A Phase 3, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Neu-BoNT/A in Treatment of Primary Axillary Hyperhidrosis
- Authors
- Lee, Dong Geon; Kim, Jung Eun; Lee, Woo Shun; Kim, Moon-Bum; Huh, Chang-Hun; Lee, Yang Won; Choi, Gwang Seong; Lee, Jee-Bum; Yu, Dong Soo; Shin, Min Kyung; Roh, Mi Ryung; Ahn, Hyo Hyun; Kim, Won-Serk; Lee, Jong Hee; Park, Kui Young; Park, Jin; Lee, Weon Ju; Park, Mi Youn; Kang, Hoon
- Issue Date
- Jun-2022
- Publisher
- SPRINGER
- Keywords
- Neu-BoNT/A; Botulinum toxin; Primary axillary hyperhidrosis
- Citation
- AESTHETIC PLASTIC SURGERY, v.46, no.3, pp 1400 - 1406
- Pages
- 7
- Journal Title
- AESTHETIC PLASTIC SURGERY
- Volume
- 46
- Number
- 3
- Start Page
- 1400
- End Page
- 1406
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/61699
- DOI
- 10.1007/s00266-021-02715-4
- ISSN
- 0364-216X
1432-5241
- Abstract
- Background Botulinum toxin type A is widely used to treat primary axillary hyperhidrosis and has proven to be an effective and safe approach. Onabotulinumtoxin A was approved by the FDA as a treatment for primary axillary hyperhidrosis. This study aimed to evaluate the efficacy and safety of Neu-BoNT/A in subjects diagnosed with primary axillary hyperhidrosis. Methods The Hyperhidrosis Disease Severity Scale, gravimetric measurement of sweat, and Global Assessment Scale were analyzed at weeks 4, 8, 12, and 16 to determine the effect of treatment. Adverse events, physical examination, and vital signs were monitored. Results Subjects treated with Neu-BoNT/A showed statistically significant improvement by all 3 methods at weeks 4, 8, 12, and 16 (P value = 0.00). There were no severe adverse events or significant changes in vital signs, physical examination, or laboratory tests. Conclusion Neu-BoNT/A can be effectively and safely used for primary axillary hyperhidrosis.
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