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Vulvar Scarring Grading Scale for Lichen Sclerosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02880904
Recruitment Status : Terminated (Investigator is no longer at Northwestern University)
First Posted : August 26, 2016
Last Update Posted : October 9, 2020
Information provided by (Responsible Party):
Stephanie Rangel, Northwestern University

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

Condition or disease Intervention/treatment
Lichen Sclerosus Lichen Sclerosus et Atrophicus Other: Photography

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus
Study Start Date : March 2016
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Intervention Details:
  • Other: Photography
    Photos will be taken of the vulvar lichen sclerosus lesions.

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female subjects from the Northwestern University Vulvar Mucosal Specialty Clinic, with histologically confirmed diagnosis of vulvar lichen sclerosus

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02880904

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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Bethanee J Schlosser, MD, PhD Northwestern University Feinberg School of Medicine
Publications of Results:
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Responsible Party: Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University Identifier: NCT02880904    
Other Study ID Numbers: STU00202270
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases