Lidocaine/tetracaine peel in topical anesthesia prior to laser-assisted hair removal: Phase-II and Phase-III study results. (April 2014)

• Record Type: Journal Article
• Authors: Alster, Tina; Garden, Jerome; Fitzpatrick, Richard; Rendon, Marta; Sarkany, Marlis; Adelglass, Jeffrey
• Is Part Of: Journal of dermatological treatment. Volume 25:Number 2(2014:Apr.)
• Page Start: 174
• Page End: 177
• Publication Date: 2014-04
• Subjects: Skin -- Diseases -- Treatment -- Periodicals; Skin Diseases -- drug therapy -- Periodicals; Skin Diseases -- therapy -- Periodicals; 616.5
• DOI: 10.3109/09546634.2012.715240
• Languages: English
• ISSNs: 0954-6634

Abstract

<abstract> <title></title> <p> <italic>Background</italic>: Patient comfort is essential during dermatologic procedures. <italic>Objectives</italic>: To evaluate anesthetic efficacy in laser-assisted hair removal of a self-occluding topical anesthetic (lidocaine 70mg/g and tetracaine 70mg/g, "LT peel"), which air-dries and can be peeled off 30 min post-application. <italic>Methods</italic>: Studies A (Phase–II) and B (Phase–III) were randomized, double-blind, placebo-controlled and paired. Applications of LT peel and placebo were concurrent: in Study A, 60 subjects were randomized to 30, 45, or 60-min groups, and in Study B, 50 subjects had 30-min applications. After drug removal, the investigator assessed for erythema, edema, and blanching. Efficacy evaluations followed the procedure: subject's pain [Visual Analog Scale (VAS), no to worst pain (0 – 100)], subject's/investigator's impression of anesthetic adequacy, and investigator's pain ratings. Adverse events (AEs) were recorded. <italic>Results</italic>: VAS scores were significantly lower (<italic>p</italic> < 0.05) for LT peel: mean scores were 26.7 for LT Peel vs. 44.3 for placebo (Study A total population, similar between application times) and 23 vs. 31.7 (Study B), respectively. For both studies, subject's/investigator's ratings favored LT peel (<italic>p</italic> < 0.05 vs. placebo). Mild skin reactions occurred more frequently for LT peel. <italic>Conclusions</italic>: After a 30-min application, LT peel was effective and well-tolerated in providing anesthesia for laser-assisted hair removal.</p> </abstract>