Allergic Reaction to NickelNCT02995057
Safety Demonstration of Microneedle Insertion
An observational study of Allergic Reaction to Nickel, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Reaction to Nickel
- What is being tested?
- Gold- or silver-coated, or uncoated nickel microneedles
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Proven nickel allergy
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
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.
- Conditions
- Allergic Reaction to Nickel
- Being tested
- Gold- or silver-coated, or uncoated nickel microneedles
- Keywords
- Microneedles, Biocompatibility, Allergy, Metal, Nickel, Contact dermatitis
- Medical subject headings
- Hypersensitivity, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold- or silver-coated, or uncoated nickel microneedlesDevice
The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.
| Study group | Role | What they receive |
|---|---|---|
| Nickel allergic | Participants have proven nickel allergy Receives: Device: Gold- or silver-coated, or uncoated nickel microneedles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Reaction to NickelStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Urs Hafeli, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995057
- Sponsor's protocol ID
- H14-02324
- Status last verified
- Dec 2016
- First submitted
- 26 Aug 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Demonstration of Microneedle Insertion
- ClinicalTrials.gov ID
- NCT02995057
- Acronym / sponsor ID
- H14-02324
- Conditions
- Allergic Reaction to Nickel
- Keywords
- Microneedles, Biocompatibility, Allergy, Metal, Nickel, Contact dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nickel allergic | – | Device: Gold- or silver-coated, or uncoated nickel microneedlesParticipants have proven nickel allergy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Proven nickel allergy
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold- or silver-coated, or uncoated nickel microneedlesThe stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles. | Device | Nickel allergic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Allergic Reaction to Nickel
Recruiting
Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
Allergic Contact Dermatitis, Metal Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urs Hafeli, Ph.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Reaction to Nickel, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin reaction as measured by a contact dermatitis classification system (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.