Comparison Study on Topical Anesthetic Agents (LMX4 and BLT) Prior to Fractional Skin Resurfacing

NCT ID: NCT01842373

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%) or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL, although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively.

The hypothesis is that there will be no clinical difference between the two topical anesthetics.

Detailed Description

Lasers can be effectively utilized for facial rejuvenation, reduction of photoinduced rhytides, and dyschromia. Topical anesthetics are used to minimize the discomfort associated with laser induced thermal pain. There are currently several formulations of topical anesthesia. However, studies comparing the products are limited especially for the new formulations that claim increased efficacy and faster onset.

LMX4 (Ferndale Laboratories, Ferndale, Michigan) is over the counter topical anesthesia. It is 4% lidocaine that has been formulated into multilamellar vesicles containing several lipid bilayers. This unique liposomal-based delivery system has been reported to deliver a greater concentration of drug. This results in a longer duration of activity and faster onset of action without requiring occlusion.4 Liposomes assist with drug penetration because the skin is lipid bilayer that can encapsulate the drug.

BLT is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine. It is commonly prescribed as topical anesthesia. All BLT products will be compounded at the University Physicians Center Pharmacy to ensure safety and uniformity. Anecdotally, some physicians claim it is the topical anesthesia of choice prior to laser surgery.

The objective of the study is to evaluate the clinical efficacy of topical anesthetic compounds prior to fractional skin resurfacing.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LMX4

3 g of LMX4 will be applied to one half of the face for 60 minutes

Group Type: EXPERIMENTAL

BLT

Intervention Type: DRUG

BLT

3 g of BLT will be applied to half of face for 60 minutes

Group Type: ACTIVE_COMPARATOR

LMX4

Intervention Type: DRUG

Interventions

LMX4

Intervention Type: DRUG

BLT

Intervention Type: DRUG

Other Intervention Names

LMX 4 (Lidocaine 4%); BLT (Benzocaine 20%, lidocaine 6%, tetracaine 4%)

Eligibility Criteria

Inclusion Criteria

• At least 28 subjects will be included in this study.
• Subjects capable of giving informed consent.
• Patients 18 years of age and older will be included in this study.
• Any patient seeking Fraxel DUAL1550/1927 (Solta Medical) treatment on the face for rhytids, photoaging, hyperpigmentation, and acne scarring at the Hershey Medical Center dermatology clinics will be asked to participate.

Exclusion Criteria

• Age <18
• Allergy to lidocaine or tetracaine
• Women who are pregnant or breast-feeding
• Patients with cardiac or respiratory disease, seizure disorders, or neuropathy
• Patients currently taking anxiolytics and opiates

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solta Medical

INDUSTRY

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Charlene Lam

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

41491

Identifier Type: -

Identifier Source: org_study_id