Vulvar Scarring Grading Scale for Lichen Sclerosus

Lichen Sclerosus Clinical Trial

Official title:

Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02880904
• Other study ID #: STU00202270
• Status: Terminated
• Start date: March 2016
• Est. completion date: January 10, 2020

Study information

• Verified date: October 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scarring severity grading scale for vulvar lichen sclerosus		one year
Secondary	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