Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults

Phase

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT00107835

SCP-45-05

Ages > 18
All Genders

Study Summary

The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient is 18 years of age or older.
Patient elects to undergo a minor or major dermal procedure.
Patient is able to read and understand a written informed consent and has signed anddated a written informed consent.

Exclusion

Exclusion Criteria:

Patient has known allergies, contraindications or sensitivities to lidocaine,tetracaine, or other local anesthetics of the amide or ester type or to any componentsof the test materials.
Patient has known active atopic dermatitis at the designated treatment site.
Patient has damaged, denuded or broken skin at the designated treatment site.
Patient is pregnant or breastfeeding.
Patient has participated in an investigational study or clinical trial of anunapproved drug within the previous 30 days.
Patient has enrolled in any previous study involving S-Caine Peel.

Study Design

May 01, 2005

September 30, 2005

Study Description

The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.

S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.

The purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults.

Connect with a study center

International Dermatology Research Inc.
Miami, Florida 33144
United States
Site Not Available
Midwest Cutaneous Research
Clinton Township, Michigan 48038
United States
Site Not Available
Laser and Skin Surgery Center of New York
New York, New York 10016
United States
Site Not Available
Tennessee Clinical Research Center
Nashville, Tennessee 37215
United States
Site Not Available
Texas Dermatology Research Institute
Dallas, Texas 75230
United States
Site Not Available

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