Lidocaine Administration Using STAR Particles

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this study is to find out if the combination of STAR particles with numbing cream can deliver anesthesia faster than applying the cream 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 cream to work more quickly and allow the area to become numb more quickly. The study will work towards finding out what combination of numbing cream and STAR particles will work more quickly than the numbing cream that is already used in children. Participants will have 1 visit when they will apply the numbing gel, have a gel with STAR particles mixed in applied, and have a Pin-Prick Pain test done to evaluate the numbing gel. The study team will also use a device called a vapometer to measure how much water is being lost from the skin at the application site before and after the STAR particle application. Participants will have follow-up calls 24 hours, 1 week, and 30 days after the visit to ask them about any changes to the skin where the STAR particles were applied.

Official Title
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Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Device: LET Gel after STAR Particle Application (Right Arm)
* Other: LET Gel Application without STAR Particle Application (Left Arm)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children, adolescents, and young adults, 10 - 21 years of age. The first 2 patients will be between the ages of 18-21 years old. 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LET Gel after STAR Particle Application<br>Children, adolescents, and young adults will receive local anesthesia via different methods: STAR particles prior to lidocaine compared to topical lidocaine without the use of the STAR particles device. | Device: LET Gel after STAR Particle Application (Right Arm)<br>* 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 in order to find the optimal concentration and length. Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying a STAR particle preparation to the volar surface of the mid-forearm at two locations (right antecubital fossa and wrist). Immediately after application of the STAR particles, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine after STAR particle application (TSP) at both sites.<br>* Other names: STAR Particle preparation;Other: LET Gel Application without STAR Particle Application (Left Arm)<br>* Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying aloe gel (CONTROL) to the volar surface of the mid-forearm at two locations (right antecubital fossa and right wrist). Immediately after application of the aloe gel, the topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, the pain will be assessed by the investigator every minute using the Pin-Prick Pain test. The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia for the topical lidocaine without STAR particle application (TLET) at both sites.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve local anesthesia | The time that the subject reports no pain (complete local anesthesia) will be recorded as the time to achieve anesthesia: TSP - Time to achieve anesthesia for STAR particles compared to TLET - Time to achieve anesthesia for application of topical lidocaine (LET gel). | From STAR particles application until anesthesia is achieved up to 1 hour | 
| Application site pain assessment | The application site pain assessment will be measured by using the visual analog scale (VAS). The VAS consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | 1 hour after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the transepidermal water loss (TEWL) | The trans epidermal water loss (TEWL) will be measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel. | Baseline and immediately after application | 
| Number of participants with acute skin reactions (ASRs) post-STAR particle application | The particle application sites will be observed for acute skin reactions. | 1 hour after application up to 1 week | 
| Assessment of adverse events (AEs) | All AEs will be documented starting after lidocaine application up to 30 days. | 1 hour after application up to 30 days after application | 
| Assessment of serious adverse events (SAEs) | All SAEs will be documented starting after lidocaine application up to 30 days. | 1 hour after application up to 30 days after application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, STAR particles, Topical Lidocaine, Pediatrics, Adolescents