NCT06034340

Lidocaine Administration Using STAR Particles

Completed NA Results posted Last updated 20 August 2024

What this trial tests

NA trial testing LET Gel after STAR Particle Application (Right or Left Arm) in Anesthesia, Local in 22 participants. Completed in 13 June 2023.

Timeline

19 March 2023

Primary endpoint
13 June 2023

13 June 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	19 March 2023
Primary completion	13 June 2023
Estimated completion	13 June 2023
Sites	1 location across United States

Drugs / interventions tested

• LET Gel after STAR Particle Application (Right or Left Arm)
• LET Gel Application without STAR Particle Application (Contralateral Arm)

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →

Sponsor

Emory University

Who can join

Adults 10 to 21, any sex, with Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Sharp (as Opposed to Dull) Sensation Over Application Area Primary · Day 1 at 10 minutes or 20 minutes after application of LET gel

The time to achieve anesthesia is assessed as the percent of sharp (as opposed to dull) sensation reported at 10 or 20 minutes after the application of LET gel.

Assessment of the area at 10 minutes post applications

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	51.6	± 29.32
LET Gel Application Without STAR Particle Application (Contralateral Arm)	82.0	± 18.6

Assessment of the area at 20 minutes post applications

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	55.7	± 21.8
LET Gel Application Without STAR Particle Application (Contralateral Arm)	89.0	± 15.6

Application Site Pain Assessment Primary · Day 1 at 10 minutes or 20 minutes after application of LET gel

The application site pain assessment was measured by using the visual analog scale (VAS). The VAS consists of a 10 centimeter (cm) line with opposite endpoints representing "no pain" (coded as 0) and "pain as bad as it could possibly be" (coded as 10).

VAS at 10 minutes post-applications

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	3.09	± 1.83
LET Gel Application Without STAR Particle Application (Contralateral Arm)	4.09	± 1.92

VAS at 20 minutes post-applications

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	4.18	± 0.96
LET Gel Application Without STAR Particle Application (Contralateral Arm)	5.32	± 1.47

Change in Transepidermal Water Loss (TEWL) Secondary · Day 1 at baseline and immediately after application of LET gel

The transepidermal water loss (TEWL) was measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel.

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	25.0	± 8.7
LET Gel Application Without STAR Particle Application (Contralateral Arm)	14.8	± 4.3

Number of Participants With Acute Skin Reactions (ASRs) Secondary · Immediately, 1 hour, 24 hours, and 7 days after application.

Participants were observed for acute skin reactions at each application site on both arms.

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	0
LET Gel Application Without STAR Particle Application (Contralateral Arm)	0

Number of Participants Experiencing Adverse Events Secondary · Immediately after application, 1 hour after application and up to 1 week after application

All adverse events were documented starting immediately after lidocaine application up to 1 week after application.

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	0
LET Gel Application Without STAR Particle Application (Contralateral Arm)	0

Number of Participants Experiencing Serious Adverse Events Secondary · Immediately after application, 1 hour after application and up to 1 week after application

All serious adverse events were documented starting immediately after lidocaine application up to one week after application.

Group	Value	95% CI
LET Gel After STAR Particle Application (Right or Left Arm)	0
LET Gel Application Without STAR Particle Application (Contralateral Arm)	0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148
2. Rapid local anesthesia in children enhanced by STAR particles: a first-in-humans, randomized clinical trial.
   Tadros AR, Prausnitz MR, Felner EI. · · 2026 · PMID 40549079 · DOI 10.1007/s13346-025-01899-5