The use of the Laser for treatment of Sclerosus Lichen in the female external genitalia

Phase 3

Recruiting

• Conditions: Vulvar Sclerosus Lichen; Vulva Diseases; Clobetasol; C13.351.500.944; D04.210.500.908.093.250; C13.351.500.944.815

• Registration Number: RBR-4p9s5y
• Lead Sponsor: Hospital Universitário da Universidade Federal de Juiz de Fora - UFJF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women attended at the outpatient clinic of the Gynecology Service of the University Hospital of the Federal University of Juiz de Fora - UFJF, with genital atrophic lichen sclerosus diagnosed by histopathological evaluation of vulvar biopsy.

Exclusion Criteria

Women who have used or used other therapeutic methods for lichen in the last 30 days; women with differential diagnoses identified in the biopsy, such as vulvar intraepithelial neoplasia or vitiligo.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the results of the treatment of lichen sclerosus with Clobetasol and the treatment with laser therapy with regard to the perception of improvement of patients' quality of life and the vulvar anatomical manifestations of the disease. In the first case, the analysis will be performed by comparing the scores obtained in each domain in the application of the questionnaire. In the second case, the analysis will be performed by comparing the presence of clinical signs of the disease and the extent of vulvar involvement, being classified as absent, mild (less than 30% of the vulva), moderate (30 to 50% of the vulva) or severe (more than 50% of the vulva).

Secondary Outcome Measures

Name	Time	Method
To analyze the profile of women affected by lichen sclerosus regarding epidemiological aspects: current age, age of diagnosis, color, marital status, schooling, associated comorbidities, among others.<br>;To evaluate the degree of impairment of the quality of life of the patients studied through the evaluation of the score obtained in the questionnaire response.<br>;To describe the lesions and their evolution from the treatments used based on the observation of the genitalia during the physical examination and the evaluation of the photographs, comparing possible remissions of clinical signs, skin color and texture, for example.