Vulvar Scarring Grading Scale for Lichen Sclerosus

NCT02880904 | Terminated

• 1 other identifier: STU00202270
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lichen Sclerosus; Lichen Sclerosus et Atrophicus

Outcome Measures

Primary Outcomes (1)

• Scarring severity grading scale for vulvar lichen sclerosus

  one year

Secondary Outcomes (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

Interventions

Photography OTHER

Photos will be taken of the vulvar lichen sclerosus lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female subjects from the Northwestern University Vulvar Mucosal Specialty Clinic, with histologically confirmed diagnosis of vulvar lichen sclerosus

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Hansen A, Carr K, Jensen JT. Characteristics and initial diagnoses in women presenting to a referral center for vulvovaginal disorders in 1996-2000. J Reprod Med. 2002 Oct;47(10):854-60.

  PMID: 12418071 RESULT

• Gokdemir G, Baksu B, Baksu A, Davas I, Koslu A. Features of patients with vulvar dermatoses in dermatologic and gynecologic practice in Turkey: is there a need for an interdisciplinary approach? J Obstet Gynaecol Res. 2005 Oct;31(5):427-31. doi: 10.1111/j.1447-0756.2005.00314.x.

  PMID: 16176512 RESULT

• McPherson T, Cooper S. Vulval lichen sclerosus and lichen planus. Dermatol Ther. 2010 Sep-Oct;23(5):523-32. doi: 10.1111/j.1529-8019.2010.01355.x.

  PMID: 20868406 RESULT

• Goldstein AT, Marinoff SC, Christopher K, Srodon M. Prevalence of vulvar lichen sclerosus in a general gynecology practice. J Reprod Med. 2005 Jul;50(7):477-80.

  PMID: 16130842 RESULT

• Schlosser BJ, Mirowski GW. Lichen sclerosus and lichen planus in women and girls. Clin Obstet Gynecol. 2015 Mar;58(1):125-42. doi: 10.1097/GRF.0000000000000090.

  PMID: 25608255 RESULT

• Bradford J, Fischer G. Long-term management of vulval lichen sclerosus in adult women. Aust N Z J Obstet Gynaecol. 2010 Apr;50(2):148-52. doi: 10.1111/j.1479-828X.2010.01142.x.

  PMID: 20522071 RESULT

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

Photography

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bethanee J Schlosser, MD, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Dermatology

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: August 26, 2016
• Study Start: March 1, 2016
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)