Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Heated Lidocaine/Tetracaine Patch
- Conditions
- Healthy
- Sponsor
- CRI Lifetree
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Synera® for 30min & Lidoderm® for 4 hours
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.
Intervention: Heated Lidocaine/Tetracaine Patch
Synera® for 30min & Lidoderm® for 4 hours
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.
Intervention: 5% Lidocaine Patch
Lidoderm® for 30min & Synera® for 4 hours
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.
Intervention: Heated Lidocaine/Tetracaine Patch
Lidoderm® for 30min & Synera® for 4 hours
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.
Intervention: 5% Lidocaine Patch
Outcomes
Primary Outcomes
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
Time Frame: Approximately 5 months
Secondary Outcomes
- Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.(Approximately 5 months)