vulvar lichen sclerosus - response of treatments
Conditions
Interventions
women with clinical suspicion of vulvar lichen sclerosus will be submitted to a biopsy of the vulvar skin to confirmation. The pilot study predicts 10 women in each group. Ten of them will receive the
Sponsors
Faculdade de Medicina da Universidade Federal do Rio Grande do Sul
Fundo de Incentivo à Pesquisa do Hospital de Clínicas de Porto Alegre
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: women with clinical suspicion of vulvar lichen sclerosus, whose diagnosis is confirmed by biopsy, wich accept to participate in the study and sign the term of consent
Exclusion criteria
Exclusion criteria: vulva cancer at inicial biopsy, diagnosis other than lichen sclerosus in the inicial biopsy, current treatment with topical steroid in the vulva, transplanted, pregnant or lactating women and hiv carriers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anatomophatological modification of the biopsy of the vulva before and 30 days after the end of the treatment. The findings expected are increased ephitelial maturation, improvement of the organization of the basal layer, mucosal thickening, enlarged granular layer, neocolagenesis, increased number of fibroblasts, increased stromal density and reduction of the inflammatory process. Because there are not studies about radiofrequency in the treatment of vulvar lichen sclerosus, later statistical analysis will assess its effectiveness, with statistical significance set at 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| assessment of the impact of the disease oh sexuality before and after treatment, through the Female Sexual Function Index (FSFI) form. Later statistical analysis will assess its effectiveness, with statistical significance set at 5%.;evaluation of itchy, painful or vulvar discomfort and difficulty in vaginal penetration before, during and after treatment. A visual pain scale, graded from zero to ten and with color variation from each symptom at each visit will be used. Because there are not studies about radiofrequency in the treatment of vulvar lichen sclerosus, later statistical analysis will assess its effectiveness, with statistical significance set at 5%. | — |
Countries
Brazil
Contacts
Public Contactrodrigo balbinotti
Universidade Federal do Rio Grande do Sul
Outcome results
None listed