PMID- 32103450
OWN - NLM
STAT- MEDLINE
DCOM- 20210702
LR  - 20240329
IS  - 2190-3948 (Electronic)
IS  - 2190-393X (Print)
IS  - 2190-393X (Linking)
VI  - 10
IP  - 3
DP  - 2020 Jun
TI  - Evaluation of the clinical impact of repeat application of hydrogel-forming 
      microneedle array patches.
PG  - 690-705
LID - 10.1007/s13346-020-00727-2 [doi]
AB  - Hydrogel-forming microneedle array patches (MAPs) have been proposed as viable 
      clinical tools for patient monitoring purposes, providing an alternative to 
      traditional methods of sample acquisition, such as venepuncture and intradermal 
      sampling. They are also undergoing investigation in the management of 
      non-melanoma skin cancers. In contrast to drug or vaccine delivery, when only a 
      small number of MAP applications would be required, hydrogel MAPs utilised for 
      sampling purposes or for tumour eradication would necessitate regular, repeat 
      applications. Therefore, the current study was designed to address one of the key 
      translational aspects of MAP development, namely patient safety. We demonstrate, 
      for the first time in human volunteers, that repeat MAP application and wear does 
      not lead to prolonged skin reactions or prolonged disruption of skin barrier 
      function. Importantly, concentrations of specific systemic biomarkers of 
      inflammation (C-reactive protein (CRP); tumour necrosis factor-alpha (TNF-alpha)); 
      infection (interleukin-1beta (IL-1beta); allergy (immunoglobulin E (IgE)) and immunity 
      (immunoglobulin G (IgG)) were all recorded over the course of this fixed study 
      period. No biomarker concentrations above the normal, documented adult ranges 
      were recorded over the course of the study, indicating that no systemic reactions 
      had been initiated in volunteers. Building upon the results of this study, which 
      serve to highlight the safety of our hydrogel MAP, we are actively working 
      towards CE marking of our MAP technology as a medical device.
FAU - Al-Kasasbeh, Rehan
AU  - Al-Kasasbeh R
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
FAU - Brady, Aaron J
AU  - Brady AJ
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
AD  - Belfast Health and Social Care Trust, Belfast City Hospital, 51 Lisburn Road, 
      Belfast, BT9 7AB, UK.
FAU - Courtenay, Aaron J
AU  - Courtenay AJ
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
FAU - Larraneta, Eneko
AU  - Larraneta E
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
FAU - McCrudden, Maeliosa T C
AU  - McCrudden MTC
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
FAU - O'Kane, Donal
AU  - O'Kane D
AD  - Belfast Health and Social Care Trust, Royal Victoria Hospital, 274 Grosvenor 
      Road, Belfast, BT12 6BA, UK.
FAU - Liggett, Stephen
AU  - Liggett S
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK.
FAU - Donnelly, Ryan F
AU  - Donnelly RF
AD  - School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 
      7BL, UK. r.donnelly@qub.ac.uk.
LA  - eng
GR  - WT_/Wellcome Trust/United Kingdom
GR  - BB/K020234/1/BB_/Biotechnology and Biological Sciences Research Council/United 
      Kingdom
GR  - WT094085MA/WT_/Wellcome Trust/United Kingdom
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Drug Deliv Transl Res
JT  - Drug delivery and translational research
JID - 101540061
RN  - 0 (Biomarkers)
RN  - 0 (Hydrogels)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Biomarkers/*analysis
MH  - Equipment Design
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Hydrogels
MH  - Male
MH  - Microinjections/adverse effects/*instrumentation
MH  - Needles
MH  - Transdermal Patch/adverse effects
PMC - PMC7228965
OTO - NOTNLM
OT  - Biomarkers
OT  - Clinical translation
OT  - Hydrogels
OT  - Microneedle array patches
OT  - Microneedles
OT  - Safety
OT  - Skin barrier
COIS- Ryan Donnelly is an inventor of patents that have been licenced to companies 
      developing microneedle-based products and is a paid advisor to companies 
      developing microneedle-based products. The resulting potential conflict of 
      interest has been disclosed and is managed by Queen's University Belfast. The 
      companies had no role in the design of the study, in the collection, analyses or 
      interpretation of data, in the writing of the manuscript or in the decision to 
      publish the results.
EDAT- 2020/02/28 06:00
MHDA- 2021/07/03 06:00
PMCR- 2020/02/26
CRDT- 2020/02/28 06:00
PHST- 2020/02/28 06:00 [pubmed]
PHST- 2021/07/03 06:00 [medline]
PHST- 2020/02/28 06:00 [entrez]
PHST- 2020/02/26 00:00 [pmc-release]
AID - 10.1007/s13346-020-00727-2 [pii]
AID - 727 [pii]
AID - 10.1007/s13346-020-00727-2 [doi]
PST - ppublish
SO  - Drug Deliv Transl Res. 2020 Jun;10(3):690-705. doi: 10.1007/s13346-020-00727-2.