title: Lidocaine/tetracaine peel in topical anesthesia prior to laser-assisted hair removal: Phase-II and Phase-III study results.
abstract: BACKGROUND
  Patient comfort is essential during dermatologic procedures.
  
  
  OBJECTIVE
  To evaluate anesthetic efficacy in laser-assisted hair removal of a self-occluding topical anesthetic (lidocaine 70 mg/g and tetracaine 70 mg/g, "LT peel"), which air-dries and can be peeled off 30 min post-application.
  
  
  METHODS
  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.
  
  
  RESULTS
  VAS scores were significantly lower (p < 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 (p < 0.05 vs. placebo). Mild skin reactions occurred more frequently for LT peel.
  
  
  CONCLUSIONS
  After a 30-min application, LT peel was effective and well-tolerated in providing anesthesia for laser-assisted hair removal.
authors: Washington Institute of Dermatologic Laser Surgery , Washington, DC , USA.
authors: Tina
authors: T
authors: Alster
authors: Jerome
authors: J
authors: Garden
authors: Richard
authors: R
authors: Fitzpatrick
authors: Marta
authors: M
authors: Rendon
authors: Marlis
authors: M
authors: Sarkany
authors: Jeffrey
authors: J
authors: Adelglass
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000779:Anesthetics, Local / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006204:Hair Removal / Q000379:methods*; D006801:Humans; D053685:Laser Therapy; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D013748:Tetracaine / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D004338:Drug Combinations; D013748:Tetracaine; D008012:Lidocaine