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

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889642
• Other study ID #: Dharma-NSCO3
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2009
• Last updated: June 22, 2009
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Dharma Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Device:
• Iontophoretic Drug Delivery System with Lidocaine/Epinephrine
Active- 10.5% Lidocaine/0.179% Epinephrine
• Iontophoretic Drug Delivery System with Epinephrine
Placebo- 0.179% Epinephrine

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Vince & Associates Clinical Research	Overland Park	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Dharma Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment.		4 hours
Secondary	Determining the duration of anesthesia through standard pin prick testing.		4 hours