Investigation of the effectiveness and safety of ozenoxacin lotion (Zebiax<sup>®</sup> Lotion 2%) on superficial skin infections by a drug use-results survey

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  • 表在性皮膚感染症に対するオゼノキサシンローション（ゼビアックス<sup>®</sup>ローション2%）の使用成績調査による有効性および安全性の検討
  • 表在性皮膚感染症に対するオゼノキサシンローション(ゼビアックスローション2%)の使用成績調査による有効性および安全性の検討
  • ヒョウザイセイ ヒフ カンセンショウ ニ タイスル オゼノキサシンローション(ゼビアックスローション 2%)ノ シヨウ セイセキ チョウサ ニ ヨル ユウコウセイ オヨビ アンゼンセイ ノ ケントウ

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Abstract

Ozenoxacin lotion (Zebiax® Lotion 2%) is a topical quinolone antimicrobial agent approved for the treatment of acne accompanied by suppurative inflammation and superficial skin infections in September 2015. The safety and efficacy were evaluated in the drug use-results survey (observation period: until 7 days after the start date of use) starting in April 2016 for superficial skin infections in clinical practice. Although 4 adverse drug reactions were observed in 4 out of 310 cases (1.29%) in the safety analysis set, all of these reactions were non-serious and developed in patients with impetigo contagiosa aged younger than 13 years who were not included in domestic clinical studies. The adverse reactions included 1 event each of contact dermatitis, application site irritation, application site pain and application site eczema. With regard to the clinical effect, the rate of "markedly effective" and "effective" (efficacy rate) is 67.9% (209/308) of all the cases and the efficacy rate by disease was 53.1% (85/160) for folliculitis, 76.5% (13/17) for purulent periporitis and 84.7% (111/131) for impetigo contagiosa. The efficacy rate in patients aged younger than 13 years was 80.4% (115/143). These results indicate that this drug is useful in superficial skin infections in real clinical settings and also the effectiveness was confirmed on purulent periporitis and impetigo contagiosa that have not been investigated in the domestic clinical studies. It was indicated that by using this drug with caution against irritation in the applied sites, it may become a useful treatment option also in patients aged younger than 13 years.

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