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A Phase 3, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Neu-BoNT/A in Treatment of Primary Axillary Hyperhidrosis

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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.

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Funding

Products used in the study (Neu-BoNT/A (Meditoxin®, Medytox Inc., Cheongwon-gu, Korea) were sponsored by Medytox, Inc.

Author information

Authors and Affiliations

  1. Department of Dermatology, Eunpyeong St. Mary’s hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Korea

    Dong Geon Lee, Jung Eun Kim & Hoon Kang

  2. Medytox Inc., Seoul, Korea

    Woo Shun Lee

  3. Department of Dermatology, Pusan National University School of Medicine, Busan, Korea

    Moon-Bum Kim

  4. Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Korea

    Chang-hun Huh

  5. Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea

    Yang Won Lee

  6. Department of Dermatology, Inha University School of Medicine, Incheon, Korea

    Gwang Seong Choi

  7. Department of Dermatology, Chonnam National University Medical School, Gwangju, Korea

    Jee-Bum Lee

  8. Department of Dermatology, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

    Dong Soo Yu

  9. Department of Dermatology, School of Medicine, Kyung Hee University, Seoul, Korea

    Min Kyung Shin

  10. Department of Dermatology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

    Mi Ryung Roh

  11. Department of Dermatology, College of Medicine, Korea University, Seoul, Korea

    Hyo Hyun Ahn

  12. Department of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

    Won-serk Kim

  13. Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

    Jong Hee Lee

  14. Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea

    Kui Young Park

  15. Department of Dermatology, Jeonbuk National University Medical school, Jeonju, Korea

    Jin Park

  16. Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea

    Weon Ju Lee

  17. Department of Dermatology, National Medical Center, Seoul, Korea

    Mi Youn Park

Authors
  1. Dong Geon Lee
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  2. Jung Eun Kim
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  3. Woo Shun Lee
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  4. Moon-Bum Kim
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  5. Chang-hun Huh
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  6. Yang Won Lee
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  7. Gwang Seong Choi
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  8. Jee-Bum Lee
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  9. Dong Soo Yu
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  10. Min Kyung Shin
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  11. Mi Ryung Roh
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  12. Hyo Hyun Ahn
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  13. Won-serk Kim
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  14. Jong Hee Lee
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  15. Kui Young Park
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  16. Jin Park
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  17. Weon Ju Lee
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  18. Mi Youn Park
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  19. Hoon Kang
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Corresponding author

Correspondence to Hoon Kang.

Ethics declarations

Conflict of interest

Dr. Woo Shun Lee is an employee of Medytox Inc., Korea. None of the others has a financial interest in any of the products, devices, or drugs mentioned in this manuscript.

Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Ethical Approval

This study was approved by the institutional review board of each institution and complied with all international and local rules for good clinical practice.

Consent for Participation

All participants provided written informed consent to participate in the study.

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Lee, D.G., Kim, J.E., Lee, W.S. et al. A Phase 3, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Neu-BoNT/A in Treatment of Primary Axillary Hyperhidrosis. Aesth Plast Surg 46, 1400–1406 (2022). https://doi.org/10.1007/s00266-021-02715-4

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  • DOI: https://doi.org/10.1007/s00266-021-02715-4

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