S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults

Condition(s) targeted: Pain

Intervention: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ZARS Pharma Inc.

There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.

Official title: A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Primary outcome: To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults

Secondary outcome: To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Patient is 18 years of age or older Patient elects to undergo laser-assisted tattoo removal Exclusion Criteria: Patient is pregnant or breastfeeding Patient has participated in a clinical trial of an unapproved drug within the previous 30 days Patient has participated in any previous clinical trial involving S-Caine Peel

Laser and Skin Surgery Center of New York, New York, New York 10016, United States

Ending date: September 2005
Last updated: September 21, 2005