Anesthesia, LocalNCT06034340
Lidocaine Administration Using STAR Particles
A study testing LET Gel after STAR Particle Application (Right or Left Arm) and LET Gel Application without STAR Particle Application (Contralateral Arm) in people with Anesthesia, Local, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- LET Gel after STAR Particle Application (Right or Left Arm) and LET Gel Application without STAR Particle Application (Contralateral Arm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2023to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- LET Gel after STAR Particle Application (Right or Left Arm), LET Gel Application without STAR Particle Application (Contralateral Arm)
- Keywords
- STAR particles, Topical Lidocaine, Skin, Pediatrics, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LET Gel after STAR Particle Application (Right or Left Arm)Device
Also called STAR Particle preparation
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
Also called Aloe Gel before LET Gel application, Topical Lidocaine, Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LET Gel after STAR Particle Application (Right or Left Arm); Other: LET Gel Application without STAR Particle Application (Contralateral Arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 1 at 10 minutes or 20 minutes after application of LET gel
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after application, 1 hour after application and up to 1 week after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start19 Mar 2023
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Eric Felner, Emory University
- Investigators
- Eric I Felner, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034340
- Sponsor's protocol ID
- STUDY00002928
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2023
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40549079
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles
- ClinicalTrials.gov ID
- NCT06034340
- Acronym / sponsor ID
- STUDY00002928
- Conditions
- Anesthesia, Local
- Keywords
- STAR particles, Topical Lidocaine, Skin, Pediatrics, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- 19 Mar 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application | Experimental | Device: LET Gel after STAR Particle Application (Right or Left Arm), Other: LET Gel Application without STAR Particle Application (Contralateral Arm)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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LET Gel after STAR Particle Application (Right or Left Arm)Also: STAR Particle preparationSTAR 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. | Device | Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application |
| LET Gel Application without STAR Particle Application (Contralateral Arm)Also: Aloe Gel before LET Gel application, Topical Lidocaine, ControlTopical 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 | Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application |
Primary outcome
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.
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).
4 secondary outcomes
Change in Transepidermal Water Loss (TEWL)
Time frame: Day 1 at baseline and immediately after application of LET gel
Number of Participants With Acute Skin Reactions (ASRs)
Time frame: Immediately, 1 hour, 24 hours, and 7 days after application.
Number of Participants Experiencing Adverse Events
Time frame: Immediately after application, 1 hour after application and up to 1 week after application
Number of Participants Experiencing Serious Adverse Events
Time frame: Immediately after application, 1 hour after application and up to 1 week after application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40549079Tadros 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric I Felner, MD, MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LET Gel after STAR Particle Application (Right or Left Arm) and LET Gel Application without STAR Particle Application (Contralateral Arm) in people with Anesthesia, Local, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.