Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)

January 23, 2018 updated by: Microdermics Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec City, Quebec, Canada, G1P 0A2
        • inVentiv Health Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening)
  2. Able to understand the informed consent form and willing to participate in study
  3. Intact skin at the sites of injection

  4. 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:

    1. intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
    2. male condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration;
    3. hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study;
    4. sterile male partner (vasectomized since at least 6 months).

Exclusion Criteria:

  1. Fear or anxiety of needles, or needle phobia
  2. Known sensitivity to nickel
  3. Presence of a skin condition at the treatment are that may affect the configuration or thickness of the dermal layer (e.g. plaque psoriasis)
  4. 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
  5. 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)
  6. Any implantable metal device in the treatment area
  7. 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).
  8. Any form of suspicious lesion on the treatment area
  9. Hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin.
  10. Any infection/abscess/pain in treatment area
  11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash
  12. History of skin allergy or hypersensitivity
  13. History of easy bruising
  14. Actively taking antibiotics for an infection
  15. 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.
  16. Any other condition that would exclude the subject study participation according to the Investigator's clinical judgment
  17. Concurrent participation in any other clinical study
  18. Unable to understand the informed consent
  19. Unable to verbally communicate in English or French
  20. If female, pregnant, suspected or planning to become pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm
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).
Device: Microneedle Adapter (Model UAR-2S)
Investigational device
Device: Hypodermic needle + syringe
Control device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the performance of the Microneedle Adapter in the inner forearm
Time Frame: 1 day
Consistency of injected fluid volume by gravimetric technique
1 day
Evaluate the performance of the Microneedle Adapter in the deltoid
Time Frame: 1 day
Consistency of injected fluid volume by gravimetric technique
1 day
Evaluate the performance of the Microneedle Adapter in the thigh
Time Frame: 1 day
Consistency of injected fluid volume by gravimetric technique
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate pain perception of the Microneedle Adapter vs. the control device
Time Frame: 1 day (post needle injection and post fluid injection)
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
1 day (post needle injection and post fluid injection)
Collection and evaluation of adverse events [safety and tolerability]
Time Frame: 2 weeks
Events will be reported by severity and causality
2 weeks
Assessment of contact dermatitis using Draize Scale [safety and tolerability]
Time Frame: 2 weeks
Draize scale has 4 components (Hemorrhage/petechiae, Erythema, Edema, Pruritus) with scores 0 up to 5, where 5 indicates worst event
2 weeks
Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design
Time Frame: 2 weeks
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Microdermics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Larouche, MD, inVentiv Health Clinique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UAR-CLIN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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