Clinical trial NCT00110253: Duration of Skin Numbing Effect Created by the S-Caine™ Peel
Official title: A Randomized, Double-Blind, Paired, Placebo Controlled Study Evaluating the Duration of Anesthetic Effect Produced by the S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) When Applied for 30 and 60 Minutes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 anesthetic effect.

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

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older.
* Meet pinprick test requirements.

Exclusion Criteria:

* Subject is pregnant or breastfeeding.
* Subject has participated in a clinical trial of an unapproved drug within the previous 30 days.

Primary outcomes:
measure: Duration of anesthetic effect
timeFrame: first time after onset when the number of painful pinpricks was 3 or more for 2 consecutive time points
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 72 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Radiant Research
state: California
Study officials:
affiliation: Radiant Research San Diego
name: William Garland, MD
role: PRINCIPAL_INVESTIGATOR
References: