Clinical endpoints of needle-free jet injector treatment: An in depth understanding of immediate skin responses
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Clinical endpoints of needle-free jet injector treatment : An in depth understanding of immediate skin responses. / Bik, Liora; van Doorn, Martijn B. A.; Boeijink, Neill; Wennekers, Medelyn; Meesters, Arne A.; Bloemen, Peter; Haedersdal, Merete; Wolkerstorfer, Albert.
I: Lasers in Surgery and Medicine, Bind 54, Nr. 5, 07.2022, s. 693-701.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Clinical endpoints of needle-free jet injector treatment
T2 - An in depth understanding of immediate skin responses
AU - Bik, Liora
AU - van Doorn, Martijn B. A.
AU - Boeijink, Neill
AU - Wennekers, Medelyn
AU - Meesters, Arne A.
AU - Bloemen, Peter
AU - Haedersdal, Merete
AU - Wolkerstorfer, Albert
PY - 2022/7
Y1 - 2022/7
N2 - Objectives Needle-free jet injectors have been used in dermatological practice for many years. However, predefined clinical endpoints that guide physicians to choose optimal device settings have not been clearly defined. Here, we evaluate immediate skin responses as clinical endpoints for needle-free jet injector treatments. Methods We injected methylene blue in ex vivo human skin using an electronically-controllable pneumatic injector (EPI; 3-6 bar, 50-130 mu l; n = 63), and a spring-loaded jet injector (SLI) with fixed settings (100 mu l; n = 9). We measured the immediate skin papule (3D-camera), residual surface fluid (pipette), dermal dye distribution by estimating depth and width, and subcutaneous dye deposition. Results EPI with 4 bar and 100 mu l resulted in the largest skin papule of 48.7 mm(3) (35.4-62.6 mm(3)) and widest dermal distribution of 8.0 mm (5.5-9.0 mm) compared to EPI with 6 bar and 100 mu l (p < 0.001, p = 0.018, respectively). The skin papule volume showed a significant moderate to high positive correlation with the width and depth of dye distribution in the dermis (r(s) = 0.63, r(s) = 0.58, respectively; p < 0.001 for both correlations). SLI showed high variability for all outcome measures. Finally, a trend was observed that a small skin papule (
AB - Objectives Needle-free jet injectors have been used in dermatological practice for many years. However, predefined clinical endpoints that guide physicians to choose optimal device settings have not been clearly defined. Here, we evaluate immediate skin responses as clinical endpoints for needle-free jet injector treatments. Methods We injected methylene blue in ex vivo human skin using an electronically-controllable pneumatic injector (EPI; 3-6 bar, 50-130 mu l; n = 63), and a spring-loaded jet injector (SLI) with fixed settings (100 mu l; n = 9). We measured the immediate skin papule (3D-camera), residual surface fluid (pipette), dermal dye distribution by estimating depth and width, and subcutaneous dye deposition. Results EPI with 4 bar and 100 mu l resulted in the largest skin papule of 48.7 mm(3) (35.4-62.6 mm(3)) and widest dermal distribution of 8.0 mm (5.5-9.0 mm) compared to EPI with 6 bar and 100 mu l (p < 0.001, p = 0.018, respectively). The skin papule volume showed a significant moderate to high positive correlation with the width and depth of dye distribution in the dermis (r(s) = 0.63, r(s) = 0.58, respectively; p < 0.001 for both correlations). SLI showed high variability for all outcome measures. Finally, a trend was observed that a small skin papule (
KW - dermatology
KW - drug delivery
KW - injection
KW - intralesional
KW - jet injection
KW - needle-free injection
KW - pneumatic injection
U2 - 10.1002/lsm.23521
DO - 10.1002/lsm.23521
M3 - Journal article
C2 - 35067934
VL - 54
SP - 693
EP - 701
JO - Lasers in Surgery and Medicine
JF - Lasers in Surgery and Medicine
SN - 0196-8092
IS - 5
ER -
ID: 314437350