Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application. Final order.

The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Eficácia da fototerapia associada à sulfadiazina de prata no tratamento de úlceras venosas crônicas / Efficacy of the phototherapy associated with silver sulphadiazine in the treatment of chronic venous ulcers

Introdução: Várias são as propostas terapêuticas para úlceras de perna venosas crônicas (UVCs), como curativos, ultrassom, aparelhos fotobioestimuladores (laser/LED) e outros. Objetivo: Analisar a eficácia da fototerapia (LED 660/890 nm) com curativo diário de sulfadiazina de prata 1 por cento creme (SDZ) para úlceras venosas crônicas. Métodos: Estudo randomizado, duplo-cego, com aparelho fototerápico com 2 sondas: 1 (LED 660 nm/5mW) e 2 (1 LED 660 nm e 32 LED 890 nm/500 mW). Selecionaram-se 20 pacientes (n = 32 úlceras) do Ambulatório de Úlceras CSE–FMRP–USP, constituindo-se grupos: G1-sonda 1+SDZ; G2-sonda 2+SDZ e G3-SDZ, seguidos por 90 dias. Aplicaram-se sobre as úlceras, as sondas pontualmente (3,0 J/cm2, 30 seg/5cm2, 2x/semana) e posterior curativo SDZ. Quinzenalmente, foram fotografadas e avaliadas pelo software Image Jâ, mensurando-se as áreas [total, de esfacelo (E); e de tecido de granulação (G)], calculando-se índices de cicatrização das úlceras [ICU = (Ai-Af)/Ai)] e relação E/G. Resultados: G2 apresentou redução significante no 30º e 90º dia (p 0,4, G2 alcançou este índice em 75 por cento das úlceras no 30º e 90º dias, enquanto 33 por cento do G1, somente no 60º. Conclusão: A fototerapia (LED’s) associada à SDZ acelerou processo de cicatrização das UVCs (G1/G2), comparada ao creme isoladamente (G3), pelos ICUs e pela relação E/G.

Introduction: Many therapeutic forms were used to treat chronic venous ulcers such as dressing, ultrasound, photobiostimulator (laser/LED) and other. Objective: To analyze effectiveness of photo­therapy (LED 660/890 nm) with 1 percent silver sulfadiazine cream (SDZ) in chronic venous ulcers. Method: Randomized and double-blind study using the phototherapy device with 2 probes: 1 (LED 660 nm/5mW) and 2 (1 LED 660 nm and 32 LED 890 nm, 500 mW). Twenty patients were selected (n = 32 ulcers) from Ulcer Outpatient Clinic of the School Health Center –FMRP–USP, divided into groups: G1-probe1+SDZ, G2-probe2+SDZ and G3-SDZ, during 90 days. The probes were applied on ulcers, punctually (3 J/cm2, 30 sec/5cm2, twice/week) and posterior daily SDZ’s dressing. Fortnightly, the ulcers were photographed and evaluated by Image J® software, measuring the areas [total, sphacellus (S) and granulation tissue(G)], calculating wound healing rate [WHR = (iA-fA)/iA)] and S/G relation. Results: G2 presented significant reduction in the 30th and 90th days (p 0.4, G2 achieved this rate in 75 percent of the ulcers in the 30th and 90th days, while 33 percent of the G1 only in the 60th days. Conclusion: The phototherapy (LED) associated with SDZ accelerated wound healing of the venous ulcers (G1/G2) compared the cream (G3) by WHRs and S/G relation.

Urticaria solar. Estudio de 20 casos / Solar urticaria. Study of 20 cases

Introducción. La urticaria solar es una enfermedad poco frecuente, pero probablemente infradiagnosticada. Se caracteriza por la aparición de forma súbita de habones en zonas habitualmente no fotoexpuestas tras irradiación solar o con otras fuentes artificiales de luz visible o ultravioleta. Los casos publicados en la literatura médica son pocos, por lo que la información que tenemos acerca de la enfermedad y su evolución natural es limitada. Material y métodos. Se han recopilado los datos de los 20 pacientes que han sido diagnosticados de urticaria solar en nuestro servicio en los últimos 12 años (1990-2002), para intentar obtener información acerca de las características de esta enfermedad. Resultados. Como características más relevantes de nuestra serie cabe destacar que el 60 % de los pacientes eran mujeres; la duración media de la enfermedad antes de acudir a un dermatólogo era de alrededor de 3 años. En el 55 % de los pacientes se respetaban zonas habitualmente fotoexpuestas como cara y manos (fenómeno de habituación o hardening). Los espectros responsables de la urticaria solar eran luz visible, UVA y UVB, por ese orden. Respecto a los tratamientos, con antihistamínicos y fotoprotectores se obtuvo una respuesta parcial y buenos resultados mediante desensibilizaciones progresivas con UVA/sol. Conclusión. La urticaria solar es probablemente una enfermedad infradiagnosticada en nuestro medio. Hay pocas series publicadas que nos permitan conocer las características más importantes de la enfermedad. Se han recopilado los datos más interesantes de nuestros pacientes y se han comparado con el resto de las series publicadas en el intento de conocer mejor esta fotodermatosis

Introduction. Solar urticaria is an infrequent disorder, but is probably underdiagnosed. It is characterized by the sudden appearance of weals in areas that are not usually photoexposed after exposure to the sun or to artificial sources of visible or ultraviolet light. Few cases have been published in literature, so the information available about this disorder and its natural evolution is limited. Material and methods. We have compiled data from 20 patients diagnosed with solar urticaria in our department in the last 12 years (1990-2002) in order to try to obtain information about the characteristics of this condition. Results. As the most relevant characteristics of our series, we can mention the fact that 60 % of the patients were women, and the average duration of the condition before consulting a dermatologist was 3 years. In 55 % of the patients, areas that are usually photoexposed, such as the face and hands, were less severely affected (due to acclimatization or hardening). The spectra responsible for the SU were visible light, UVA and UVB, in that order. With regard to treatment, we obtained a partial response with antihistamines and photoprotectors, and good results using progressive desensitization with UVA/sunlight. Conclusion. Solar urticaria is probably an underdiagnosed condition in our milieu. There are few series in literature that provide any information about the most significant characteristics of this disorder. We have compiled the most relevant data from our patients and we have compared it with the other published series in an attempt to learn more about this photodermatosis