Lidocaine Administration Using STAR Particles

NCT06034340 | Completed Results FDA Device

• 1 other identifier: STUDY00002928
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

STAR particles; Topical Lidocaine; Skin; Pediatrics; Adolescents

Outcome Measures

Primary Outcomes (2)

• Percent of Sharp (as Opposed to Dull) Sensation Over Application Area

  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.

  Day 1 at 10 minutes or 20 minutes after application of LET gel

• Application Site Pain Assessment

  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).

  Day 1 at 10 minutes or 20 minutes after application of LET gel

Secondary Outcomes (4)

• Change in Transepidermal Water Loss (TEWL)

  Day 1 at baseline and immediately after application of LET gel

• Number of Participants With Acute Skin Reactions (ASRs)

  Immediately, 1 hour, 24 hours, and 7 days after application.

• Number of Participants Experiencing Adverse Events

  Immediately after application, 1 hour after application and up to 1 week after application

• Number of Participants Experiencing Serious Adverse Events

  Immediately after application, 1 hour after application and up to 1 week after application

Study Arms (1)

Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application

EXPERIMENTAL

Children, adolescents, and young adults will receive local anesthesia with lidocaine-epinephrine-tetracaine (LET) gel via different methods on different arms. One arm will have STAR particles used prior to LET gel and the other arm will have aloe gel applied prior to LET gel.

Device: LET Gel after STAR Particle Application (Right or Left Arm); Other: LET Gel Application without STAR Particle Application (Contralateral Arm)

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.

Also known as: STAR Particle preparation

Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application

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.

Also known as: Aloe Gel before LET Gel application, Topical Lidocaine, Control

Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children, adolescents, and young adults, 10 to 21 years of age
• In good general health as determined by a medical history
• Willing to provide informed assent with parental consent and follow study requirements

You may not qualify if:

• Is chronically using pain medication
• Has a plan to move to another location in the next 12 months or foresees any other reason that participation in the study would be disrupted during the next 12 months
• Has skin disorders or skin allergies
• Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium Dioxide)
• Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application
• Has known neurological conditions that might affect sensory function or perception of pain
• Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Tadros AR, Prausnitz MR, Felner EI. Rapid local anesthesia in children enhanced by STAR particles: a first-in-humans, randomized clinical trial. Drug Deliv Transl Res. 2026 Feb;16(2):539-548. doi: 10.1007/s13346-025-01899-5. Epub 2025 Jun 23.

  PMID: 40549079 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Eric Felner -Professor of Pediatrics
• Organization: Emory University

efelner@emory.edu

404-785-0935

Study Officials

• Eric I Felner, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: March 19, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)