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