At a glance

ClinicalIndex Comparison Record

N/ACompleted· 22 enrolled

Drug / intervention

LET Gel after STAR Particle Application (Right or Left Arm) +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06034340

NCT06034340N/ACompleted

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Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles

Emory University·interventional·Posted Sep 13, 2023·Updated Aug 20, 2024

In Brief

A clinical study evaluating LET Gel after STAR Particle Application (Right or Left Arm) and LET Gel Application without STAR Particle Application (Contralateral Arm) for Anesthesia, Local. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a specific area? Research participants will provide feedback on how quickly the STAR particles with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnesthesia, Local

CountriesUnited States

CollaboratorsChildren's Healthcare of Atlanta

Timeline

N/ACompletedFinished

202420252026

Enrollment StartMar 2023

Primary CompletionJun 2023

First PostedSep 2023

TodayJul 2026

First PostedSep 13, 2023

Enrollment StartMar 19, 2023

Primary CompletionJun 13, 2023

TodayJul 2, 2026

Enrollment to primary: 3 monthsPosted 2.8 years ago

Interventions

LET Gel after STAR Particle Application (Right or Left Arm)device

STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles vary in concentration and length in order to find the optimal concentration and length. Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa.

LET Gel Application without STAR Particle Application (Contralateral Arm)other

Topical lidocaine (0.5 gm of Lidocaine in LET gel) will be applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation.