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| Sponsored by: |
ZARS Pharma Inc. |
| Information provided by: | ZARS Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00110773 |
Purpose
Pulsed dye laser (PDL) on the face is painful. 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 the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.
| Condition | Intervention | Phase |
|
Pain |
Drug: S-Caine™ Peel (lidocaine and tetracaine topical cream 7%/7%) |
Phase III |
| MedlinePlus related topics: | Anesthesia |
| ChemIDplus related topics: | Tetracaine Viractin Lidocaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Study Evaluating the Efficacy of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) to Provide Local Dermal Anesthesia for Pulsed Dye Laser Therapy in Adults |
| Estimated Enrollment: | 80 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |||||
| Washington Institute of Dermatologic Laser Surgery | |||||
| Washington, District of Columbia, United States, 20037 | |||||
| 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 | |||||
| ZARS Pharma Inc. |
More Information
| Study ID Numbers: | SCP-42-05 |
| First Received: | May 12, 2005 |
| Last Updated: | September 30, 2005 |
| ClinicalTrials.gov Identifier: | NCT00110773 |
| Health Authority: | United States: Food and Drug Administration |
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