Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults
Tracking Information | |||||
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First Received Date ICMJE | April 8, 2005 | ||||
Last Updated Date | June 4, 2012 | ||||
Start Date ICMJE | May 2005 | ||||
Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: 20-30 minutes ] [ Designated as safety issue: Yes ] To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults |
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Original Primary Outcome Measures ICMJE |
To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults | ||||
Change History | Complete list of historical versions of study NCT00107835 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Adequacy of Anesthesia [ Time Frame: 20-30 minutes ] [ Designated as safety issue: No ] To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure. The adequacy of anesthesia was evaluated by asking patients whether the study drug provided adequate pain relief for the procedure (yes or no), and by asking the investigator whether the study drug provided adequate anesthesia for the procedure (yes or no). |
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Original Secondary Outcome Measures ICMJE |
To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Detailed 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Pain | ||||
Intervention ICMJE | Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures
Other Name: Pliaglis |
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Study Arm (s) | Experimental: S-Caine Peel
Intervention: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 408 | ||||
Completion Date | September 2005 | ||||
Primary Completion Date | September 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00107835 | ||||
Other Study ID Numbers ICMJE | SCP-45-05 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | ZARS Pharma Inc. | ||||
Study Sponsor ICMJE | ZARS Pharma Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | ZARS Pharma Inc. | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |