A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia

A Controlled Comparative Pilot Study to Assess the Safety and Efficacy of the MicronJet Microneedle Device Following Intradermal Injection of Lidocaine for Local Anesthesia

The purpose of this study is to determine whether the MicronJet microneedle device is effective for inducing rapid and painless local anesthesia prior to insertions of intravenous catheters.

Study Overview

• Status: Completed
• Conditions: Local Anesthesia; Intradermal Injections
• Intervention / Treatment: Device: MicronJet

Detailed Description

Local anesthesia is routinely administered to reduce patient discomfort and improve the outcome of a wide variety of painful medical procedures. However, injection of a local anesthetic agent into the skin using a regular needle is in itself painful. Therefore, common procedures involving needle pricks (e.g. venipuncture) which may be quite painful are usually performed without local anesthesia.

NanoPass has developed a microneedle injection device (MicronJet) which enables painless delivery of drugs directly into the superficial layers of the skin.

The objective of the study is to assess the safety and efficacy of this device for intradermal injection of a local anesthetic agent before insertion of an intravenous catheter to healthy adults.

Each subject will receive an injection of a local anesthetic to one arm, and a control placebo injection of physiological water to the other arm. Both injections will be administered intradermally using the MicronJet. Following the injections, an intravenous catheter will be inserted into the injection site in each arm, and the subject will rate the pain caused by the insertion. Safety parameters will be recorded throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females. a signed informed consent.
• No significant abnormalities in screening physical exam.
• No significant abnormalities in clinical laboratory parameters.
• No significant abnormalities in ECG within 21 days of the start of the study.
• Intact skin at the sites of injection.
• Accessible veins in the antecubital area.

Exclusion Criteria:

• Hypersensitivity to local anaesthetics.
• History of previous vasovagal events.
• Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions at the injection sites.
• Subjects with active or chronic skin disease or systemic disease with significant skin involvement.
• History of skin allergy or hypersensitivity.
• History of easy bruising.
• Current or previous history of neurological disorders (particularly neuropathies).
• A history of drug or alcohol abuse.
• Acute infection within 7 days prior to study day.
• Subjects who participated in a clinical study within 4 weeks prior to study day, or who plan to participate in another clinical trial during the time of the trial.
• Subjects suffering from Behçet's disease.
• Pregnant or lactating women.
• Any contraindication (relative or absolute) to study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Intradermal injection of Lidocaine followed by a painful stimulus (venipuncture)	Device: MicronJet; The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.
Placebo Comparator: 2; Intradermal injection of placebo followed by a painful stimulus (venipuncture)	Device: MicronJet; The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence and intensity of adverse events	3 Days
Pain scores reported by the subjects following the painful stimulus	one minute after injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires	2 days after injection

Collaborators and Investigators

• Sponsor: NanoPass Technologies Ltd
• Investigators: Principal Investigator: Jacob Atsmon, MD, Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (Estimate): October 3, 2007

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: microneedle; intradermal; microneedles
• Other Study ID Numbers: NP40