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Safety Demonstration of Microneedle Insertion

NCT ID: NCT02995057

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Reaction to Nickel

Keywords

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Microneedles Biocompatibility Allergy Metal Nickel Contact dermatitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Nickel allergic

Participants have proven nickel allergy

Gold- or silver-coated, or uncoated nickel microneedles

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Proven nickel allergy

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urs Hafeli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H14-02324

Identifier Type: -

Identifier Source: org_study_id