Publications & Reviews
Human studies
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Influenza
- Van Damme P, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009; 27:454-9;
- Della Cioppa G, et al. A dose-range study in older adults to compare the safety and immunogenicity profiles of MF59 adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccines Immunother 2014; 10:6, 1-10. Read full article.
- Levin Y, Kochba E, Kenney R. Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: Are all delivery methods the same? Vaccine 2014; 34:4249-52;
- Hung IF et al . Quantitative and qualitative analysis of antibody response after dose sparing intradermal 2009 H1N1 vaccination. Vaccine 30 (2012) 2707– 2708. Read full article.
- Hung IF, et al. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012; 30:6427-35;
- Levin Y. et al. A phase 1, open-label, randomized study to compare the immunogenicity and safety of different administration routes and doses of virosomal influenza vaccine in elderly. Vaccine 34 (2016) 5262–5272. Read full article.
- Carter et al. The adjuvant GLA-AF enhances human intradermal vaccine responses. Sci. Adv. 2018; 4. eaas9930. Read full article.
- El Sahly HM, et al. Topical Imiquimod Does Not Provide an Adjuvant Effect When Administered with Inactivated Influenza A/H5N1 Vaccine in Healthy Young Adults, The Journal of Infectious Diseases, Volume 224, Issue 10, 15 November 2021, Pages 1712–1719.
- Van Damme P, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009; 27:454-9;
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Polio
- Stephanie B. Troy et al. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. (2015) 211 (12): 1969-1976. Read full article..
- Anand A et al. Early priming with inactivated poliovirus vaccine (IPV) andintradermal fractional dose IPV administered by a microneedledevice: A randomized controlled trial. Vaccine 33 (2015) 6816–6822
- Stephanie B. Troy et al. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. (2015) 211 (12): 1969-1976. Read full article..
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Zoster
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Nakamura-Nishimura Y, et al. Immunogenicity of varicella-zoster virus vaccine by different routes of administration: Comparable vaccination efficacy of one-fifth dose intradermal vaccination to conventional subcutaneous vaccination. J Dermatol Sci. 2022;106(2):86-92.
- Chan R Beals et al. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22
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HBV
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Ko KL, et al. Clinical trial: intra dermal hepatitis B vaccination with topical imiquimod versus intramuscular hepatitis B vaccination in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2022;56(2):301-309.
https://pubmed.ncbi.nlm.nih.gov/35546255/ - Hung IF et al. A Double-blind, Randomized Phase 2 Controlled Trial of Intradermal Hepatitis B Vaccination With a Topical Toll-like Receptor 7 Agonist Imiquimod, in Patients on Dialysis. Clin Infect Dis. 2020 Jun 18;ciaa804. doi: 10.1093/cid/ciaa804. Online ahead of print.
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CMV
- Adler SP et al. Phase 1 Clinical Trial of a Conditionally Replication Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. The Journal of Infectious Diseases® 2019;220:411–9. Read full article.
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COVID
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Leung D, et al. Safety and immunogenicity of 3 doses of BNT162b2 and CoronaVac in children and adults with inborn errors of immunity. Front Immunol. 2022;13:982155. Published 2022 Sep 20. doi:10.3389/fimmu.2022.982155.
Read full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC9530261/pdf/fimmu-13-982155.pdf -
Jaime S, et al. Superior antibody and membrane protein-specific T cell responses to CoronaVac by intradermal versus intramuscular routes in adolescents. medRxiv 2023.04.05.23288005; doi: https://doi.org/10.1101/2023.04.05.23288005.
Read full article: https://pubmed.ncbi.nlm.nih.gov/38085470/ - Fan S, et al. Ameliorated immunity elicited by intradermal inoculation in individuals vaccinated with inactivated SARS-CoV-2 vaccine. Vaccine. 2021 Nov 26;39(48):6980-6983. Read full article.
- Levin Y. Peer review of: Immunogenicity and reactogenicity after booster dose with AZD1222 via intradermal route among adult who had received CoronaVac, Qeios, December 22, 2021. Read full article.
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Review
- Levin Y. et al. Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future. Human Vaccines & Immunotherapeutics 11:4, 991–997; April 2015
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Dengue
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Miauton A, et al. Safety and immunogenicity of a synthetic nanoparticle-based, T cell priming peptide vaccine against dengue in healthy adults in Switzerland: a double-blind, randomized, vehicle-controlled, phase 1 study. EBioMedicine. 2024;99:104922. doi:10.1016/j.ebiom.2023.104922.
Read full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC10776924/pdf/main.pdf
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Chlamydia
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Pollock KM, et al. An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial. Lancet Infect Dis. Published online April 10, 2024. doi:10.1016/S1473-3099(24)00147-6.
Read the article: https://pubmed.ncbi.nlm.nih.gov/38615673/
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PPD
- Lee HJ et.al Safety and efficacy of tuberculin skin testing with microneedle MicronJet600 in healthy adults Int J Tuberc Lung Dis 20(4):500–504 Q 2016. Read full article.
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Insulin
- Kochba E. et al. Improved Insulin Pharmacokinetics Using a Novel Microneedle Device for Intradermal Delivery in Patients with Type 2 Diabetes. Diabetes Technology & Therapeutics 2016; 18(9). Read full article.
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Adalimumab
- Jacobse J et al. Comprehensive evaluation of microneedle-based intradermal adalimumab delivery versus subcutaneous administration: results of a randomized controlled trial. Br J Clin Pharmacol. 2021 Jan 5. doi: 10.1111/bcp.14729. Epub ahead of print. PMID: 33403697. Read full article.
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T1DM
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Hanna SJ, et al. Single-cell RNAseq identifies clonally expanded antigen-specific T-cells following intradermal injection of gold nanoparticles loaded with diabetes autoantigen in humans. Front Immunol. 2023;14:1276255. Published 2023 Oct 16. doi:10.3389/fimmu.2023.1276255.
Read full article : https://pmc.ncbi.nlm.nih.gov/articles/PMC10613693/pdf/fimmu-14-1276255.pdf - Nikolic T. et al. Safety and feasibility of intradermal injection with tolerogenic dendritic cells pulsed with proinsulin peptide—for type 1 diabetes. Lancet Diabetes Endocrinol. 2020 Jun;8(6):470-472. doi: 10.1016/S2213-8587(20)30104-2. Epub 2020 May 5. PMID: 32723484. Read full article (The Lancet)
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Peanut allergy
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Ferslew BC, et al. Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. Allergy. 2024;79(2):456-470. doi:10.1111/all.15931
https://pubmed.ncbi.nlm.nih.gov/38010254
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Cancer
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Somaiah N, et al. A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. Oncoimmunology. 2020;9(1):1847846. Published 2020 Nov 19. doi:10.1080/2162402X.2020.1847846.
Read full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC7714520/pdf/KONI_9_1847846.pdf -
Somaiah N, et al. First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1. Clin Cancer Res. 2019;25(19):5808-5817. doi:10.1158/1078-0432.CCR-19-1025.
Read full article: https://watermark02.silverchair.com/5808.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA0owggNGBgkqhkiG9w0BBwagggM3MIIDMwIBADCCAywGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQM-h9xQo04fU8wYEr_AgEQgIIC_W9DSkrxW9TTZBXP40qk9LTKDZYq9s15Id6xoboK1zzg6zv
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Mesotherapy
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Dell'Avanzato R, et al. Facial rejuvenation using a microneedle-based device with a revitalizing solution and free hyaluronic acid. J Cosmet Dermatol. 2021 Nov;20(11):3701-3703.
Read full article: https://www.researchgate.net/publication/355802565_Facial_rejuvenation_using_a_microneedle-based_device_with_a_revitalizing_solution_and_free_hyaluronic_acid -
Boca A, et al. Evaluation of the Performance and Safety of a New Micro-Needle Technology in Comparison with the Classic Needle on the Antiaging Effects of a Biorevitalizing Solution: A Randomized Split Face/Neck Study. J Cosmet Dermatol. 2024;23(12):3974-3985. doi:10.1111/jocd.16547.
Read full article: https://pubmed.ncbi.nlm.nih.gov/39356623/ - Dell'Avanzato R, et al. Facial rejuvenation using a microneedle-based device with a revitalizing solution and free hyaluronic acid. J Cosmet Dermatol. 2021 Nov;20(11):3701-3703. Read full article
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Wrinkles
- Diaspro A, Silenzi S. Microneedle for Botulinum Toxin: A Randomized, Case-control, Single-blind Study to Assess Clinical Efficacy and Patient Satisfaction. Plast Reconstr Surg Glob Open. 2025;13(3):e6610. Published 2025 Mar 17. doi:10.1097/GOX.0000000000006610.
Read full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC11913416/pdf/gox-13-e6610.pdf
- Diaspro A, Silenzi S. Microneedle for Botulinum Toxin: A Randomized, Case-control, Single-blind Study to Assess Clinical Efficacy and Patient Satisfaction. Plast Reconstr Surg Glob Open. 2025;13(3):e6610. Published 2025 Mar 17. doi:10.1097/GOX.0000000000006610.
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Local Anasthesia
- Rzhevskiy A, Popov A, Pavlov C, Anissimov Y, Zvyagin A, Levin Y, Kochba E. Intradermal injection of lidocaine with a microneedle device to provide rapid local anaesthesia for peripheral intravenous cannulation: A randomised open-label placebo-controlled clinical trial. PLoS One. 2022 Jan 31;17(1):e0261641. doi: 10.1371/journal.pone.0261641. PMID: 35100279; PMCID: PMC8803196. Read full article
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Blepharoplasty
- Dell’Avanzato R, Agnelli B, Cambiaso-Daniel J, Gatti J, Gualdi A.
Can local infiltration influence postoperative recovery in upper blepharoplasty? A case series study on two different infiltration methods.
Facial Plast Surg. 2023;39(4):[pages if needed]. doi:10.1055/a-2098-6188:
https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-2098-6188
- Dell’Avanzato R, Agnelli B, Cambiaso-Daniel J, Gatti J, Gualdi A.
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Other
- Tatovic D. et al. Fine-Needle Aspiration Biopsy of the Lymph Node: A Novel Tool for the Monitoring of Immune Responses after Skin Antigen Delivery. J Immunol. 2015 Jul 1;195(1):386-92. Read full article.
- Polomska A et al. Development and Clinical Validation of the LymphMonitor Technology to Quantitatively Assess Lymphatic Function. Diagnostics (Basel). 2021 Oct 12;11(10):1873. doi: 10.3390/diagnostics11101873. PMID: 34679571; PMCID: PMC8534490. Read full article.
- Tatovic D. et al. Fine-Needle Aspiration Biopsy of the Lymph Node: A Novel Tool for the Monitoring of Immune Responses after Skin Antigen Delivery. J Immunol. 2015 Jul 1;195(1):386-92. Read full article.
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Pre-Clinical studies
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Volokhov DV, et al. Robust humoral immune response against rabies virus in rabbits and guinea pigs immunized with plasmid DNA vectors encoding rabies virus glycoproteins - An approach to the production of polyclonal antibody reagents. Mol Cell Probes. 2022;64:101833. doi:10.1016/j.mcp.2022.101833
https://pubmed.ncbi.nlm.nih.gov/35691598/ -
Lescan M, et al. De Novo Synthesis of Elastin by Exogenous Delivery of Synthetic Modified mRNA into Skin and Elastin-Deficient Cells. Mol Ther Nucleic Acids. 2018;11:475-484. doi:10.1016/j.omtn.2018.03.013.
Read full publication: https://pmc.ncbi.nlm.nih.gov/articles/PMC5992474/pdf/main.pdf -
Darade AR, et al. Effect of mRNA Delivery Modality and Formulation on Cutaneous mRNA Distribution and Downstream eGFP Expression. Pharmaceutics. 2022;14(1):151. Published 2022 Jan 8. doi:10.3390/pharmaceutics14010151.
Read full article: https://pmc.ncbi.nlm.nih.gov/articles/PMC8780332/pdf/pharmaceutics-14-00151.pdf -
Amano T, et al. Controllable self-replicating RNA vaccine delivered intradermally elicits predominantly cellular immunity. Preprint. bioRxiv. 2022;2022.09.05.506686. Published 2022 Sep 6. doi:10.1101/2022.09.05.506686.
Read full article: https://www.biorxiv.org/content/10.1101/2022.09.05.506686v1.full.pdf - Yang YS, et al. Suppression of heterotopic ossification in fibrodysplasia ossificans progressiva using AAV gene delivery. Nat Commun. 2022;13(1):6175. Published 2022 Oct 19. doi:10.1038/s41467-022-33956-9.
Read full article https://pmc.ncbi.nlm.nih.gov/articles/PMC9579182/pdf/41467_2022_Article_33956.pdf - Futaki M, et al. Effects of Intradermal Administration Volume Using a Hollow Microneedle on the Pharmacokinetics of Fluorescein Isothiocyanate Dextran (M.W. 4,000). Pharm Res. 2023;40(8):1953-1963. doi:10.1007/s11095-023-03529-6.
Read more: https://pubmed.ncbi.nlm.nih.gov/37165148/ - Dul M. et al. Hydrodynamic gene delivery in human skin using a hollow microneedle device. J Control Release. 2017 Nov 10;265:120-131
- Kouiavskaia D. et al. Intradermal Inactivated Poliovirus Vaccine: A Preclinical Dose-Finding Study. J Infect Dis. 2015 May 1;211(9):1447-50. Read full article.
- Wang Y. et al. Skin Vaccination against Rotavirus Using Microneedles: Proof of Concept in Gnotobiotic Piglets. PLoS One. 2016 Nov 8;11(11). Read full article.
- Heine SJ. et al. Intradermal delivery of Shigella IpaB and IpaD type III secretion proteins: kinetics of cell recruitment and antigen uptake, mucosal and systemic immunity, and protection across serotypes. J Immunol. 2014 Feb 15;192(4):1630-40https://pubmed.ncbi.nlm.nih.gov/24453241/
Read full article. - Golombek S. et al. Intradermal Delivery of Synthetic mRNA Using Hollow Microneedles for Efficient and Rapid Production of Exogenous Proteins in Skin. Molecular Therapy Nucleic Acids Volume 11, 1 June 2018, Pages 382-392. Read full article.
- Polomska AK. et al. Minimally invasive method for the point-of-care quantification of lymphatic vessel function. JCI Insight.2019 Feb 21;4(4). Read full article
- Di Blasio S. et. al. The tumour microenvironment shapes dendritic cell plasticity in a human organotypic melanoma culture. BioRxiv. 2019. Read full article.
- Dul M. et al. Conjugation of a peptide autoantigen to gold nanoparticles for intradermally administered antigen specific immunotherapy. International Journal of Pharmaceutics Volume 562, 1 May 2019, Pages 303-312
- Singh RK. et al. Using gold nanoparticles for enhanced intradermal delivery of poorly soluble auto-antigenic peptides. Nanomedicine: Nanotechnology, Biology, and Medicine 32 (2021) 102321
- Rentzsch M. et al. Specific Protein Antigen Delivery to Human Langerhans Cells in Intact Skin. Front Immunol. 2021 Oct 21;12:732298. Read full article.
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Zuo W, et al. Dose-Sparing Intradermal DTaP-sIPV Immunization With a Hollow Microneedle Leads to Superior Immune Responses. Front Microbiol. 2021 Oct 25 ;12:757375.doi:10.3389/fmicb.2021.757375. PMID: 34759909; PMCID: PMC8573275. Read full article.
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The clinical results published herein were conducted to demonstrate clinical benefits and were not reviewed by any regulatory authorities.