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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric I Felner, MD, MS | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40549079 | Derived | 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. |
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All participants received local anesthesia with LET gel via different methods on different arms. One arm had STAR particles applied before LET gel and the other had aloe gel (the control condition) applied before LET gel. Assessments for sharp sensation and pain took place at 10 minutes for half (11) of the participants and at 20 minutes for the other half (11) of the participants.
Participants were recruited from Children's Healthcare of Atlanta (CHOA) at Egleston in Atlanta, Georgia, USA. Participant enrollment began March 19, 2023, and all follow-up assessments were complete by June 13, 2023.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants received local anesthesia with LET gel via different methods on different arms. One arm had STAR particles applied before LET gel and the opposite one had aloe gel (the control condition) applied before LET gel.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALL PARTICIPANTS | All participants received local anesthesia with LETgel via different methods on different arms. One arm had STAR particles applied before LET gel and the contralateral had aloe gel (the control condition) applied before LET gel. Half of the participants (after both applications) were evaluated for sharp sensation and site pain at 10 or 20 minutes after applying the LET gel. STAR particles are made of titanium dioxide, a widely used and safe ceramic material found in sunscreens, cosmetics, and paint. The particles will vary in concentration and length to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) was applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa. For the control condition, topical lidocaine (0.5grams of Lidocaine in LET gel) was applied immediately after applying aloe gel to the volar surface of the antecubital fossa of the contralateral arm to the one receiving the STAR particle preparation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All 22 participants had STARS applied before the LET gel on either arm and Aloe (Control) gel was applied before the LET gel on the opposite arm. Half of the participants were assessed for sharp sensation at 10 minutes and the other half were evaluated 20 minutes after the application of LET gel in both participants' arms (STAR particle and aloe (Control) gel pretreatment). | Posted | Mean | Standard Error | Percentage of area with sharp sensation | Day 1 at 10 minutes or 20 minutes after application of LET gel | Arms | Arms |
|
Information on adverse events, Serious Adverse Effects, and Skin changes were assessed in both arms on the day of application, 24 hours, and 7 days after completion of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LET Gel After STAR Particle Application (Right or Left Arm) | Topical lidocaine (0.5 grams of Lidocaine in LET gel) was applied immediately after applying a STAR particle preparation to the volar surface of the antecubital fossa. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Felner -Professor of Pediatrics | Emory University | 404-785-0935 | efelner@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2023 | Jun 24, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
|
| 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. |
|
|
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body Surface Area (BSA) | Mean | Standard Deviation | square meters (m^2) |
|
| OG001 | LET Gel Application Without STAR Particle Application (Contralateral Arm) | Topical lidocaine (0.5 grams of Lidocaine in LET gel) was applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa. |
|
|
| Primary | 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). | All 22 participants had STARS applied before the LET gel on either arm and Aloe (Control) gel was applied before the LET gel on the opposite arm. Half of the participants were assessed for sharp sensation at 10 minutes and the other half were evaluated 20 minutes after the application of LET gel in both participants' arms (STAR particle and aloe (Control) gel pretreatment). | Posted | Mean | Standard Error | score on a scale | Day 1 at 10 minutes or 20 minutes after application of LET gel | Arms | Arms |
|
|
|
| Secondary | 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. | All 22 participants underwent TEWL measurements before and after the STAR and aloe (Control) gel applications. | Posted | Mean | Standard Error | g/m^2/hr | Day 1 at baseline and immediately after application of LET gel | Arms | Arms |
|
|
|
| Secondary | Number of Participants With Acute Skin Reactions (ASRs) | Participants were observed for acute skin reactions at each application site on both arms. | Posted | Count of Participants | Participants | Immediately, 1 hour, 24 hours, and 7 days after application. |
|
|
|
| Secondary | Number of Participants Experiencing Adverse Events | All adverse events were documented starting immediately after lidocaine application up to 1 week after application. | Posted | Count of Participants | Participants | Immediately after application, 1 hour after application and up to 1 week after application |
|
|
|
| Secondary | Number of Participants Experiencing Serious Adverse Events | All serious adverse events were documented starting immediately after lidocaine application up to one week after application. | Posted | Count of Participants | Participants | Immediately after application, 1 hour after application and up to 1 week after application |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | LET Gel Application Without STAR Particle Application (Contralateral Arm) | Topical lidocaine (0.5 grams of Lidocaine in LET gel) was applied immediately after applying aloe gel (control condition) to the volar surface of the antecubital fossa. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Aniline Compounds |
| D000588 | Amines |
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| VAS at 20 minutes post-applications |
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