RESUMO
Primary axillary hyperhidrosis (PAH), or excessive sweating limited to the axillary area, is a debilitating disease that severely and negatively impacts social and psychological well-being. Several treatment options are available for PAH; however, these options have been shown to provide varying effectiveness. Recent studies have suggested another treatment alternative offering an effective PAH treatment option with reported long-term results. High intensity focused fractional radiofrequency (HIFRF) microneedling is FDA cleared for the treatment of facial wrinkles. The system is designed with a unique technology that is safe for use on patients presenting with all skin types. Based on its unique design and the clinical trial experience reported in the literature by Kim, et al1 and others,2,5 we offer it to our patients as a beneficial treatment option for primary axillary hyperhidrosis (PAH). We present here a clinical experience summary from three US centers providing hyperhidrosis treatments using the high-intensity radio-frequency device, including treatment parameters, clinical outcomes, and pre- and post-treatment images. J Drugs Dermatol. 2018;17(7):745-748.
Assuntos
Antiperspirantes/uso terapêutico , Hiperidrose/terapia , Terapia por Radiofrequência , Adulto , Idoso , Axila , Ensaios Clínicos como Assunto , Feminino , Humanos , Hiperidrose/diagnóstico , Masculino , Pessoa de Meia-Idade , Agulhas/efeitos adversos , Satisfação do Paciente , Ondas de Rádio/efeitos adversos , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment. OBJECTIVE: The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment. PATIENTS AND METHODS: After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected. RESULTS: The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS. CONCLUSION: These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.