Vulvar Scarring Grading Scale for Lichen Sclerosus

Terminated

• Conditions: Lichen Sclerosus et Atrophicus; Lichen Sclerosus

• Registration Number: NCT02880904
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scarring severity grading scale for vulvar lichen sclerosus	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States