Safety Demonstration of Microneedle Insertion
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2016
CompletedDecember 16, 2016
December 1, 2016
4 months
August 26, 2015
December 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Nickel allergic
Participants have proven nickel allergy
Interventions
The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.
Eligibility Criteria
15 subjects will be enrolled in the trial. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible to enroll in the trial.
You may qualify if:
- Proven nickel allergy
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of British Columbia
Vancouver, British Columbia, V6T 1Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Urs Hafeli, Ph.D.
Professor
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2015
First Posted
December 16, 2016
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 16, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share