N/A
N=44
Lidocaine Administration Using STAR Particles
Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT06034340 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Percent of Sharp (as Opposed to Dull) Sensation Over Application Area — 51.6; 82.0; 55.7; 89.0 Percentage of area with sharp sensation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LET Gel after STAR Particle Application (Right or Left Arm) (Device); LET Gel Application without STAR Particle Application (Contralateral Arm) (Other)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Sharp (as Opposed to Dull) Sensation Over Application Area |
51.6; 82.0; 55.7; 89.0 | — |
| PRIMARY Application Site Pain Assessment |
3.09; 4.09; 4.18; 5.32 | — |
| SECONDARY Change in Transepidermal Water Loss (TEWL) |
25.0; 14.8 | — |
| SECONDARY Number of Participants With Acute Skin Reactions (ASRs) |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events |
0; 0 | — |
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 with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06034340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.