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Sponsored by: |
ZARS Pharma Inc. |
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Information provided by: | ZARS Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00110747 |
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.
Condition | Intervention | Phase |
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Pain |
Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
New York Dermatology | |
New York, New York, United States, 10021 |
Study ID Numbers: | SCP-41-05 |
Study First Received: | May 12, 2005 |
Last Updated: | September 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00110747 |
Health Authority: | United States: Food and Drug Administration |
Tetracaine Facies Lidocaine Pain |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |