The Efficacy and Safety of a Fractional Microneedle Radiofrequency Device for the Treatment of Axillary Hyperhidrosis: Clinical Prospective Pilot Study

Overview

Journal Lasers Med Sci

Publisher Springer

Date 2021 Aug 28

PMID 34453655

Authors

Joon Min Jung

Hyoung Min Na

Jung Ho Kim

Jihae Yoon

Hee Joo Yang

Woo Jin Lee

Sung Eun Chang

Mi Woo Lee

Chong Hyun Won

Affiliations

Soon will be listed here.

Abstract

We aimed to evaluate the efficacy and safety of a fractional microneedle radiofrequency device (FMRD) for the treatment of primary axillary hyperhidrosis (PAH). The FMRD adopted insulated microneedles, which could be located at a depth of up to 4.5 mm and deliver a radiofrequency current in a fractional manner. Also, the device could automatically regulate the amount of the delivered energy. Sixteen Korean patients with PAH received two FMRD treatment sessions at a 3-week interval and were followed-up until week 15. The primary outcome was Patient Satisfaction Scale (PSS) score at each visit. Hyperhidrosis Disease Severity Scale (HDSS) and Global Aesthetic Improvement Scale (GAIS) were also assessed. The area and amount of sweat produced were evaluated by specific tests. Mean PSS score significantly improved from 1.6 at week 3 to 2.5 at week 15 by 56%. More than a 50% improvement in sweating assessed by the PSS score was seen in 63% and 50% of patients at weeks 11 and 15, respectively. Mean HDSS score significantly decreased by week 3 and further decreased by week 7. Mean GAIS scores improved from the first follow-up visit at week 3 and improved again at week 7. The mean hyperhidrosis area assessed by starch-iodine test significantly decreased by 36% at week 15 compared with baseline. Mean transepidermal water loss level significantly decreased by 42% at week 15 compared with baseline. No patients experienced any serious adverse events. FMRD can be an effective and safe treatment modality for PAH.

References

Nawrocki S, Cha J . The etiology, diagnosis, and management of hyperhidrosis: A comprehensive review: Etiology and clinical work-up. J Am Acad Dermatol. 2019; 81(3):657-666. DOI: 10.1016/j.jaad.2018.12.071. View

Sato K, Kang W, Saga K, Sato K . Biology of sweat glands and their disorders. I. Normal sweat gland function. J Am Acad Dermatol. 1989; 20(4):537-63. DOI: 10.1016/s0190-9622(89)70063-3. View

Kreyden O, Scheidegger E . Anatomy of the sweat glands, pharmacology of botulinum toxin, and distinctive syndromes associated with hyperhidrosis. Clin Dermatol. 2004; 22(1):40-4. DOI: 10.1016/j.clindermatol.2003.12.029. View

Cohen J, Cohen G, Solish N, Murray C . Diagnosis, impact, and management of focal hyperhidrosis: treatment review including botulinum toxin therapy. Facial Plast Surg Clin North Am. 2007; 15(1):17-30, v-vi. DOI: 10.1016/j.fsc.2006.10.002. View

Strutton D, Kowalski J, Glaser D, Stang P . US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004; 51(2):241-8. DOI: 10.1016/j.jaad.2003.12.040. View

Eisenach J, Atkinson J, Fealey R . Hyperhidrosis: evolving therapies for a well-established phenomenon. Mayo Clin Proc. 2005; 80(5):657-66. DOI: 10.4065/80.5.657. View

Nawrocki S, Cha J . The etiology, diagnosis, and management of hyperhidrosis: A comprehensive review: Therapeutic options. J Am Acad Dermatol. 2019; 81(3):669-680. DOI: 10.1016/j.jaad.2018.11.066. View

Kim M, Shin J, Lee J, Kim J, Oh S . Efficacy of fractional microneedle radiofrequency device in the treatment of primary axillary hyperhidrosis: a pilot study. Dermatology. 2013; 227(3):243-9. DOI: 10.1159/000354602. View

Fatemi Naeini F, Abtahi-Naeini B, Pourazizi M, Nilforoushzadeh M, Mirmohammadkhani M . Fractionated microneedle radiofrequency for treatment of primary axillary hyperhidrosis: A sham control study. Australas J Dermatol. 2014; 56(4):279-84. DOI: 10.1111/ajd.12260. View

10.

Moraites E, Vaughn O, Hill S . Incidence and prevalence of hyperhidrosis. Dermatol Clin. 2014; 32(4):457-65. DOI: 10.1016/j.det.2014.06.006. View

11.

Walling H . Primary hyperhidrosis increases the risk of cutaneous infection: a case-control study of 387 patients. J Am Acad Dermatol. 2009; 61(2):242-6. DOI: 10.1016/j.jaad.2009.02.038. View

12.

Gee S, Yamauchi P . Nonsurgical management of hyperhidrosis. Thorac Surg Clin. 2008; 18(2):141-55. DOI: 10.1016/j.thorsurg.2008.01.003. View

13.

Holzle E . Topical pharmacological treatment. Curr Probl Dermatol. 2002; 30:30-43. DOI: 10.1159/000060693. View

14.

Benohanian A, Dansereau A, Bolduc C, Bloom E . Localized hyperhidrosis treated with aluminum chloride in a salicylic acid gel base. Int J Dermatol. 1998; 37(9):701-3. DOI: 10.1046/j.1365-4362.1998.00543.x. View

15.

Goh C . Aluminum chloride hexahydrate versus palmar hyperhidrosis. Evaporimeter assessment. Int J Dermatol. 1990; 29(5):368-70. DOI: 10.1111/j.1365-4362.1990.tb04766.x. View

16.

Heckmann M, Ceballos-Baumann A, Plewig G . Botulinum toxin A for axillary hyperhidrosis (excessive sweating). N Engl J Med. 2001; 344(7):488-93. DOI: 10.1056/NEJM200102153440704. View

17.

Naumann M, Lowe N . Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BMJ. 2001; 323(7313):596-9. PMC: 55572. DOI: 10.1136/bmj.323.7313.596. View

18.

Rouientan A, Alizadeh Otaghvar H, Mahmoudvand H, TizMaghz A . Rare Complication of Botox Injection: A Case Report. World J Plast Surg. 2019; 8(1):116-119. PMC: 6409137. DOI: 10.29252/wjps.8.1.116. View

19.

Bajaj V, Langtry J . Use of oral glycopyrronium bromide in hyperhidrosis. Br J Dermatol. 2007; 157(1):118-21. DOI: 10.1111/j.1365-2133.2007.07884.x. View

20.

Connolly M, de Berker D . Management of primary hyperhidrosis: a summary of the different treatment modalities. Am J Clin Dermatol. 2003; 4(10):681-97. DOI: 10.2165/00128071-200304100-00003. View