Duration of Skin Numbing Effect Created by the S-Caine⢠Peel
Information source: ZARS Pharma Inc.
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
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. Official(s) and/or principal investigator(s):
William Garland, MD, Principal Investigator, Affiliation: Radiant Research San Diego
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the duration of anesthetic effect produced by S-Caine Peel when applied for 30 and 60 minutes
Secondary outcome: To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Radiant Research, San Diego, California 92123, United States
Additional Information
Starting date: June 2005
Last updated: September 21, 2005
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