Efficacy and safety of PenlesⓇ Tape 18 mg （lidocaine tape） for pain relief during molluscum contagiosum removal - Special drug use investigation in children

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  • Hino Haruko
    Department of Dermatology, Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
  • Baba Naoko
    Department of Dermatology, Kanagawa Children’s Medical Center
  • Unozawa Senji
    Pharmacovigilance & Quality Assurance Dept., Medical Div., Nitto Denko Corporation
  • Tokuda Shouichi
    Pharmacovigilance & Quality Assurance Dept., Medical Div., Nitto Denko Corporation
  • Kawaharada Yuji
    Pharmacovigilance & Quality Assurance Dept., Medical Div., Nitto Denko Corporation
  • Nakamura Keigo
    Phamacovigilance & PMS Dept., Maruho Co., Ltd.
  • Kani Tsuyoshi
    Phamacovigilance & PMS Dept., Maruho Co., Ltd.

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Other Title
  • 伝染性軟属腫摘除時の疼痛緩和に対する ペンレスⓇテープ18 mg（リドカインテープ剤）の有効性と 安全性に対する検討（小児特定使用成績調査）
  • 伝染性軟属腫摘除時の疼痛緩和に対するペンレステープ18mg(リドカインテープ剤)の有効性と安全性に対する検討(小児特定使用成績調査)
  • デンセンセイナンゾク シュテキジョジ ノ トウツウ カンワ ニ タイスル ペンレステープ 18mg(リドカインテープザイ)ノ ユウコウセイ ト アンゼンセイ ニ タイスル ケントウ(ショウニ トクテイ シヨウ セイセキ チョウサ)

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OBJECTIVE : A post-marketing surveillance study was performed to investigate the efficacy and safety of PenlesⓇ Tape 18 mg containing 18 mg of lidocaine for pain relief during molluscum contagiosum removal in children. RESULT : A total of 593 patients were enrolled between January 2013 and January 2014, of which 500 patients were included in a safety analysis. Molluscum contagiosum has a high incidence in 3-5 years old. Of the patients enrolled in this study, 40.2% were aged “ 4 years. About 53.9% of the patients exhibited “No physical response on removal,” 37.1% of the patients showed “Slight physical response on removal” and this was considered the pain threshold level, and 8.5% of the patients showed “Considerable physical response on removal.” Adverse drug reactions （ADR） included 4 cases of erythema and 2 cases of contact dermatitis in 6 patients （incidence : 1.20%）. All ADRs were localized, reversible, and not serious. ADRs related to the anesthetic action of lidocaine were not observed. About 68.2% and 25.8% of the doctors rated PenlesⓇ Tape 18 mg as “Very Useful” and “Useful,” respectively. Therefore, we believe that this drug has very high utility. CONCLUSION : The results of the present study confirmed the efficacy and safety of PenlesⓇ Tape 18 mg for pain relief during molluscum contagiosum removal in children including those younger than 4 years.

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