- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145326
Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST)
March 14, 2017 updated by: University of Oklahoma
Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74135
- University of Oklahoma Schusterman Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control
Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.
|
Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
Other Names:
|
Experimental: Microneedle
Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.
|
Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Venipuncture pain levels
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Undesirable side effects
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen H. Thomas, MD MPH, University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 14, 2010
First Submitted That Met QC Criteria
June 15, 2010
First Posted (Estimate)
June 16, 2010
Study Record Updates
Last Update Posted (Actual)
March 16, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- OUDEM 2010-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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