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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 et al.

In: Lasers in surgery and medicine, Vol. 54, No. 5, 07.2022, p. 693-701.

Research output: Contribution to journal › Article › Academic › peer-review

Harvard

Bik, L, van Doorn, MBA, Boeijink, N, Wennekers, M, Meesters, AA, Bloemen, P, Haedersdal, M & Wolkerstorfer, A 2022, 'Clinical endpoints of needle-free jet injector treatment: An in depth understanding of immediate skin responses', Lasers in surgery and medicine, vol. 54, no. 5, pp. 693-701. https://doi.org/10.1002/lsm.23521

APA

Bik, L., van Doorn, M. B. A., Boeijink, N., Wennekers, M., Meesters, A. A., Bloemen, P., Haedersdal, M., & Wolkerstorfer, A. (2022). Clinical endpoints of needle-free jet injector treatment: An in depth understanding of immediate skin responses. Lasers in surgery and medicine, 54(5), 693-701. https://doi.org/10.1002/lsm.23521

Vancouver

Bik L, van Doorn MBA, Boeijink N, Wennekers M, Meesters AA, Bloemen P et al. Clinical endpoints of needle-free jet injector treatment: An in depth understanding of immediate skin responses. Lasers in surgery and medicine. 2022 Jul;54(5):693-701. Epub 2022. doi: 10.1002/lsm.23521

Author

Bik, Liora ; van Doorn, Martijn B. A. ; Boeijink, Neill et al. / Clinical endpoints of needle-free jet injector treatment : An in depth understanding of immediate skin responses. In: Lasers in surgery and medicine. 2022 ; Vol. 54, No. 5. pp. 693-701.

BibTeX

@article{1a0adaa7411d4a57b39ee2da472ba4f5,
title = "Clinical endpoints of needle-free jet injector treatment: An in depth understanding of immediate skin responses",
abstract = "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 µl; n = 63), and a spring-loaded jet injector (SLI) with fixed settings (100 µl; 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 µl resulted in the largest skin papule of 48.7 mm3 (35.4–62.6 mm3) and widest dermal distribution of 8.0 mm (5.5–9.0 mm) compared to EPI with 6 bar and 100 µl (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 (rs = 0.63, rs = 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 (≤7 mm) and little residual surface fluid (≤10% of injection volume) were warning signs for subcutaneous deposition. Conclusions: The immediate skin papule and residual surface fluid correspond with dermal drug deposition and are relevant clinical endpoints for needle-free jet injector treatments in dermatological practice.",
keywords = "dermatology, drug delivery, injection, intralesional, jet injection, needle-free injection, pneumatic injection",
author = "Liora Bik and {van Doorn}, {Martijn B. A.} and Neill Boeijink and Medelyn Wennekers and Meesters, {Arne A.} and Peter Bloemen and Merete Haedersdal and Albert Wolkerstorfer",
note = "Funding Information: We thank J. Florisson and G. Krebbers for their contribution to this study. Publisher Copyright: {\textcopyright} 2022 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.",
year = "2022",
month = jul,
doi = "10.1002/lsm.23521",
language = "English",
volume = "54",
pages = "693--701",
journal = "Lasers in surgery and medicine",
issn = "0196-8092",
publisher = "Wiley-Liss Inc.",
number = "5",

}

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

N1 - Funding Information: We thank J. Florisson and G. Krebbers for their contribution to this study. Publisher Copyright: © 2022 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

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 µl; n = 63), and a spring-loaded jet injector (SLI) with fixed settings (100 µl; 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 µl resulted in the largest skin papule of 48.7 mm3 (35.4–62.6 mm3) and widest dermal distribution of 8.0 mm (5.5–9.0 mm) compared to EPI with 6 bar and 100 µl (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 (rs = 0.63, rs = 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 (≤7 mm) and little residual surface fluid (≤10% of injection volume) were warning signs for subcutaneous deposition. Conclusions: The immediate skin papule and residual surface fluid correspond with dermal drug deposition and are relevant clinical endpoints for needle-free jet injector treatments in dermatological practice.

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 µl; n = 63), and a spring-loaded jet injector (SLI) with fixed settings (100 µl; 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 µl resulted in the largest skin papule of 48.7 mm3 (35.4–62.6 mm3) and widest dermal distribution of 8.0 mm (5.5–9.0 mm) compared to EPI with 6 bar and 100 µl (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 (rs = 0.63, rs = 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 (≤7 mm) and little residual surface fluid (≤10% of injection volume) were warning signs for subcutaneous deposition. Conclusions: The immediate skin papule and residual surface fluid correspond with dermal drug deposition and are relevant clinical endpoints for needle-free jet injector treatments in dermatological practice.

KW - dermatology

KW - drug delivery

KW - injection

KW - intralesional

KW - jet injection

KW - needle-free injection

KW - pneumatic injection

UR - http://www.scopus.com/inward/record.url?scp=85123469356&partnerID=8YFLogxK

U2 - 10.1002/lsm.23521

DO - 10.1002/lsm.23521

M3 - 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: 21577020