Clinical study of a retinoic acid-loaded microneedle patch for seborrheic keratosis or senile lentigo

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• 作者：Sachiko Hirobe^a ; Risa Otsuka^a ; Hiroshi Iioka^b ; Ying-Shu Quan^c ; Fumio Kamiyama^c ; Hideo Asada^b ; Naoki Okada^a ; ^{okada@phs.osaka-u.ac.jp} ; Shinsaku Nakagawa^a ; ^{nakagawa@phs.osaka-u.ac.jp}
• 关键词：Microneedle ; Clinical study ; All-trans retinoic acid ; Seborrheic keratosis ; Senile lentigo
• 刊名：Life Sciences
• 出版年：2017
• 出版时间：1 January 2017
• 年：2017
• 卷：168
• 期：Complete
• 页码：24-27
• 全文大小：674 K
• 卷排序：168

文摘

Pigmented lesions such as of seborrheic keratosis and senile lentigo, which are commonly seen on skin of people > 50 years of age, are considered unattractive and disfiguring because of their negative psychological impact. Drug therapy using all-trans retinoic acid (ATRA) is an attractive option for self-treatment at home. We have developed an ATRA-loaded microneedle patch (ATRA-MN) and confirmed the pharmacological effects of ATRA-MN application in mice. Here, we describe a clinical study to evaluate the safety and efficacy of ATRA-MN in subjects with seborrheic keratosis or senile lentigo.Main methodsATRA-MN was applied to the lesion site of each subject for 6 h once per week for 4 weeks. The skin irritation reaction was scored to assess adverse reactions and blood tests were performed to evaluate the presence of systemic adverse reactions. To assess the treatment effect using ATRA-MN, the desquamation and whitening ability of the investigational skin was observed.Key findingsDesquamation of the stratum corneum was observed following four ATRA-MN applications at 1-week intervals, but ATRA-MN applications did not induce severe local or systemic adverse effects.SignificanceThese results showed that ATRA-MN treatment is promising as a safe and effective therapy for seborrheic keratosis and senile lentigo.