Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST)

This study has suspended participant recruitment.
(The device is undergoing further study in China, per FDA requirements.)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01145326
First received: June 14, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.


Condition Intervention Phase
Pain Perception
Phlebotomy
Drug: 4% lidocaine gel application with sham microneedle device
Drug: Microneedle-facilitated lidocaine application
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Venipuncture pain levels [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Undesirable side effects [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.
Drug: 4% lidocaine gel application with sham microneedle device
Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
Other Name: 4% Lidocaine gel with sham-functional microarray (FMA)
Experimental: Microneedle
Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.
Drug: Microneedle-facilitated lidocaine application
Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device
Other Name: 4% lidocaine gel with functional microarray

Detailed Description:

The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested

Exclusion Criteria: cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145326

Locations
United States, Oklahoma
University of Oklahoma Schusterman Clinic
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Stephen H. Thomas, MD MPH University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01145326     History of Changes
Other Study ID Numbers: OUDEM 2010-1
Study First Received: June 14, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
venipuncture
phlebotomy
pain perception

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014