Intradermal InjectionNCT03415373
Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
A study testing Microneedle Adapter (Model UAR-2S) and Hypodermic needle + syringe in people with Intradermal Injection, run by Microdermics Inc. at 1 site in Canada.
Trial summary
Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR-2S) is a single-use disposable medical device intended to provide a mechanism for intradermal bolus fluid delivery when used with… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intradermal Injection
- What is being tested?
- Microneedle Adapter (Model UAR-2S) and Hypodermic needle + syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 15 Nov 2017
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening)
- Able to understand the informed consent form and willing to participate in study
- Intact skin at the sites of injection
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
- intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
- male condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration;
- hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study;
- sterile male partner (vasectomized since at least 6 months).
Who cannot join
- Fear or anxiety of needles, or needle phobia
- Known sensitivity to nickel
- Presence of a skin condition at the treatment are that may affect the configuration or thickness of the dermal layer (e.g. plaque psoriasis)
- Permanent makeup/tattoo/body piercing or other markings in the treatment area that would impact the ability to assess adverse events (e.g. erythema) following ID administration
- Use of medication that may affect the mechanical properties of the skin in the treatment area (e.g. prolonged use of a steroids, analgesics or other non-steroidal inflammatory drugs)
- Any implantable metal device in the treatment area
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- Any surgical procedure, or other invasive or non-invasive method of skin therapy hair removal or filers or Botox in the treatment area, performed in the past 1 months (in the treatment area).
- Any form of suspicious lesion on the treatment area
- Hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Any infection/abscess/pain in treatment area
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash
- History of skin allergy or hypersensitivity
- History of easy bruising
- Actively taking antibiotics for an infection
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- Any other condition that would exclude the subject study participation according to the Investigator's clinical judgment
- Concurrent participation in any other clinical study
- Unable to understand the informed consent
- Unable to verbally communicate in English or French
- If female, pregnant, suspected or planning to become pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR-2S) is a single-use disposable medical device intended to provide a mechanism for intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle integrated within the microneedle adapter with fluidic connections to a standard Luer syringe mount. The primary function of the Microneedle Adapter is to guide the microneedle into the skin in a controlled manner for successful insertion passing the stratum corneum layer. The fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The primary objective of this study is to evaluate the performance of the Microneedle Adapter in healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter will be a key secondary outcome, compared with the control device.
- Conditions
- Intradermal Injection
- Being tested
- Microneedle Adapter (Model UAR-2S), Hypodermic needle + syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle Adapter (Model UAR-2S)Device
Investigational device
Hypodermic needle + syringeDevice
Control device
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Each subject will undergo ID administration by Microneedle Adapter (Model UAR-2S) and hypodermic needle + syringe of 100 μL injectable saline into 3 different regions: the inner forearm, the deltoid and the thigh, at three (3) study visits. A total of 4 injections (2 x 50 μL saline and 2 x 100 μL saline) will be administered to each study participant in the injection sites (2 injections per inner forearm/deltoid/thigh and 2 injection per device). Receives: Device: Microneedle Adapter (Model UAR-2S); Device: Hypodermic needle + syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of the Microneedle Adapter in the inner forearm
Consistency of injected fluid volume by gravimetric technique
Measured: 1 day
Evaluate the performance of the Microneedle Adapter in the deltoid
Consistency of injected fluid volume by gravimetric technique
Measured: 1 day
Evaluate the performance of the Microneedle Adapter in the thigh
Consistency of injected fluid volume by gravimetric technique
Measured: 1 day
Secondary outcomes (4)
Evaluate pain perception of the Microneedle Adapter vs. the control device
Assessment of pain intensity using Numeric Rating Scale (NRS), a verbal 0-10 point scale where 0 means no pain and 10 means worst possible pain
Measured: 1 day (post needle injection and post fluid injection)
Collection and evaluation of adverse events [safety and tolerability]
Events will be reported by severity and causality
Measured: 2 weeks
Assessment of contact dermatitis using Draize Scale [safety and tolerability]
Draize scale has 4 components (Hemorrhage/petechiae, Erythema, Edema, Pruritus) with scores 0 up to 5, where 5 indicates worst event
Measured: 2 weeks
Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design
Assessment of end-user usability using the modified System Usability Scale (mSUS), a 10-question scale producing a normalized score 0 to 100, where 0 indicates high user dissatisfaction and 100 indicates high user satisfaction
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Nov 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradermal InjectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be first randomized to receive each of the injection (A, B, C, and D) in each of the 3 visits of the study, according to the block randomization scheme produced by inVentiv. The following sequences will be used: 1st (upper right location), 2nd (lower right location), 3rd (upper left location) and 4th lower left location) where: A. Investigational device with 50 μL saline B. Control device with 50 μL saline C. Investigational device with 100 μL saline D. Control device with 100 μL saline
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microdermics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Larouche, MD, Principal investigator, inVentiv Health Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415373
- Sponsor's protocol ID
- UAR-CLIN-001
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
- ClinicalTrials.gov ID
- NCT03415373
- Acronym / sponsor ID
- UAR-CLIN-001
- Conditions
- Intradermal Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Microdermics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR-2S) is a single-use disposable medical device intended to provide a mechanism for intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle integrated within the microneedle adapter with fluidic connections to a standard Luer syringe mount. The primary function of the Microneedle Adapter is to guide the microneedle into the skin in a controlled manner for successful insertion passing the stratum corneum layer. The fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The primary objective of this study is to evaluate the performance of the Microneedle Adapter in healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter will be a key secondary outcome, compared with the control device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be first randomized to receive each of the injection (A, B, C, and D) in each of the 3 visits of the study, according to the block randomization scheme produced by inVentiv. The following sequences will be used: 1st (upper right location), 2nd (lower right location), 3rd (upper left location) and 4th lower left location) where: A. Investigational device with 50 μL saline B. Control device with 50 μL saline C. Investigational device with 100 μL saline D. Control device with 100 μL saline
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Microneedle Adapter (Model UAR-2S), Device: Hypodermic needle + syringeEach subject will undergo ID administration by Microneedle Adapter (Model UAR-2S) and hypodermic needle + syringe of 100 μL injectable saline into 3 different regions: the inner forearm, the deltoid and the thigh, at three (3) study visits. A total of 4 injections (2 x 50 μL saline and 2 x 100 μL saline) will be administered to each study participant in the injection sites (2 injections per inner forearm/deltoid/thigh and 2 injection per device). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening)
- Able to understand the informed consent form and willing to participate in study
- Intact skin at the sites of injection
- Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
Key exclusion criteria (20 listed)
- Fear or anxiety of needles, or needle phobia
- Known sensitivity to nickel
- Presence of a skin condition at the treatment are that may affect the configuration or thickness of the dermal layer (e.g. plaque psoriasis)
- Permanent makeup/tattoo/body piercing or other markings in the treatment area that would impact the ability to assess adverse events (e.g. erythema) following ID administration
- Use of medication that may affect the mechanical properties of the skin in the treatment area (e.g. prolonged use of a steroids, analgesics or other non-steroidal inflammatory drugs)
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 |
|---|---|---|
| Microneedle Adapter (Model UAR-2S)Investigational device | Device | Intervention arm |
| Hypodermic needle + syringeControl device | Device | Intervention arm |
Primary outcome
Evaluate the performance of the Microneedle Adapter in the inner forearm
Time frame: 1 day
Consistency of injected fluid volume by gravimetric technique
Evaluate the performance of the Microneedle Adapter in the deltoid
Time frame: 1 day
Consistency of injected fluid volume by gravimetric technique
Evaluate the performance of the Microneedle Adapter in the thigh
Time frame: 1 day
Consistency of injected fluid volume by gravimetric technique
4 secondary outcomes
Evaluate pain perception of the Microneedle Adapter vs. the control device
Time frame: 1 day (post needle injection and post fluid injection)
Collection and evaluation of adverse events [safety and tolerability]
Time frame: 2 weeks
Assessment of contact dermatitis using Draize Scale [safety and tolerability]
Time frame: 2 weeks
Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design
Time frame: 2 weeks
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 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Richard Larouche, MD principal investigator
inVentiv Health Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle Adapter (Model UAR-2S) and Hypodermic needle + syringe in people with Intradermal Injection, run by Microdermics Inc. 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 8 inclusion and 20 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 30 Jan 2018. 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?
Evaluate the performance of the Microneedle Adapter in the inner forearm (time frame: 1 day). The study lists 3 primary outcomes in all. 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 30 Jan 2018.