Pain Clinical Trial
Official title:
A Double-Blind, Randomized, Split-Face Comparison Trial on Topical Anesthetic Agents Prior to Fractional Skin Resurfacing
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.
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.
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