Safety Demonstration of Microneedle Insertion

Allergic Reaction to Nickel Clinical Trial

Official title:

Safety Demonstration of Microneedle Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995057
• Other study ID #: H14-02324
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: December 13, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Proven nickel allergy

Exclusion Criteria:

• Pregnancy

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Reaction to Nickel
• Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin reaction as measured by a contact dermatitis classification system	Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.	7 days	Yes