title: Evaluation of the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch via a double-blind, placebo-controlled clinical study.
abstract: OBJECTIVE
  Although an ascorbic acid-loaded dissolving microneedle patch has been developed to improve anti-wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch was evaluated in a double-blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid-loaded dissolving microneedle patch was performed.
  
  
  METHODS
  Twenty-three subjects were selected for anti-wrinkle effect evaluation in a double-blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid-loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid-loaded dissolving microneedle patch and control sample were evaluated.
  
  
  RESULTS
  Skin treated with the ascorbic acid-loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values (P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement (P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid-loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization.
  
  
  CONCLUSIONS
  An ascorbic acid-loaded dissolving microneedle patch produced a significant anti-wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti-wrinkle cosmetic field with patient convenience.
authors.affiliation: Department of Biotechnology, Yonsei University, Seoul, Korea.
authors.forename: C
authors.identifier: http://orcid.org/0000-0002-7024-6378
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Biotechnology, Yonsei University, Seoul, Korea.
authors.forename: H
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Biotechnology, Yonsei University, Seoul, Korea.
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.affiliation: Department of Biotechnology, Yonsei University, Seoul, Korea.
authors.forename: M
authors.initials: M
authors.lastname: Kim
authors.affiliation: Ellead Skin & Bio Research, Ellead Co., Ltd., Gyeonggi, Korea.
authors.forename: H
authors.initials: H
authors.lastname: Kang
authors.affiliation: Ellead Skin & Bio Research, Ellead Co., Ltd., Gyeonggi, Korea.
authors.forename: N
authors.initials: N
authors.lastname: Kim
authors.affiliation: Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
authors.forename: S
authors.initials: S
authors.lastname: An
authors.affiliation: Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
authors.forename: J
authors.initials: J
authors.lastname: Koh
authors.affiliation: Department of Biotechnology, Yonsei University, Seoul, Korea.|JUVIC Biotech. Inc., Seoul, Korea.
authors.forename: H
authors.initials: H
authors.lastname: Jung
mesh_terms: D001205:Ascorbic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D009339:Needles; D010919:Placebos; D015595:Skin Aging; D057968:Transdermal Patch
chemical_list: D010919:Placebos; D001205:Ascorbic Acid
keywords: anti-wrinkle; ascorbic acid; clinical efficacy; dissolving microneedle; skin barrier