Randomized Controlled Trial Comparing the Efficacy and Safety of Two Injection Techniques of IncobotulinumtoxinA for Axillary Hyperhidrosis

July 2020 | Volume 19 | Issue 7 | Original Article | 765 | Copyright © July 2020


Published online June 26, 2020

Ada Regina Trindade de Almeida PhD, Leandro Fonseca Noriega MD, Lilliana Bechelli MD, Maria Victoria Suárez PhD

Clínica de Dermatologia do Hospital do Servidor Público Municipal de São Paulo, São Paulo, Brazil

Abstract
Background: Botulinum toxin A (BoNT-A) is an effective treatment for axillary hyperhidrosis (AH) typically applied by multiple injection punctures.
Objective: To compare the efficacy and safety of two BoNT-A injection techniques for AH.
Methods: Randomized, evaluator-blinded trial, in which each axilla of the same patient received 50 U of incobotulinumtoxin A (IncoA; Xeomin), one injected intradermally using multiple punctures, the other subcutaneously by radial approach. Follow-up visits occurred after 30, 120, 180, and 270 days. Outcomes included procedure duration and pain, gravimetry and starch-iodine tests and safety.
Results: Twenty-four patients with severe hyperhidrosis were included; 67% were female and mean age was 34.7 years. Radial injection was faster applied than multiple punctures (P<0.001) but showed higher pain scores (P=0.001). Pre- and post-treatment gravimetric measures showed that IncoA led to a significant sweat reduction, by both techniques, with 95% of responders (≥50% reduction from baseline) after 30 days of treatment. Similarly, Minor’s test showed an excellent response (90-100% reduction) by most patients regardless of the technique used, after 30 days and sustained for at least 270 days. At most time points, there were no significant differences between the two techniques; however, multiple punctures showed a higher reduction of gravimetric measures at days 30 and 180, and of Minor’s test at day 270. Treatment was well tolerated.
Conclusions: IncoA is an effective and safe treatment for AH irrespective to the technique used for injection. Our study suggests that multiple punctures injection may confer better outcomes at some time points.

J Drugs Dermatol. 2020;19(7): doi:10.36849/JDD.2020.4989

INTRODUCTION

Primary hyperhidrosis (PH) is an idiopathic, chronic disorder characterized by uncontrolled sweat production exceeding that required for homeostasis maintenance.1 Typically in a bilateral and symmetrical pattern, PH can affect different areas of the body, most commonly axillae, palms, soles, and face, with affected patients often sweating from one or two areas of the body.2 The prevalence of PH is widely variable in the literature. In the U.S., a survey with 150,000 households estimated a national prevalence of 2.8%,3 while a more recent study reported the prevalence of hyperhidrosis at 4.8%.4 Of the affected population, more than half of the patients have axillary hyperhidrosis (AH).3,4

AH affects both genders, and symptoms usually manifest during puberty or adolescence.5 It is an emotionally, physically and socially distressing condition that interferes with everyday activities and exerts a negative impact on patients’ quality of life.6,7 Given the burden of excessive sweating, reduction of sweat production is an important goal of management and treatment of AH.8 Botulinum toxin A (BoNT-A) has proven to be an effective and safe treatment for primary AH, promoting high levels of satisfaction among patients.9-11 This treatment can temporarily inhibit excessive sweating by blocking the release of the neurotransmitter acetylcholine, producing efficient chemical gland denervation. It is a minimally invasive procedure that can be administered in outpatient facilities under topical, local, or locoregional anesthesia. Incobotulinumtoxin A (IncoA, Xeomin®, Merz Pharma) was shown to have similar efficacy and safety profiles as onabotulinumtoxin A (Botox®, Allergan).12

For AH, BoNT-A is typically applied by multiple (usually 10 to 20) intradermal injections of small doses per point, spaced 1–2cm apart, to cover the affected area.8,11 Overall, it is an easy, simple and well tolerated procedure. An alternative injection technique involving the use of a more diluted solution (Dr. Rosa Flores, Mexico, personal communication based on Odderson13) injected subcutaneously in a radial manner through two points of entrance has been proposed with the aim of reducing procedure duration. However, its efficacy and safety have not