S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a new skin numbing cream made of
lidocaine and tetracaine. The purpose of this study is to evaluate and measure the length
of time the S-Caine Peel numbs the skin, when applied for 30 and 60 minutes.
This was a single center, randomized, double-blind, placebo controlled, paired study that
evaluated the duration of anesthetic effect produced by S-Caine Peel when applied for 30 or
60 minutes in 40 adult volunteers. A pinprick test was used to determine duration of
At the procedure visit, subjects were to be assigned the lowest available sequential subject
number. Treatment was randomized according to a computer-generated randomization schedule
provided by the sponsor. The randomization to application time of 30 or 60 minutes was to
be 1:1 and un-blinded. The randomization of study drug to treatment area (concurrent
applications of either S Caine Peel applied to the anterior surface of the right thigh with
placebo applied to the anterior surface of the left thigh, or placebo applied to the
anterior surface of the right thigh and S-Caine Peel applied to the anterior surface of the
left thigh) was 1:1 and double-blind. Instructions for implementing the randomization (ie,
the correct application time and treatment area) appeared on the study drug labels assigned
to each subject number.
Subjects were administered both S-Caine Peel and placebo on separate thighs for either 30 or
60 minutes. The study drugs were applied concurrently to the anterior surfaces of the right
and left thigh (one application per thigh, with study drug applied to the right thigh first,
followed immediately by application of the alternate study drug to the left thigh). Each
study drug was dispensed to cover a 200 cm² treatment area with a uniform thickness of
approximately 1 mm
- Subject is 18 years of age or older.
- Meet pinprick test requirements.
- Subject is pregnant or breastfeeding.
- Subject has participated in a clinical trial of an unapproved drug within the
previous 30 days.