Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.

Official Title
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A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesia for Venipuncture in Healthy Adult Volunteer Subjects

Conditions
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Local Anesthesia

Intervention / Treatment
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* Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine
* Device: Iontophoretic Drug Delivery System with Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects may be of any race, either sex, and must be >18 years of age Healthy subjects as per medical screening Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study Subjects must have signed and dated a written informed consent Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment Exclusion Criteria: Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema Subjects with an open skin lesion at the treatment site Subjects who are pregnant or breastfeeding Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials Subjects who participated in previous DTI/Transcu clinical studies related to this product Subjects with known concurrent illness Subjects with current known/admitted substance abuse (alcohol/drug) Subjects with pacemakers and/or externally mounted electronic devices Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Contains Lidocaine and Epinephrine | Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine<br>* Active- 10.5% Lidocaine/0.179% Epinephrine<br>|
| Placebo Comparator: Placebo<br>Contains Epinephrine | Device: Iontophoretic Drug Delivery System with Epinephrine<br>* Placebo- 0.179% Epinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS). |  | 4 hours | 
| Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment. |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the duration of anesthesia through standard pin prick testing. |  | 4 hours |