Not provided
Not provided
Not provided
Not provided
The device is undergoing further study in China, per FDA requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.
The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement. |
|
| Microneedle | Experimental | Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% lidocaine gel application with sham microneedle device | Drug | Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venipuncture pain levels | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Undesirable side effects | 1 day |
Not provided
Inclusion Criteria: age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested
Exclusion Criteria: cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen H. Thomas, MD MPH | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Schusterman Clinic | Tulsa | Oklahoma | 74135 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Microneedle-facilitated lidocaine application | Drug | Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device |
|
|