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A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis
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,...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106921/ https://www.ncbi.nlm.nih.gov/pubmed/25075176 http://dx.doi.org/10.2147/DDDT.S60389 |
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author | Iannitti, Tommaso Palmieri, Beniamino Aspiro, Anna Di Cerbo, Alessandro |
author_facet | Iannitti, Tommaso Palmieri, Beniamino Aspiro, Anna Di Cerbo, Alessandro |
author_sort | Iannitti, Tommaso |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4106921 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-41069212014-07-29 A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis Iannitti, Tommaso Palmieri, Beniamino Aspiro, Anna Di Cerbo, Alessandro Drug Des Devel Ther Original Research 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. Dove Medical Press 2014-07-14 /pmc/articles/PMC4106921/ /pubmed/25075176 http://dx.doi.org/10.2147/DDDT.S60389 Text en © 2014 Iannitti et al. This work is published by Dove Medical Press Ltd, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Ltd, provided the work is properly attributed. |
spellingShingle | Original Research Iannitti, Tommaso Palmieri, Beniamino Aspiro, Anna Di Cerbo, Alessandro A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title | A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title_full | A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title_fullStr | A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title_full_unstemmed | A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title_short | A preliminary study of painless and effective transdermal botulinum toxin A delivery by jet nebulization for treatment of primary hyperhidrosis |
title_sort | preliminary study of painless and effective transdermal botulinum toxin a delivery by jet nebulization for treatment of primary hyperhidrosis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106921/ https://www.ncbi.nlm.nih.gov/pubmed/25075176 http://dx.doi.org/10.2147/DDDT.S60389 |
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