Trial Outcomes & Findings for Lidocaine Administration Using STAR Particles (NCT NCT06034340)
NCT ID: NCT06034340
Last Updated: 2024-08-20
Results Overview
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.
COMPLETED
NA
22 participants
Day 1 at 10 minutes or 20 minutes after application of LET gel
2024-08-20
Participant Flow
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.
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.
Unit of analysis: Arms
Participant milestones
| Measure |
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.
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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.
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|---|---|---|
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Overall Study
STARTED
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22 22
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22 22
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Overall Study
10 Minutes After LET Gel Application
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11 11
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11 11
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Overall Study
20 Minutes After LET Gel Application
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11 11
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11 11
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Overall Study
COMPLETED
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22 22
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22 22
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Overall Study
NOT COMPLETED
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0 0
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine Administration Using STAR Particles
Baseline characteristics by cohort
| Measure |
ALL PARTICIPANTS
n=22 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.
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|---|---|
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Age, Continuous
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13.36 years
STANDARD_DEVIATION 1.72 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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19 Participants
n=5 Participants
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Race/Ethnicity, Customized
Mixed (Black/White)
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Mixed (Pacific Islander/White)
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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22 participants
n=5 Participants
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Weight
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50.3 kilograms (kg)
STANDARD_DEVIATION 13.4 • n=5 Participants
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Height
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156.7 centimeters (cm)
STANDARD_DEVIATION 12.4 • n=5 Participants
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Body Mass Index (BMI)
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20.2 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
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Body Surface Area (BSA)
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1.47 square meters (m^2)
STANDARD_DEVIATION 0.24 • n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 at 10 minutes or 20 minutes after application of LET gelPopulation: 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).
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.
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Arms
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Arms
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.
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|---|---|---|
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Percent of Sharp (as Opposed to Dull) Sensation Over Application Area
Assessment of the area at 10 minutes post applications
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51.6 Percentage of area with sharp sensation
Standard Error 29.32
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82.0 Percentage of area with sharp sensation
Standard Error 18.6
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Percent of Sharp (as Opposed to Dull) Sensation Over Application Area
Assessment of the area at 20 minutes post applications
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55.7 Percentage of area with sharp sensation
Standard Error 21.8
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89.0 Percentage of area with sharp sensation
Standard Error 15.6
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PRIMARY outcome
Timeframe: Day 1 at 10 minutes or 20 minutes after application of LET gelPopulation: 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).
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).
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Arms
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Arms
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.
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|---|---|---|
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Application Site Pain Assessment
VAS at 10 minutes post-applications
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3.09 score on a scale
Standard Error 1.83
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4.09 score on a scale
Standard Error 1.92
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Application Site Pain Assessment
VAS at 20 minutes post-applications
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4.18 score on a scale
Standard Error 0.96
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5.32 score on a scale
Standard Error 1.47
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SECONDARY outcome
Timeframe: Day 1 at baseline and immediately after application of LET gelPopulation: All 22 participants underwent TEWL measurements before and after the STAR and aloe (Control) gel applications.
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.
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Arms
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Arms
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.
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|---|---|---|
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Change in Transepidermal Water Loss (TEWL)
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25.0 g/m^2/hr
Standard Error 8.7
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14.8 g/m^2/hr
Standard Error 4.3
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SECONDARY outcome
Timeframe: Immediately, 1 hour, 24 hours, and 7 days after application.Participants were observed for acute skin reactions at each application site on both arms.
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Participants
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Participants
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.
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|---|---|---|
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Number of Participants With Acute Skin Reactions (ASRs)
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Immediately after application, 1 hour after application and up to 1 week after applicationAll adverse events were documented starting immediately after lidocaine application up to 1 week after application.
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Participants
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Participants
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.
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|---|---|---|
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Number of Participants Experiencing Adverse Events
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Immediately after application, 1 hour after application and up to 1 week after applicationAll serious adverse events were documented starting immediately after lidocaine application up to one week after application.
Outcome measures
| Measure |
LET Gel After STAR Particle Application (Right or Left Arm)
n=22 Participants
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.
|
LET Gel Application Without STAR Particle Application (Contralateral Arm)
n=22 Participants
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.
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|---|---|---|
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Number of Participants Experiencing Serious Adverse Events
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0 Participants
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0 Participants
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Adverse Events
LET Gel After STAR Particle Application (Right or Left Arm)
LET Gel Application Without STAR Particle Application (Contralateral Arm)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eric Felner -Professor of Pediatrics
Emory University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place