Vulvar Lichen Sclerosus: Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniela de Fátima Teixeira da Silva
• Collaborator: Hospital Perola Byington
• Treatments: Clobetasol

Criteria

Inclusion Criteria:

• adult female patients (aged over 18 years);

• vulvar lichen sclerosus diagnosed histologically;

• normal level of cortisol confirmed by blood test.

Exclusion Criteria:

• adult female patients under the age of 18;

• patients with any kind of ongoing cancer and/or AIDS or coagulopathy, pregnant or breastfeeding women;

• patients using corticosteroids, immunosuppressants or anticoagulants;

• patients with renal, hepatic or pulmonary-cardiovascular failure;

• patients who have undergone any kind of organ transplantation in the last three years.