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

Completed · Phase 2 · Has a placebo group

Conditions studied: Local Anesthesia

In brief

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.

Key facts

Study ID

NCT00889642

Run by

Dharma Therapeutics Inc.

People needed

90

Starts

2009-05-01

Expected to finish

2009-06-01

Last updated by the study team

2009-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• Vince & Associates Clinical Research — Overland Park, Missouri, United States

Full record on ClinicalTrials.gov

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