Functional Microarray Augmentation of Skin Treatment With Lidocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Perception Phlebotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Group Type SHAM_COMPARATOR

4% lidocaine gel application with sham microneedle device

Intervention Type DRUG

Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).

Microneedle

Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Group Type EXPERIMENTAL

Microneedle-facilitated lidocaine application

Intervention Type DRUG

Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device

Interventions

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4% lidocaine gel application with sham microneedle device

Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).

Intervention Type DRUG

Microneedle-facilitated lidocaine application

Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device

Intervention Type DRUG

Other Intervention Names

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4% Lidocaine gel with sham-functional microarray (FMA) 4% lidocaine gel with functional microarray

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No