Clinical Trial: Vulvar Scarring Grading Scale for Lichen Sclerosus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus

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

Detailed Summary: 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.
Sponsor: Northwestern University

Current Primary Outcome: Scarring severity grading scale for vulvar lichen sclerosus [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 4, 2016
Date Started: March 2016
Date Completion: May 2017
Last Updated: August 23, 2016
Last Verified: August 2016