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Safety Demonstration of Microneedle Insertion

Safety Demonstration of Microneedle Insertion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02995057
Enrollment
15
Registered
2016-12-16
Start date
2015-08-31
Completion date
2015-12-31
Last updated
2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Reaction to Nickel

Keywords

Microneedles, Biocompatibility, Allergy, Metal, Nickel, Contact dermatitis

Brief summary

Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety in patients. An alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a result, they are better received by patients and do not induce needle anxiety. As the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.

Interventions

DEVICEGold- or silver-coated, or uncoated nickel microneedles

The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Proven nickel allergy

Exclusion criteria

* Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Skin reaction as measured by a contact dermatitis classification system7 daysAllergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026