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NCT01145326 Clinical Trial

Functional Microarray Augmentation of Skin Treatment With Lidocaine

Pain Perception Clinical Trial

— FAST  

Official title:
Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01145326
Other study ID # OUDEM 2010-1
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received June 14, 2010
Last updated March 14, 2017
Start date January 2015
Est. completion date December 2017

Study information
Verified date March 2017
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 4% lidocaine gel application with sham microneedle device
Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
• Microneedle-facilitated lidocaine application
Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device

Locations
Country Name City State
United States University of Oklahoma Schusterman Clinic Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Venipuncture pain levels 1 hour
Secondary Undesirable side effects 1 day
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