PMID- 33228098
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201201
IS  - 1999-4923 (Print)
IS  - 1999-4923 (Electronic)
IS  - 1999-4923 (Linking)
VI  - 12
IP  - 11
DP  - 2020 Nov 19
TI  - The Current Status of Clinical Research Involving Microneedles: A Systematic 
      Review.
LID - 10.3390/pharmaceutics12111113 [doi]
LID - 1113
AB  - In recent years, a number of clinical trials have been published on the efficacy 
      and safety of drug delivery using microneedles (MNs). This review aims to 
      systematically summarize and analyze the current evidence including the clinical 
      effect and safety of MNs. Three electronic databases, including PubMed, were used 
      to search the literature for randomized controlled trials (RCTs) and clinical 
      controlled trials (CCTs) that evaluated the therapeutic efficacy of MNs from 
      their inception to 28 June 2018. Data were extracted according to the 
      characteristics of study subjects; disorder, types, and details of the 
      intervention (MNs) and control groups; outcome measurements; effectiveness; and 
      incidence of adverse events (AEs). Overall, 31 RCTs and seven CCTs met the 
      inclusion criteria. Although MNs were commonly used in skin-related studies, 
      evaluating the effects of MNs was difficult because many studies did not provide 
      adequate comparison values between groups. For osteoporosis treatment, vaccine, 
      and insulin delivery studies, MNs were comparable to or more effective than the 
      gold standard. Regarding the safety of MNs, most AEs reported in each study were 
      minor (grade 1 or 2). A well-designed RCT is necessary to clearly evaluate the 
      effectiveness of MNs in the future.
FAU - Jeong, Seung-Yeon
AU  - Jeong SY
AD  - Department of Anatomy and Acupoint, College of Korean Medicine, Gachon 
      University, Seongnam 13120, Korea.
FAU - Park, Jung-Hwan
AU  - Park JH
AD  - Department of BioNano Technology and Gachon BioNano Research Institute, Gachon 
      University, Seongnam 13120, Korea.
FAU - Lee, Ye-Seul
AU  - Lee YS
AD  - Department of Anatomy and Acupoint, College of Korean Medicine, Gachon 
      University, Seongnam 13120, Korea.
FAU - Kim, Youn-Sub
AU  - Kim YS
AD  - Department of Anatomy and Acupoint, College of Korean Medicine, Gachon 
      University, Seongnam 13120, Korea.
FAU - Park, Ji-Yeun
AU  - Park JY
AD  - College of Korean Medicine, Daejeon University, Daejeon 34520, Korea.
FAU - Kim, Song-Yi
AU  - Kim SY
AUID- ORCID: 0000-0002-3512-2134
AD  - Department of Anatomy and Acupoint, College of Korean Medicine, Gachon 
      University, Seongnam 13120, Korea.
LA  - eng
GR  - 2017R1C1B5018164/This work was supported by the National Research Foundation of 
      Korea (NRF) grant funded by the Korea government (MSIP; Ministry of Science, ICT 
      & Future Planning)/
PT  - Journal Article
PT  - Review
DEP - 20201119
PL  - Switzerland
TA  - Pharmaceutics
JT  - Pharmaceutics
JID - 101534003
PMC - PMC7699365
OTO - NOTNLM
OT  - microneedle
OT  - randomized controlled trial
OT  - research and development
OT  - systematic review
COIS- The authors declare no conflict of interest.
EDAT- 2020/11/25 06:00
MHDA- 2020/11/25 06:01
PMCR- 2020/11/01
CRDT- 2020/11/24 01:07
PHST- 2020/10/10 00:00 [received]
PHST- 2020/11/05 00:00 [revised]
PHST- 2020/11/14 00:00 [accepted]
PHST- 2020/11/24 01:07 [entrez]
PHST- 2020/11/25 06:00 [pubmed]
PHST- 2020/11/25 06:01 [medline]
PHST- 2020/11/01 00:00 [pmc-release]
AID - pharmaceutics12111113 [pii]
AID - pharmaceutics-12-01113 [pii]
AID - 10.3390/pharmaceutics12111113 [doi]
PST - epublish
SO  - Pharmaceutics. 2020 Nov 19;12(11):1113. doi: 10.3390/pharmaceutics12111113.