Therapeutic comparison between treatments for Vulvar Lichen Sclerosus: study protocol of a randomized prospective and controlled trial.

BACKGROUND: 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 photobiomodulation (PBM) 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 compare the effects of PDT, PBM, and topical corticosteroid in VLS evaluating clinical, histological, immunohistochemical and spectroscopic responses. METHODS: The study is prospective, randomized and controlled, in a population of 60 women with histological diagnoses of VLS. There will be 3 treatments groups: PDT, PBM and topical corticosteroid (control group), where will be allocated by randomization 20 patients in each one. The clinical course will be monitored by measuring local temperature, itching, atrophy, and the area of the lesion. Histologically, the slides will be classified and will have the ordering of collagen fibers quantified. Immunohistochemical analysis will be done using the markers IFN-γ, TGF-ß, 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 make associations between different responses. The study is an open-label for patients with active symptomatic disease with a period of 1 year follow-up to determine the rate of recurrence in each groups. DISCUSSION: The immunological effects of PDT and PBM are described by several authors in inflammatory skin diseases, stimulating the production and organization of the associated collagen. Thus, it is reasonable to determine the efficacy and safety of these new treatments in VLS, in comparison to the control group, analyzing the recurrence time, the impact on the optical properties of the skin, and the benefit to patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02416531 .

Experimental burns: Comparison between silver sulfadiazine and photobiomodulation.

OBJECTIVE: To analyze morphological characteristics and organization of the collagen fibers of third degree burns from scalding compared to laser therapy and silver sulfadiazine, the latter considered as the gold standard. METHOD: Were selected 12 animals (Rattus norvegicus) also divided into three groups (control group [CG] - untreated burns; sulfadiazine group [SG] - burns were treated with silver sulfadiazine at 1%; laser group [LG] - burns were treated with photobiomodulation). The scald burns were carried out by using PVC mold, and the material collected on the 14th day after burn was prepared for morphological and optical retardation analysis for evaluation of inflammatory infiltrates and collagen organization, respectively. RESULTS: On the 14th day, the laser and sulfadiazine groups had mild inflammatory response, while the control group showed an intense inflammatory process, with statistical significance between laser and control groups, but not between sulfadiazine and control groups. Laser and sulfadiazine groups no longer had granulation tissue, opposite to what was seen in the control group. The presence of hair follicles and ulcer did not significantly differ between groups. The optical retardation of collagen fibers was higher in sulfadiazine group, followed by laser and control groups. As for systemic effect, we were able to identify it by simply analyzing the presence or absence of granulation tissue. CONCLUSION: Morphologically, the laser or silver sulfadiazine treatments were similar and both provided better organization of collagen fibers in relation to the untreated group. However, the sulfadiazine group modulated the deposition of collagen fibers more efficiently than the laser group.

Experimental burns: Comparison between silver sulfadiazine and photobiomodulation / Queimadura experimental: comparativo entre sulfadiazina de prata e fotobiomodulação

Summary Objective: To analyze morphological characteristics and organization of the collagen fibers of third degree burns from scalding compared to laser therapy and silver sulfadiazine, the latter considered as the gold standard. Method: Were selected 12 animals (Rattus norvegicus) also divided into three groups (control group [CG] - untreated burns; sulfadiazine group [SG] - burns were treated with silver sulfadiazine at 1%; laser group [LG] - burns were treated with photobiomodulation). The scald burns were carried out by using PVC mold, and the material collected on the 14th day after burn was prepared for morphological and optical retardation analysis for evaluation of inflammatory infiltrates and collagen organization, respectively. Results: On the 14th day, the laser and sulfadiazine groups had mild inflammatory response, while the control group showed an intense inflammatory process, with statistical significance between laser and control groups, but not between sulfadiazine and control groups. Laser and sulfadiazine groups no longer had granulation tissue, opposite to what was seen in the control group. The presence of hair follicles and ulcer did not significantly differ between groups. The optical retardation of collagen fibers was higher in sulfadiazine group, followed by laser and control groups. As for systemic effect, we were able to identify it by simply analyzing the presence or absence of granulation tissue. Conclusion: Morphologically, the laser or silver sulfadiazine treatments were similar and both provided better organization of collagen fibers in relation to the untreated group. However, the sulfadiazine group modulated the deposition of collagen fibers more efficiently than the laser group.

Resumo Objetivo: Analisar características morfológicas e organização das fibras colágenas de queimaduras de terceiro grau provocadas por escaldo em relação à terapia com laser e àquela considerada padrão-ouro, a sulfadiazina de prata. Método: Foram selecionados 12 animais (Rattus norvegicus), divididos igualmente em três grupos (grupo controle [GC] - queimaduras não tratadas; grupo sulfadiazina [GS] - queimaduras tratadas com sulfadiazina de prata 1%; grupo laser [GL] - queimaduras tratadas com fotobiomodulação). As queimaduras foram realizadas por escaldo com a utilização de molde de PVC, e o material coletado no 14º dia pós-queimadura foi preparado para análise morfológica e de retardo óptico, para avaliação do infiltrado inflamatório e da organização do colágeno, respectivamente. Resultados: No 14º dia, os grupos laser e sulfadiazina apresentaram resposta inflamatória leve, enquanto o grupo controle apresentou processo inflamatório intenso, havendo significância estatística entre os grupos laser e controle, mas não entre os grupos sulfadiazina e controle. Enquanto os grupos laser e sulfadiazina não apresentavam mais tecido de granulação, o grupo controle ainda apresentava. A presença de folículo piloso e de úlcera não diferiu significantemente entre os grupos. O retardo óptico das fibras colágenas foi maior no grupo sulfadiazina, seguido dos grupos laser e controle. Apenas a análise da presença ou ausência de tecido de granulação permitiu identificar o efeito sistêmico. Conclusão: Morfologicamente, os tratamentos com laser ou sulfadiazina de prata foram similares e ambos proporcionaram maior organização das fibras colágenas em relação ao grupo não tratado. Entretanto, o grupo sulfadiazina modulou a deposição das fibras colágenas mais eficientemente que o grupo laser.

Citologia endocervical (CE) e curetagem endocervical (CEE) como métodos preditivos da presença de lesöes de alto grau residuais nas margens de conizaçöes por cirurgia de alta frequência (CAF) / Endocervical cytology (EC) and curettage (ECC) as prediction methods of high-grade lesions marginal extension on loop electrosurgical excision procedures (LEEP) results

Objetivo: este estudo objetiva avaliar a eficácia da CE e da CEE após o cone-CAF como preditores do compromentimento lesional das margens do cone. Métodos: O CAF foi realizado sob anestesia local e visäo colposcópia dirta em 35 pacientes encaminhadas por resultados alterados na citologia e/ou biópsia. As CE/CEE foram coletadas imediatamente após o CAF, utilizando-se Cytobrush e cureta de Novak, respectivamente. Resultados: foram observadas lesöes de alto grau em 25/35 (71,43porcento) dos cones-CAF, todos compatíveis com os resultados citoistológicos prévios. Ocorreu comprometimento das margens em 14/35 (40porcento) dos cones. O material coletado por CEE foi insuficiente em 6/14 (42,86porcento) e positivo em 3/14 (21,43porcento) dos restantes. A CE se apresentou inconclusiva em 5/14 (35,72porcento) dos casos e positiva em 3/14 (21,43porcento). Os limites das lesöes colposcópicas näo foram visibilizados em 12/35 (34,29porcento)pacientes e, deste total, 3/12 (25porcento) das lesöes endocervicais foram detectadas através do material coletado pelas CE/CEE. Cnclusöes: considerando a alta incidência de comprometimento das margens do cone pós-CAF, ambos os métodos CE e CEE se mostraram úteis como instrumentos primários de detecçäo em um terço dos casos estudados. Estes resultados prliminares devem ser melhor avaliados com a sua inclusäo no protocolo de rotina, especialmente indicado em pacientes apresentando lesöes colposcópias de limites endocervicais näo visiveis. O acompanhamento a longo-prazo maiores reduzirá o número de coletas insuficientes/inconclusivas, possibilitando melhores conclusöes sobre ambos os métodos e permitindo, inclusive, prevenir as indicaçöes de histerectomia devido a lesöes residuais pós-cone (au)