Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser

Summary

This is a study aimed at evaluating the efficacy of a topical anesthesia (test product) compared to placebo in adult patients of phototypes I to III, with indication of treatment of CO2 fractional laser in the forehead. In addition to efficacy, safety and tolerability of the product have been studied. The product under investigation is a topical formulation containing lidocaine 25 mg/g and prilocaine 25mg/g which in previous studies performed in the same institution with healthy subjects in adulthood showed faster onset than other formulations. In these previous studies, the product was well tolerated, and there were no signs of a skin reaction or adverse events of a systemic nature. The CO2 fractional laser treatment is routinely used by plastic surgery and dermatology for treatment with aesthetic purposes of skin imperfections. It's a procedure until certain painful point, which as a rule is performed without prior use of topical anesthetic. The test product is believed to produce a clinically significant reduction of pain when compared to placebo, during the application of CO2 laser on the forehead for the aesthetic treatment of the face.

Timeline

Start

2014-06-07

Primary completion

2014-07-25

Completion

2014-07-25

Drugs

Indications

No indication recorded.