title: Safety evaluation of stamp type digital microneedle devices in hairless mice.
abstract: BACKGROUND
  Microneedles provide a minimally invasive means to transport molecules into the skin. A number of specific strategies have been employed to use microneedles for transdermal delivery.
  
  
  OBJECTIVE
  The purpose of this study was to investigate the safety of two new digital microneedle devices (Digital Hand® and Digital Pro®; Bomtech Electronics Co., Ltd., Seoul, Korea) for the perforation of skin in skin-hairless-1 mice. This device replaces conventional needles and is designed specifically for intradermal delivery.
  
  
  METHODS
  We used two newly developed digital microneedle devices to perforate the skin of skin-hairless-1 mice. We conducted a comparative study of the two digital microneedle devices and DTS® (Disk type-microneedle Therapy System; DTS lab., Seoul, Korea). To evaluate skin stability, we performed visual and dermatoscopic inspections, measurements of transepidermal water loss, and biopsies.
  
  
  RESULTS
  The two novel digital microneedle devices did not induce significant abnormalities of the skin on visual or dermatoscopic inspection, regardless of needle size (0.25~2.0 mm). No significant histopathological changes, such as inflammatory cell infiltration, desquamation of the stratum corneum, or disruption of the basal layer, were observed. The digital microneedle devices and microneedle therapy system produced similar results on measures of skin stability.
  
  
  CONCLUSIONS
  These two novel digital microneedle devices are safe transdermal drug delivery systems.
authors: Department of Dermatology, College of Medicine, Chung-Ang University, Seoul, Korea.
authors: Kui Young
authors: KY
authors: Park
authors: Woo Sun
authors: WS
authors: Jang
authors: Yun Young
authors: YY
authors: Lim
authors: Joo Hee
authors: JH
authors: Ahn
authors: Sang Jin
authors: SJ
authors: Lee
authors: Chan Woong
authors: CW
authors: Kim
authors: Sung Eun
authors: SE
authors: Kim
authors: Beom Joon
authors: BJ
authors: Kim
authors: Myeung Nam
authors: MN
authors: Kim
keywords: Digital; Mesotherapy; Safety; Water loss