Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST)
This study is not yet open for participant recruitment.
Verified March 2012 by University of Oklahoma
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01145326
First received: June 14, 2010
Last updated: March 27, 2012
Last verified: March 2012
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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: | May 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145326
Contacts
| Contact: Annette Arthur, BS | 918-660-3458 | Annette-Arthur@OUHSC.edu |
| Contact: Stephen Thomas, MD MPH | 918-660-3458 | Stephen-Thomas@OUHSC.edu |
Locations
| United States, Oklahoma | |
| University of Oklahoma Schusterman Clinic | Not yet recruiting |
| Tulsa, Oklahoma, United States, 74135 | |
| Principal Investigator: Stephen H Thomas, MD MPH | |
| Sub-Investigator: Annette O Arthur, BS | |
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: | March 27, 2012 |
| 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 |
ClinicalTrials.gov processed this record on May 23, 2013