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| Name | Class |
|---|---|
| Nuvo Research Inc. | INDUSTRY |
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This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synera® for 30min & Lidoderm® for 4 hours | Active Comparator | Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. |
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| Lidoderm® for 30min & Synera® for 4 hours | Active Comparator | Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated Lidocaine/Tetracaine Patch | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin. | Approximately 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds. | Approximately 5 months |
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Inclusion:
Subject is male or female 18-60 years of age, inclusive.
Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
Subject has normal, intact skin bilaterally at the antecubital area.
If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Backonja, MD | CRI Lifetree | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
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| 5% Lidocaine Patch | Drug |
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