Efficacy of Fractional Microneedle Radiofrequency Device in the Treatment of Primary Axillary Hyperhidrosis: A Pilot Study

Abstract

Background: Fractional microneedle radiofrequency (FMR) devices deliver energy to the deep dermis through insulated microneedles without destroying the epidermis. These FMR devices have been shown to be effective for the treatment of wrinkles, acne scars and large pores. In this study it was postulated that FMR energy could specifically affect the sweat glands, preserving the skin surface even if sweat glands were seated in the deep dermis. Objective: To evaluate the efficacy and safety of FMR for primary axillary hyperhidrosis (PAH) treatment and to conduct a histological analysis before and after treatment. Methods: Twenty patients with PAH had 2 sessions of bipolar FMR treatment at 4-week intervals. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 2 months after the last treatment. The amount of sweat reduction was indirectly assessed using a Tewameter™. Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit. Results: HDSS scores decreased significantly from a baseline of 3.3 to 1.5 and 1.8 after the first and second months of posttreatment follow-up sessions, respectively (p < 0.001). In response to a subjective assessment at 1 month after the second treatment, 75% of patients (n = 15) had an HDSS score of 1 or 2, and 70% of patients (n = 14) expressed more than 50% improvement in their sweating. The starch-iodine reaction was also remarkably reduced in 95% of patients (n = 19) after FMR treatment. Histological findings showed a decrease in the number and size of both apocrine and eccrine glands 1 month after the final treatment. Side effects were minimal and included mild discomfort, transient swelling and postinflammatory hyperpigmentation. Conclusion: FMR treatment was effective for the treatment of PAH without significant adverse reactions due to direct volumetric heating of the lower dermis.

Histopathological evidence of efficacy of microneedle radiofrequency for treatment of axillary hyperhidrosis

“…They demonstrated gross pathological and histological response with generation of thermally affected zones in the desired target region while providing protection to the upper skin layers. [5,10,12] Even though fractionated microneedle radiofrequency can be used as an effective, harmless, and nonaggressive method for treatment of primary axillary hyperhidrosis, further studies are needed to confirm and clearly define the histopathological changes induced in the skin by radiofrequency. [11] Our patients showed similar histologic findings of destruction of eccrine and apocrine glands and associated cell necrosis that localized at the junction of deep dermis and subcutaneous tissue.…”

“…[5] The disease evolves according to the patient's immunity. Unusual clinical manifestations have been reported.…”

Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis

“…Studies that were found to use the HDSS tool were conducted globally, including the USA and Canada (n = 21 21,27,29,52,77,107,108,139,159,160,164,175,176,179,180,208,209,218,225,226,229 ), Spain (n = 6 167,207,210,224,230,231 ), the UK (n = 5 91,97,125,222,232 ), Germany (n = 5 2,131,145,161,227 ), Italy (n = 5 102,106, 136,214,223 ), France (n = 3 59,61,211 ), South Korea (n = 3 51,171,174 ), Australia (n = 2 53,221 ), Egypt (n = 2 213,219 ), Iran (n = 2 28,220 ), the Netherlands (n = 2 ...…”

Microneedle fractional radiofrequency‐induced micropores evaluated by in vivo reflectance confocal microscopy, optical coherence tomography, and histology

“…When radiofrequency (RF) encounters the skin's inherent resistance, electrical current is converted to thermal energy . MNRF's thermal effects have previously been examined histologically . However, MNRF‐induced micropores and accompanying tissue alteration have yet to be examined by noninvasive in vivo imaging techniques.…”