Clinical endpoints of needle‐free jet injector treatment: An in depth understanding of immediate skin responses

Bik, Liora; Doorn, Martijn van; Boeijink, Neill; Wennekers, Mèdelyn; Meesters, Arne A.; Bloemen, Peter; Hædersdal, Merete; Wolkerstorfer, Albert

doi:10.1002/lsm.23521

Cited by 12 publications

(19 citation statements)

References 20 publications

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“…In contrast, no severe adverse reactions were reported in studies that investigated pneumatic jet injectors. Possibly, this could be related to the tunable settings for pneumatic jet injectors enabling safer and more effective treatment settings based on clinical endpoints, which are not available for spring-loaded injectors [ 57 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of needle-free jet injector-assisted intralesional treatments in dermatology—a systematic review

Bekkers

Bik

Huijstee

et al. 2023

Drug Deliv. and Transl. Res.

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Needle-free jet injectors are used for the intralesional treatment of various dermatological indications. However, a systematic review that evaluates the efficacy and safety of these treatments has not been published. The objectives of this study are to evaluate the efficacy and safety of needle-free jet injections for dermatological indications and to provide evidence-based treatment recommendations. An electronic literature search was conducted in April 2022. Two reviewers independently selected studies based on predefined criteria and performed a methodological quality assessment using the Cochrane Collaborations risk-of-bias 2.0 assessment tool and Newcastle–Ottawa Scale. Thirty-seven articles were included, involving 1911 participants. Dermatological indications included scars, alopecia areata, hyperhidrosis, nail diseases, non-melanoma skin cancer, common warts, local anesthesia, and aesthetic indications. Keloids and other types of scars (hypertrophic, atrophic, and burn scars) were investigated most frequently (n = 7). The included studies reported favorable efficacy and safety outcomes for intralesional jet injector-assisted treatment with triamcinolone acetonide/hexacetonide, 5-fluorouracil, bleomycin, or hyaluronic acid. Two high-quality studies showed good efficacy and tolerability of intralesional jet injections with a combination of 5-fluorouracil and triamcinolone acetonide in hypertrophic scars and with saline in boxcar and rolling acne scars. No serious adverse reactions and good tolerability were reported in the included studies. Overall, the methodological quality of the included studies was low. Limited evidence suggests that needle-free jet injector-assisted intralesional treatment is efficacious and safe for hypertrophic and atrophic acne scars. More well-powered RCTs investigating the efficacy and safety of jet injector treatment in dermatology are warranted to make further evidence-based recommendations. Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of needle-free jet injector-assisted intralesional treatments in dermatology—a systematic review

Bekkers

Bik

Huijstee

et al. 2023

Drug Deliv. and Transl. Res.

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“…EPI was performed perpendicularly on the skin surface with an electronically‐controllable pneumatic jet injector (EnerJet 2.0; PerfAction Technologies Ltd.) at a pressure of 4 bar and an injection volume of 100 μl (device range: 2–6 bar, 50–130 μl, maximum jet stream velocity ≤ 150 m/s) 23 . The selected EPI setting resulted in the highest intradermal drug delivery in a previous study 24 . Injection fluids included a bleomycin 1 U/ml in saline solution ( n = 3; Bleocell; STADApharm GmbH), SAL ( n = 3) and H 2 O ( n = 3).…”

Section: Methodsmentioning

confidence: 99%

“…The selected EPI setting resulted in the highest intradermal drug delivery in a previous study. 24 Injection fluids included a bleomycin 1 U/ml in saline solution (n = 3; Bleocell; STADApharm GmbH), SAL (n = 3) and H 2 O (n = 3). A spring-loaded jet injector (Dermojet; AKRA) with an injection volume of 100 μl of SAL (n = 3) was used for SLI.…”

Section: T a B L E 1 Overview Of Interventionsmentioning

confidence: 99%

Needle‐free jet injection‐induced small‐droplet aerosol formation during intralesional bleomycin therapy

et al. 2021

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Objectives: Needle-free jet injectors are frequently used in dermatological practice. Injection-generated small-droplet aerosols could be harmful upon inhalation when chemotherapeutics, like bleomycin, are used. Here, we aim to explore jet injector-induced small-droplet aerosol formation of bleomycin in relation to air ventilation and to provide safety measures for clinical practice. Materials and Methods: With a professional particle sensor, we measured airborne aerosol particles (0.2-10.0 µm) after electronic pneumatic injection (EPI), springloaded jet injection (SLI), and needle injection (NI) of bleomycin and saline (100 μl) on ex vivo human skin. Three levels of air ventilation were explored: no ventilation, room ventilation, and room ventilation with an additional smoke evacuator. Results: EPI and SLI induced significant small-droplet aerosol formation compared with none after NI (0.2-1.0 µm; no ventilation). The largest bleomycin aerosol generation was observed for the smallest particles (0.2-1.0 µm) with 673.170 (528.802-789.453) aerosol particles/liter air (EPI; no ventilation). Room ventilation and smoke evacuation led to a reduction of ≥99% and 100% of measured aerosols, respectively. Conclusion: Jet injectors generate a high number of small-droplet aerosols, potentially introducing harmful effects to patients and healthcare personnel. Room ventilation and smoke evacuation are effective safety measures when chemotherapeutics are used in clinical practice.

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“…However, the maximum attainable temporal resolution in the present imaging techniques for skin tissue visualization is about 1.5–2 ms [ 47 ], which is not adequate for the real-time visualization of a fluid injected by an NFJIS into the skin tissue matrix. Hence, in majority of the studies, in vitro media like agarose, gelatin, or polyacrylamide gels [ 6 , 7 , 13 , 21 , 36 , 38 , 41 , 43 , 45 , 46 , 48 – 55 ] were used for investigating the dynamic injection characteristics of an NFJIS, while the ex vivo studies were performed via dissection after the injection [ 10 , 11 , 15 , 37 , 38 , 56 – 59 ] or by micro-computed tomography [ 9 ] or X-ray [ 38 , 60 ] imaging techniques. In vitro models are indispensable tools in drug delivery applications for investigating the effect of individual parameters and to tune the independent and alternative parameters.…”

Section: Introductionmentioning

confidence: 99%

Dynamic interaction of injected liquid jet with skin layer interfaces revealed by microsecond imaging of optically cleared ex vivo skin tissue model

et al. 2023

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Background Needle-free jet injection (NFJI) systems enable a controlled and targeted delivery of drugs into skin tissue. However, a scarce understanding of their underlying mechanisms has been a major deterrent to the development of an efficient system. Primarily, the lack of a suitable visualization technique that could capture the dynamics of the injected fluid–tissue interaction with a microsecond range temporal resolution has emerged as a main limitation. A conventional needle-free injection system may inject the fluids within a few milliseconds and may need a temporal resolution in the microsecond range for obtaining the required images. However, the presently available imaging techniques for skin tissue visualization fail to achieve these required spatial and temporal resolutions. Previous studies on injected fluid–tissue interaction dynamics were conducted using in vitro media with a stiffness similar to that of skin tissue. However, these media are poor substitutes for real skin tissue, and the need for an imaging technique having ex vivo or in vivo imaging capability has been echoed in the previous reports. Methods A near-infrared imaging technique that utilizes the optical absorption and fluorescence emission of indocyanine green dye, coupled with a tissue clearing technique, was developed for visualizing a NFJI in an ex vivo porcine skin tissue. Results The optimal imaging conditions obtained by considering the optical properties of the developed system and mechanical properties of the cleared ex vivo samples are presented. Crucial information on the dynamic interaction of the injected liquid jet with the ex vivo skin tissue layers and their interfaces could be obtained. Conclusions The reported technique can be instrumental for understanding the injection mechanism and for the development of an efficient transdermal NFJI system as well.

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Clinical endpoints of needle‐free jet injector treatment: An in depth understanding of immediate skin responses

Cited by 12 publications

References 20 publications

Efficacy and safety of needle-free jet injector-assisted intralesional treatments in dermatology—a systematic review

Efficacy and safety of needle-free jet injector-assisted intralesional treatments in dermatology—a systematic review

Needle‐free jet injection‐induced small‐droplet aerosol formation during intralesional bleomycin therapy

Dynamic interaction of injected liquid jet with skin layer interfaces revealed by microsecond imaging of optically cleared ex vivo skin tissue model

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