Vulvar Scarring Grading Scale for Lichen Sclerosus

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02880904
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 46.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• 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: Mar 1, 2016
• Actual Primary Completion Date: Jan 10, 2020
• Actual Study Completion Date: Jan 10, 2020

Outcome Measures

Primary Outcome Measures

1. Scarring severity grading scale for vulvar lichen sclerosus [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. [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Bethanee J Schlosser, MD, PhD, Northwestern University Feinberg School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT02880904
• Other Study ID Numbers: STU00202270
• First Posted: Aug 26, 2016
• Last Update Posted: Oct 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lichen Sclerosus et Atrophicus

Study Results

No Results Posted as of Oct 9, 2020