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Sponsored by: |
ZARS Pharma Inc. |
Information provided by: | ZARS Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00107835 |
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.
Condition | Intervention | Phase |
Pain |
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
Phase III |
MedlinePlus related topics: | Anesthesia |
ChemIDplus related topics: | Tetracaine Viractin Lidocaine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Adult Patients Undergoing a Minor or Major Dermal Procedure |
Estimated Enrollment: | 370 |
Study Start Date: | April 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
International Dermatology Research Inc. | |||||
Miami, Florida, United States, 33144 | |||||
United States, Michigan | |||||
Midwest Cutaneous Research | |||||
Clinton Township, Michigan, United States, 48038 | |||||
United States, New York | |||||
Laser and Skin Surgery Center of New York | |||||
New York, New York, United States, 10016 | |||||
United States, Tennessee | |||||
Tennessee Clinical Research Center | |||||
Nashville, Tennessee, United States, 37215 | |||||
United States, Texas | |||||
Texas Dermatology Research Institute | |||||
Dallas, Texas, United States, 75230 |
ZARS Pharma Inc. |
Pain 
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Study ID Numbers: | SCP-45-05 |
First Received: | April 8, 2005 |
Last Updated: | September 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00107835 |
Health Authority: | United States: Food and Drug Administration |
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