Vulvar lichen sclerosus
Conditions
Interventions
Approximately 10 participants will initially undergo a gynecological clinical evaluation and biopsy of the area(s) of lichen sclerosus with the greatest alteration, before starting the proposed treatm
Sponsors
Universidade Federal de São Paulo (UNIFESP)
Universidade Federal de São Paulo (UNIFESP)
Eligibility
Sex/Gender
Female
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients aged 45 to 85 years; clinical diagnosis of vulvar lichen sclerosus; treatment-naïve or refractory to high-potency corticosteroid therapy.
Exclusion criteria
Exclusion criteria: Absence of the characteristic hyalinized band in the dermis superficial to histology in the first biopsy performed; association with neoplasms in the stratum corneum; genital infectious or inflammatory comorbidities at the time of recruitment; hx of vulvar radiotherapy; collagenoses or other autoimmune diseases involving connective tissue; immunosuppression or use of systemic immunosuppressive drugs; gynecological surgeries in a period of less than 6 months; and whether they were treated with topical corticosteroid therapy, pimecrolimus, tacrolimus, or any other topical therapy known or suspected to have an effect on vulvar lichen sclerosus or its symptoms in the 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and histological improvement of patients with vulvar lichen sclerosus undergoing therapy with microablative and fractional CO2 laser. Clinical improvement will be verified by physical examination (with no signs of disease activity) and by visual analogue scale of symptoms (with a reduction in the score for each symptom), while histological and immunohistochemical improvement will be documented by normalization of the thickness. of the epithelium, by the appearance of elastic fibers and normalization of the expression of extracellular matrix protein 1 (ECM-1), and by the reduction of the levels of collagen types I, III and V. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the quality of life of patients 30 days after the end of the therapeutic regimen with microablative and fractional CO2 laser, evaluated by the Skindex-29 questionnaire. | — |
Countries
Brazil
Contacts
Public ContactDayane Cavalheiro
Universidade Federal de São Paulo (UNIFESP)
Outcome results
None listed