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Table 6 MN product clinical trials completed (Source: ClinicalTrials.gov)

From: Emerging era of microneedle array for pharmaceutical and biomedical applications: recent advances and toxicological perspectives

Sr. No. Study title Intervention Condition Status Year
1. 2010/2011 trivalent influenza vaccination Biological: TIV 2010/2011 influenza vaccine
Biological: INT
Influenza Completed 2011
2. A study to assess the safety and efficacy of an MNs device for local anesthesia Device: MicronJet Local anesthesia
Intradermal injections
Completed 2013
3. Optimization of tuberculosis intradermal skin test Medical device: MNs BD 1.5 mm 30G
Drug: Tubertest®: tuberculin (purified protein derivative)
Device: medical device: lance 26G X 16 mm
Drug: Tubertest®
Healthy volunteers Completed 2013
4. A pilot study to assess the safety, PK and PD of insulin injected via MicronJet or conventional needle Device: MicronJet Intradermal injections Completed 2013
5. A study to assess the safety and efficacy of an MNs device for local anesthesia Device: Micron Jet Local anesthesia
Intradermal injections
Completed 2013
6. Dose sparing intradermal S-OIV H1N1 influenza vaccination device Biological: S-OIV H1N1 vaccine Influenza infection Completed 2013
7. Routes of immunization and flu immune responses Biological: INTANZA®15
Biological: Vaxigrip®
Biological: INTANZA®15 T
Influenza Completed 2013
8. A pilot study to evaluate the safety and immunogenicity of low dose flu vaccines Biological: Flu Vaccine (FLUARIX®) Influenza Completed 2013
9. Insulin delivery using MNs in type 1 diabetes Device: MNs
Device: Subcutaneous insulin catheter
Type 1 diabetes mellitus Completed 2014
10. Safety demonstration of MN insertion Device: Gold- or silver-coated, or uncoated nickel MNs Allergic reaction to nickel Completed 2016
11. The use of MNs in photodynamic therapy Device: MNs
Drug: Aminolevulinic Acid
Radiation: Blue light
Actinic keratosis Completed 2017
12. Site selection for intracutaneous saline delivery Device: Injection to deltoid
Device: Injection to forearm
Device: Injection to thigh
• Intracutaneous drug delivery Completed 2017
13. Intracutaneous delivery of varied dose volumes of saline Device: FLUGEN 101.2 device Influenza Completed 2017
14. The use of MNs with topical botulinum toxin for the treatment of palmar hyperhidrosis Device: MNs
Device: Sham MNs
Drug: Botulinum Toxin Type A
Other: Saline
Hyperhidrosis Completed 2017
15. Fractional MNs radiofrequency and I Botulinum Toxin A for primary axillary hyperhidrosis Device: Fractional MNs Radiofrequency Primary axillary hyperhidrosis Completed 2017
16. Suprachoroidal injection of triamcinolone acetonide in subjects with macular edema following non-infectious uveitis Drug: 4 mg CLS-TA
Drug: 0.8 mg CLS-TA
Uveitis, macular edema
Uveitis
Completed 2017
17. Glucose measurement using MN patches Device: MNs patch
Device: Intravenous (IV) catheter
Device: Lancet
Diabetes Completed 2018
18. Suprachoroidal injection of CLS-TA alone or with aflibercept in subjects with diabetic macular edema Drug: IVT Aflibercept
Drug: SC CLS-TA
Diabetic macular edema Completed 2018
19. A split-mouth trial to compare MNs vs. standard needles in dental anesthetic delivery Device: MNs Device (Experimental)
Device: 30-gauge Short Hypodermic Needle
Dental pain
Anesthesia
Completed 2018
20. The effect of MN pretreatment on topical anesthesia Device: Sham MNs
Roller Device: MNs Roller
Pain Completed 2018
21. MNs lesion preparation prior to ALA-PDT for AK on face Drug: Aminolevulinic acid
Drug: Topical Solution Vehicle
Device: IBL 10 mW
Actinic keratosis Completed 2018
22. Clinical evaluation of healthy subjects receiving intradermal saline using the MN adapter (Model UAR-2S) Device: MNs Adapter (Model UAR-2S)
Device: Hypodermic needle + syringe
Intradermal injection Completed 2018
23. Safety and efficacy of ZP-zolmitriptan intracutaneous MN systems for the acute treatment of migraine Drug: ZP-Zolmitriptan
Drug: Placebo
Acute migraine Completed 2018
24. Suprachoroidal injection of CLS-TA in subjects with macular edema associated with non-infectious uveitis. Drug: 4 mg CLS-TA Suprachoriodal Injection
Drug: Sham Procedure
Uveitis, posterior uveitis Completed 2018
25. A study to evaluate the long-term safety of M207 in the acute treatment of migraine Drug: M207 MNs System Migraine Completed 2019
26. The use of MNs to expedite treatment time in photodynamic therapy Device: MN roller
Drug: Aminolevulinic acid
Radiation: Blue Light
Keratosis, actinic Completed 2019
27. A study of the use of MN patches to deliver topical lidocaine in the oral cavity Device: MNs Patch
Device: Patch with no MNs
Topical anesthesia Completed 2019
28. Inactivated influenza vaccine delivered by MN patch or by hypodermic needle Biological: Inactivated influenza vaccine
Other: Placeb
Influenza Completed 2019
29. Safety study of suprachoroidal triamcinolone acetonide via MN to treat uveitis Drug: Triamcinolone acetonide Uveitis, intermediate uveitis, posterior uveitis Completed 2019
30. Extension study of patients with non-infectious uveitis who participated in CLS1001-301 Drug: 4 mg CLS-TA Suprachoriodal Injection Uveitis
Posterior uveitis
Completed 2019
31. Suprachoroidal injection of CLS-TA in subjects with non-infectious uveitis Combination Product: 4 mg CLS-TA Uveitis
Posterior uveitis
Completed 2019
32. Analysis of noninvasively collected MN device samples from mild plaque psoriasis for use in transcriptomics profiling Device: MN device Psoriasis vulgaris Completed 2019
33. Comparison of 1,550-nm laser and fractional radiofrequency MNs for the treatment of acne scars in ethnic skin Device: Fraxel Restore
Device: Fractora
Acne scars Completed 2019
34. Minimally invasive sensing of beta-lactam antibiotics Drug: Phenoxymethyl Penicillin
Device: MN array
Healthy volunteers Completed 2019
35. Pain and safety of MNs in the oral cavity Other: MNs
Other: Hypodermic needle
Other: Flat patch
Oral cavity disease Completed 2019
36. MNs patch study in healthy infants/young children Device: MNs Formulation 1
Device: MNs Formulation 2
Vaccination
Skin absorption
Completed 2020