Idiopathic localized hyperhidrosis, called for hyperhidrosis, affects almost 3% of the US population. The most frequent anatomic sites of involvement include the axillae, palms, soles, and face. For those affected, this condition can be extremely socially debilitating and interfere with work activities. Until recently, frequently ineffective topical regimens or problematic surgical procedures have been the treatments of choice. Since 1996, intracutaneous injections of botulinum toxin have been used as a minimally invasive treatment for this condition with numerous studies documenting safety, efficacy, and extremely high levels of patient satisfaction. Botulinum toxin type A (Botox) was approved by the US Food and Drug Administration in 2004 for the treatment of axillary hyperhidrosis.
"Primary hyperhidrosis is a disorder of unknown cause (idiopathic) but may be exacerbated by stress.1,2 It affects both men and women equally (2.8% of the general population in the United States),3 and can be extremely socially debilitating, interfering with work activities and negatively affecting the patients’ quality of life.4,5 "
[Show abstract][Hide abstract] ABSTRACT: Background: Hyperhidrosis is a chronic disease characterized by increased sweat production. Local injections of botulinum toxin A (BTX-A) have been extensively used for treatment of primary hyperhidrosis (idiopathic). The current treatment for this condition involves several intradermal injections, resulting in poor patient compliance due to injection-related pain. Therefore, new protocols, including an improved anesthetic regimen, are required.
Aim: We designed the present study to determine whether JetPeel™-3, a medical device used for transdermal delivery of drugs by jet nebulization, could be used to deliver lidocaine prior to the standard multiple BTX-A injections or deliver lidocaine together with BTX-A in order to determine the protocol giving better results in terms of procedure-related pain, sweating, and patient satisfaction in subjects affected by primary axillary, palmar or plantar hyperhidrosis.
Materials and methods: Twenty patients with a visual analog scale (VAS) sweating score > 8 cm were randomized to receive lidocaine 2% (5 mL) delivered by JetPeel™-3 followed by multiple injections of BTX-A (100 units) or lidocaine 2% (5 mL) and BTX-A (50 units) delivered together by JetPeel™-3. Effect of treatment on sweating was measured by VAS (0= minimum sweating; 10= maximum sweating) at 3-month follow-up. Pain induced by the procedure was assessed by VAS (0= minimum pain; 10= maximum pain) immediately after the procedure. Patient satisfaction was assessed at 3-month follow-up using a 5-point scale (1= not at all satisfied; 2= not satisfied; 3= partially satisfied; 4= satisfied; 5= highly satisfied).
Results: Both treatment modalities reduced sweating at 3-month follow-up, if compared with baseline (all P < 0.001). Delivery of lidocaine and BTX-A by JetPeel™-3 resulted in lower procedure-related pain and reduced sweating, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (all P < 0.001). Patient satisfaction with the procedure was higher in the group receiving lidocaine and BTX-A treatment by JetPeel™-3, if compared with lidocaine delivered by JetPeel™-3 followed by multiple BTX-A injections (P < 0.001). No side effects were observed in both groups.
Conclusion: Lidocaine and BTX-A can be safely delivered together by JetPeel™-3 to treat primary palmar, plantar and axillary hyperhidrosis, resulting in lower procedure-related pain, improved sweating and higher patient satisfaction, if compared with lidocaine delivered by JetPeel™-3 followed by standard BTX-A injection therapy. Our protocol delivering lidocaine and BTX-A together by JetPeel™-3 requires a reduced quantity of BTX-A, further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis.
Drug Design, Development and Therapy 07/2014; 8:931–935. DOI:10.2147/DDDT.S60389 · 3.03 Impact Factor
"Systemic medications , including anticholinergic agents and beta blockers, have limited efficacy and substantial side effects. Surgical approaches are irreversible and may be associated with increased compensatory sweating in other body areas (Cohen et al., 2007). "
[Show abstract][Hide abstract] ABSTRACT: Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of certain hypersecretory disorders, including hyperhidrosis, sialorrhea, and chronic rhinorrhea, an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, the serotypes BoNT-A and BoNT-B, as well as the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations for each therapeutic indication, based upon the strength of clinical evidence and following the AAN classification scale. For the treatment of axillary hyperhidrosis in a total of 923 patients, the evidence supported a Level A recommendation for BoNT-A, with a Level B recommendation for A/Abo and A/Ona and a Level U recommendation (insufficient data) for A/Inco and B/Rima. Five trials in 82 patients supported the use of BoNT in palmar hyperhidrosis, with a Level B recommendation for BoNT-A and a Level C recommendation for BoNT-B; individual formulations received a Level U rating due to insufficient data. BoNT (and all individual formulations) received a Level U recommendation for the treatment of gustatory sweating. Support for use of BoNT in sialorrhea was derived from eight trials in a total of 222 adults and children. Evidence supported a Level B recommendation for A/Abo, A/Ona, and B/Rima and a Level U recommendation for A/Inco. Evidence supported a Level B recommendation for A/Ona for the treatment of allergic rhinitis, based on two Class II studies in 73 patients. A lack of published studies for A/Abo, A/Inco, or B/Rima supported a Level U recommendation for those formulations. Further clarity on the optimal mode of administration and additional studies using other BoNT formulations are needed to fill current evidence gaps.
[Show abstract][Hide abstract] ABSTRACT: Although the cause of hyperhidrosis has not been the subject of close investigation, there are cases for which excessive sweating happens at the hands, feet and armpits due to hyperactivity of the sympathetic nervous system. This usually occurs in people less than 25 years old and it often causes difficulties for their social and occupational life and there is a decrease in the quality of life. Therefore, this should also be examined according to the mental state of the patient who suffers from hyperhidrosis.
The Korean Journal of Pain 01/2008; 21(3). DOI:10.3344/kjp.2008.21.3.206
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