A Phase 3 interventional study of S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) in Pain, sponsored by ZARS Pharma Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.
Sponsored by ZARS Pharma Inc. · Phase 3, Interventional, and Treatment
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.
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.
ZARS Pharma Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.
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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
Also known as: Pliaglis
Number of participants with adverse events
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
Time frame: 20-30 minutes
Adequacy of Anesthesia
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).
Time frame: 20-30 minutes
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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ZARS Pharma Inc.