Vulvar Lichen Sclerosus: Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser
Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can
cause intense itching as well stenosis, hindering the evacuation and urination. It can also
limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual
intercourse). The standard treatment for this disease is the use of topical corticosteroids
to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic
therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent
and low-level laser therapy (LLLT) are therapies that can promote effective immunomodulatory
responses at the application site by means of photophysical and photochemical phenomena from
the molecular to the systemic level, which promote their use in chronic dermatoses. The aim
is to study and compare the effects of PDT, LLLT, and topical corticosteroid in VLS
evaluating clinical, histological, immunohistochemical and spectroscopic responses. The study
will be prospective, randomized, and controlled, in a population of 60 women with
histological diagnoses of VLS, enrolled on the outpatient clinic of Genitoscopy Department of
the Pérola Byington Hospital in São Paulo. There will be 3 treatments groups: PDT, LLLT and
topical corticosteroid, where will be allocated by randomization 20 patients in each one. The
clinical course will be monitored by measuring local temperature, itching, clamping
(atrophy), and the appearance of the lesion. Histologically, the slides will be classified
according to the Hewitt grading and will have the ordering of collagen fibers quantified.
Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1, p53
and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance. Descriptive and
inferential statistical analyses will be conducted to compare the groups and for associations
between different responses.