Lidocaine Administration Using STAR Particles

Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles

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 Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Device: LET Gel after STAR Particle Application (Right or Left Arm); Other: LET Gel Application without STAR Particle Application (Contralateral Arm)

Detailed Description

This study aims to find out if the combination of STAR particles with numbing gel can deliver anesthesia faster than applying the gel by itself. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for the numbing gel to work more quickly and allow the area to become numb more quickly.

After pretreatment with STAR particles (applied to the right or left arm) and aloe gel (used as a control condition in the contralateral arm) a numbing gel will be applied. A Pin-Prick test will be performed to evaluate local anesthesia from the numbing gel; half the participants will be evaluated 10 minutes after application of the numbing gel and the other half will be assessed 20 minutes after the numbing gel is applied. The study team will also assess pain after needle insertion and measure how much water is being lost from the skin using a device called a Vapometer before and after the STAR particle and aloe gel applications. Participants will have follow-up calls 24 hours and 1 week after the visit to ask about any changes to the skin where the STAR particles were applied.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application; 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); 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.; Other Names: STAR Particle preparation; Other: LET Gel Application without STAR Particle Application (Contralateral Arm); 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.; Other Names: Control; Topical Lidocaine; Aloe Gel before LET Gel application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Transepidermal Water Loss (TEWL)	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.	Day 1 at baseline and immediately after application of LET gel
Number of Participants With Acute Skin Reactions (ASRs)	Participants were observed for acute skin reactions at each application site on both arms.	Immediately, 1 hour, 24 hours, and 7 days after application.
Number of Participants Experiencing Adverse Events	All adverse events were documented starting immediately after lidocaine application up to 1 week after application.	Immediately after application, 1 hour after application and up to 1 week after application
Number of Participants Experiencing Serious Adverse Events	All serious adverse events were documented starting immediately after lidocaine application up to one week after application.	Immediately after application, 1 hour after application and up to 1 week after application

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Eric I Felner, MD, MS, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2023
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Skin; Pediatrics; Topical Lidocaine; STAR particles
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: STUDY00002928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes