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OpenTrials
Completed

NCT Number: NCT02995057

Safety Demonstration of Microneedle Insertion

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.

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Key information

Conditions

Allergic Reaction to Nickel Dermatitis Dermatitis, Contact Hypersensitivity Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Proven nickel allergy

Exclusion criteria

  • Pregnancy

Treatment and study plan

Gold- or silver-coated, or uncoated nickel microneedles

Device

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

Primary outcomes

  1. Skin reaction as measured by a contact dermatitis classification system

    Time frame: 7 days

    Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 16, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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