S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Non-Ablative Facial Laser Resurfacing in Adults
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 topical cream 7%/7%) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ZARS Pharma Inc.
Summary
Lasers are used for non-ablative resurfacing of facial rhytides, atrophic scars, and a
variety of epidermal and dermal lesions. Pain associated with the non-ablative laser
treatment has been described as moderate to severe. For this reason, local anesthesia is
commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine
7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study
is to evaluate if S-Caine Peel is effective in providing topical local dermal anesthesia for
non-ablative facial laser resurfacing in adults.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Providing Local Dermal Anesthesia for Non-Ablative Facial Laser Resurfacing in Adults
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the efficacy of S-Caine Peel in providing local dermal anesthesia for non-ablative facial laser resurfacing in adults
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:
- Patient is 18 years of age or older
- Patient elects to undergo non-ablative facial laser resurfacing procedure
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
Locations and Contacts
Midwest Cutaneous Research, Clinton Township, Michigan 48038, United States
Laser and Skin Surgery Center of New York, New York, New York 10016, United States
New York Dermatology, New York, New York 10021, United States
Additional Information
Last updated: September 27, 2005
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