Safety Demonstration of Microneedle Insertion
- Conditions
- Allergic Reaction to Nickel
- Interventions
- Device: Gold- or silver-coated, or uncoated nickel microneedles
- Registration Number
- NCT02995057
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Proven nickel allergy
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nickel allergic Gold- or silver-coated, or uncoated nickel microneedles Participants have proven nickel allergy
- Primary Outcome Measures
Name Time Method Skin reaction as measured by a contact dermatitis classification system 7 days Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada