Functional Microarray Augmentation of Skin Treatment With Lidocaine

University of Oklahoma

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Pain Perception Phlebotomy

Interventions

4% lidocaine gel application with sham microneedle deviceDRUG

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

Microneedle-facilitated lidocaine applicationDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Oklahoma Schusterman Clinic

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Venipuncture pain levels

Time frame: 1 hour

Secondary Outcomes

Undesirable side effects

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.