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

Dharma Therapeutics

Status and phase

Completed

Phase 2

Conditions

Local Anesthesia

Treatments

Device: Iontophoretic Drug Delivery System with Epinephrine

Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00889642

Dharma-NSCO3

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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