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. CONCLUSION: 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.

Hair removal using a combination radio-frequency and intense pulsed light source.

BACKGROUND AND OBJECTIVE: The long-term removal of unwanted hair is achieved by many laser and intense pulse light sources. One limitation is the treatment of individuals with dark skin. The light energy with the current systems has to penetrate through the epidermis before being absorbed by the hair follicle. In individuals with dark skin the high melanin concentration in the epidermis absorbs high energies that can lead to complications. The objective of our study was to study a new system that combines optical energy, intense pulsed light (IPL), with radio frequency (RF). This allows for the use of less optical energy due to the addition of RF energy. The lower optical fluence allows for safer treatment of darker skin types. STUDY DESIGN/MATERIALS AND METHODS: This was a multicenter study, in which 87 patients were enrolled. A single treatment was performed on a specified body site. Twenty-one of the 69 subjects that completed the study had skin types IV-VI. Each subject was evaluated at 1, 7, 30, and 90 days after the treatment session. RESULTS: Hair counts were significantly reduced from baseline after one treatment by an average of 46%. Individual patient data showed that the percentage in hair count reduction achieved ranged from 0 to 100%, with 43% of the patients having a 50% or greater decrease. CONCLUSIONS: The combination of optical energy and RF when delivered simultaneously achieves effective hair reduction with the use of less optical energy, allowing for the safe treatment of all skin types.