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.

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.

• Authors: Tommaso Iannitti, Beniamino Palmieri, Anna Aspiro, Alessandro Di Cerbo
• Journal: Drug design, development and therapy (Drug Des Devel Ther) Vol. 8 Pg. 931-5 ( 2014) ISSN: 1177-8881 [Electronic] New Zealand
• PMID: 25075176 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anesthetics, Local
• Neuromuscular Agents
• Lidocaine
• Botulinum Toxins, Type A

Topics

• Administration, Cutaneous
• Adult
• Anesthetics, Local (administration & dosage)
• Botulinum Toxins, Type A (administration & dosage)
• Drug Delivery Systems
• Equipment Design
• Female
• Follow-Up Studies
• Humans
• Hyperhidrosis (drug therapy)
• Lidocaine (administration & dosage)
• Male
• Nebulizers and Vaporizers
• Neuromuscular Agents (administration & dosage)
• Pain (epidemiology, etiology)
• Pain Measurement
• Patient Satisfaction
• Treatment Outcome