Functional Microarray Augmentation of Skin Treatment With Lidocaine

Phase 2

Withdrawn

• Conditions: Pain Perception; Phlebotomy
• Interventions: Drug: Microneedle-facilitated lidocaine application; Drug: 4% lidocaine gel application with sham microneedle device

• Registration Number: NCT01145326
• Lead Sponsor: University of Oklahoma

Brief 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.

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 Timeline

• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Study Start: 2015-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-16
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedle	Microneedle-facilitated lidocaine application	Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.
Control	4% lidocaine gel application with sham microneedle device	Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Primary Outcome Measures

Name	Time	Method
Venipuncture pain levels	1 hour

Secondary Outcome Measures

Name	Time	Method
Undesirable side effects	1 day

Trial Locations

Locations (1)

University of Oklahoma Schusterman Clinic; 🇺🇸 Tulsa, Oklahoma, United States