Dong Geon Lee1, Jung Eun Kim1, Woo Shun Lee2, Moon-Bum Kim3, Chang-Hun Huh4, Yang Won Lee5, Gwang Seong Choi6, Jee-Bum Lee7, Dong Soo Yu8, Min Kyung Shin9, Mi Ryung Roh10, Hyo Hyun Ahn11, Won-Serk Kim12, Jong Hee Lee13, Kui Young Park14, Jin Park15, Weon Ju Lee16, Mi Youn Park17, Hoon Kang18. 1. Department of Dermatology, Eunpyeong St. Mary's hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Korea. 2. Medytox Inc., Seoul, Korea. 3. Department of Dermatology, Pusan National University School of Medicine, Busan, Korea. 4. Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Korea. 5. Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea. 6. Department of Dermatology, Inha University School of Medicine, Incheon, Korea. 7. Department of Dermatology, Chonnam National University Medical School, Gwangju, Korea. 8. Department of Dermatology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. 9. Department of Dermatology, School of Medicine, Kyung Hee University, Seoul, Korea. 10. Department of Dermatology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. 11. Department of Dermatology, College of Medicine, Korea University, Seoul, Korea. 12. Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. 13. Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 14. Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea. 15. Department of Dermatology, Jeonbuk National University Medical school, Jeonju, Korea. 16. Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea. 17. Department of Dermatology, National Medical Center, Seoul, Korea. 18. Department of Dermatology, Eunpyeong St. Mary's hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Korea. johnkang@catholic.ac.kr.
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. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .