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

NCT01688518 | Completed Phase 1 DMC

• 1 other identifier: LCR-07-01-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Evaluation; Depth and Duration; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.

  Approximately 5 months

Secondary Outcomes (1)

• Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.

  Approximately 5 months

Study Arms (2)

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.

Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch

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.

Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch

Interventions

Heated Lidocaine/Tetracaine Patch DRUG

Also known as: Synera® Patch

Lidoderm® for 30min & Synera® for 4 hours; Synera® for 30min & Lidoderm® for 4 hours

5% Lidocaine Patch DRUG

Also known as: Lidoderm® Patch

Lidoderm® for 30min & Synera® for 4 hours; Synera® for 30min & Lidoderm® for 4 hours

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
• A vasectomized partner,
• Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
• Intrauterine device (IUD), or
• Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
• 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.

You may not qualify if:

• Subject has clinically significant ECG abnormalities at screening.
• Subject is currently receiving class I, II, or III anti-arrhythmic agents.
• Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
• Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
• Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
• Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
• Subject has active dermatological disease of any origin that may interfere with the ability to participate.
• Subject has denuded or broken skin on either forearm.
• Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.

Sponsors & Collaborators

• CRI Lifetree: lead
• Nuvo Research Inc.: collaborator

Study Sites (1)

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Study Officials

• Miroslav Backonja, MD

  CRI Lifetree

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

US (1)