Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST)
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|ClinicalTrials.gov Identifier: NCT01145326|
Recruitment Status : Withdrawn (The device is undergoing further study in China, per FDA requirements.)
First Posted : June 16, 2010
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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)
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
- Venipuncture pain levels [ Time Frame: 1 hour ]
- Undesirable side effects [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145326
|United States, Oklahoma|
|University of Oklahoma Schusterman Clinic|
|Tulsa, Oklahoma, United States, 74135|
|Principal Investigator:||Stephen H. Thomas, MD MPH||University of Oklahoma|