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Completed

NCT Number: NCT06034340

Lidocaine Administration 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.

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Key information

Conditions

Anesthesia, Local

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Children's Center

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: STAR Particle preparation

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.

Other names: Aloe Gel before LET Gel application, Topical Lidocaine, Control

Primary outcomes

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

    Time frame: 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.

  2. Application Site Pain Assessment

    Time frame: 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).

Secondary outcomes

  1. Change in Transepidermal Water Loss (TEWL)

    Time frame: 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.

  2. Number of Participants With Acute Skin Reactions (ASRs)

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

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

  3. Number of Participants Experiencing Adverse Events

    Time frame: 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.

  4. Number of Participants Experiencing Serious Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Children's Healthcare of Atlanta

Registry information

Official study title

Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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