title: A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis.
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.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: School of Biomedical Sciences, University of Leeds, Leeds, UK ; Poliambulatorio del Secondo Parere, Modena, Italy.
authors: Tommaso
authors: T
authors: Iannitti
authors: Department of Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy.
authors: Beniamino
authors: B
authors: Palmieri
authors: Department of Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy.
authors: Anna
authors: A
authors: Aspiro
authors: Poliambulatorio del Secondo Parere, Modena, Italy ; Department of Surgery and Surgical Specialties, University of Modena and Reggio Emilia Medical School, Surgical Clinic, Modena, Italy.
authors: Alessandro
authors: A
authors: Di Cerbo
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000779:Anesthetics, Local / Q000008:administration & dosage; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D016503:Drug Delivery Systems; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006945:Hyperhidrosis / Q000188:drug therapy*; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D009330:Nebulizers and Vaporizers; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D016896:Treatment Outcome
chemical_list: D000779:Anesthetics, Local; D009465:Neuromuscular Agents; D008012:Lidocaine; D019274:Botulinum Toxins, Type A
keywords: JetPeel™-3; anesthesia; botulinum toxin A; hyperhidrosis; jet nebulization; pain; sweating; transdermal drug delivery