The Efficacy and Safety of Botulinum Toxin Type A in Patients with Primary Axillary Hyperhidrosis

DOI Web Site 17 References

Bibliographic Information

Other Title
  • 原発性腋窩多汗症患者に対する A 型ボツリヌス毒素製剤の治療評価
  • 治療 原発性腋窩多汗症患者に対するA型ボツリヌス毒素製剤の治療評価
  • チリョウ ゲンパツセイエキカタカンショウ カンジャ ニ タイスル Aガタ ボツリヌス ドクソ セイザイ ノ チリョウ ヒョウカ

Search this article

Description

Botulinum Toxin Type A (BoNTA) has already been widely used for the treatment of primary axillary hyperhidrosis and its efficacy and safety has been established in overseas trials. The superiority of a single treatment of BoNTA over placebo based on gravimetric assessment of sweat production in adult Japanese patients with primary axillary hyperhidrosis was demonstrated. Moreover the efficacy and safety of up to 2 treatments with BoNTA was assessed. One hundred and fifty two patients with primary axillary hyperhidrosis were randomized to receive a single treatment with either BoNTA 50 U in each axilla (100 U in total) or placebo in the double blind phase. Patients who met the re-injection criteria at Week 16, 20 or 24 after the first treatment received BoNTA 50 U in each axilla and were observed until Week 40 following the first treatment. A statistically significantly higher responder rate based on gravimetric measurement of sweat production at Week 4 after the first treatment was seen in the BoNTA group (96.2%) compared to the placebo group (45.9%) (p < 0.001). This result indicated the superiority of BoNTA over placebo. Moreover, the effect of BoNTA treatment did not diminish with repeated treatment. The incidence of treatment-related adverse events was not different between BoNTA group (3%) and placebo group (3%). There were no increases in the frequency of adverse events over the repeated treatment. In conclusion, the efficacy of single treatment of BoNTA for primary axillary hyperhidrosis in Japanese was demonstrated by the statistically significant reduction in sweat production in the BoNTA group versus vehicle. Furthermore, the efficacy and safety of repeated treatment of BoNTA was also demonstrated.

Journal

References(17)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top