MedTrace Logo

Safety Demonstration of Microneedle Insertion

NCT02995057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2016-12-16

No results posted yet for this study

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.

Conditions

  • Allergic Reaction to Nickel

Interventions

DEVICE

Gold- 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 & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Urs Hafeli, Ph.D. · Professor

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995057 on ClinicalTrials.gov