016-08-26
Start date
2016-03-31
Completion date
2020-01-10
Last updated
2020-10-09

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

Conditions

Lichen Sclerosus, Lichen Sclerosus et Atrophicus

Brief summary

The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).

Detailed description

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.

Interventions

Photos will be taken of the vulvar lichen sclerosus lesions.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients who refuse complete mucocutaneous examination. * Patients who refuse recommended diagnostic procedures. * Pregnant women or prisoners.

Design outcomes

Primary

MeasureTime frame
Scarring severity grading scale for vulvar lichen sclerosusone year

Secondary

MeasureTime frame
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.one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026