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Sponsored by: |
ZARS Pharma Inc. |
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Information provided by: | ZARS Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00110760 |
Injection of dermal filler is used as an aesthetic treatment to fill in unwanted wrinkles and scars. There can be substantial pain associated with dermal filler injections. For this reason, local anesthesia is often used to eliminate or minimize the pain. This anesthesia can be administered by injection or through the use of topical creams and ointments.
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 dermal filler injections in adults.
Condition | Intervention | Phase |
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Pain |
Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream), When Applied for 30 Minutes, for Induction of Local Dermal Anesthesia for Dermal Filler Injection on the Face of Adults |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
AboutSkin Dermatology | |
Englewood, Colorado, United States, 80113 | |
United States, Tennessee | |
Tennessee Clinical Research Center | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
J&S Studies, Inc. | |
Bryan, Texas, United States, 77802 |
Study ID Numbers: | SCP-40-05 |
Study First Received: | May 12, 2005 |
Last Updated: | September 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00110760 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tetracaine Facies Lidocaine Central Nervous System Depressants Anesthetics |
Pain Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Anesthetics, Local |
Physiological Effects of Drugs Lidocaine Anesthetics Central Nervous System Depressants Cardiovascular Agents Anesthetics, Local Pharmacologic Actions |
Tetracaine Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents |