Evaluation of the S-Caine Peel for induction of local anesthesia for laser-assisted tattoo removal: randomized, double-blind, placebo-controlled, multicenter study.
BACKGROUND
Topical anesthetics are important tools for many dermatologic procedures. The S-Caine Peel is composed of a 1:1 (w:w) eutectic mixture composed of lidocaine base 7%, USP, and tetracaine base 7%, USP. It is applied as a cream, dries on exposure to air, and forms a flexible membrane, which can be easily peeled off.


OBJECTIVE
To evaluate the effectiveness of the S-Caine Peel in providing clinically useful local dermal anesthesia for laser-assisted tattoo removal and to monitor the nature and frequency of adverse events associated with the safety of the S-Caine Peel.


METHODS
Thirty adult patients undergoing laser-assisted tattoo removal were enrolled in this multicentered, randomized, double-blind, placebo-controlled study. Each subject received both the S-Caine Peel and placebo simultaneously for 60 minutes. The primary efficacy parameter was a 100 mm visual analog scale (VAS) for patient self-assessment of pain. Secondary efficacy parameters included both the investigator's and an independent observer's evaluation of subject pain (4-point categorical scale: no pain through severe pain) and the patient's and the investigator's overall impression of the local anesthetic.


RESULTS
Mean VAS scores were 42 mm for the S-Caine Peel and 66 mm for placebo treatment sites (p=.001). Patients received adequate pain relief in 50% of S-Caine Peel sites versus 7% of placebo sites (p=.002). The percentage of those who would like to use the S-Caine Peel again were 43% for the S-Caine Peel compared with 7% for placebo (p=.005). Investigators' evaluations revealed that 70% of patients had less pain at S-Caine Peel treatment sites compared with 10% with less pain at placebo sites (p<.001), and 70% of the S-Caine Peel-treated sites achieved adequate anesthesia versus 10% of placebo sites (p<.001). The independent witness assessed less pain in 67% of S-Caine Peel-treated sites versus 10% of the placebo sites (p=.002). One occurrence of moderate to severe erythema was noted at both an S-Caine Peel and a placebo treatment site on removal of the S-Caine Peel after 60 minutes, which self-resolved quickly. There was no statistical difference between the two groups. Other side effects were limited to local mild, transient erythema at the application sites.


CONCLUSIONS
Administration of the S-Caine Peel for 60 minutes prior to laser-assisted tattoo removal was effective in significantly reducing pain levels associated with the procedure.
Chen
John Z S
JZ
Division of Dermatology, University of Louisville, Louisville, Kentucky, USA. zs_chen@hotmail.com
Jacobson
Laurie G
LG
Bakus
Aboneal D
AD
Garden
Jerome M
JM
Yaghmai
Dina
D
Bernstein
Leonard J
LJ
Geronemus
Roy G
RG
D000287:Administration, Topical; D000328:Adult; D000779:Anesthetics, Local; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D053685:Laser Therapy; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D010146:Pain / Q000517:prevention & control; D013653:Tattooing; D013748:Tetracaine / Q000008:administration & dosage*
D000779:Anesthetics, Local; D004338:Drug Combinations; C493081:S-Caine Peel; D013748:Tetracaine; D008012:Lidocaine