PLIAGLIS SUMMARY
PLIAGLIS™ (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per tube.
PLIAGLIS™ is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
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NEWS HIGHLIGHTS
Published Studies Related to Pliaglis (Lidocaine / Tetracaine Topical)
Lidocaine/tetracaine peel in topical anesthesia prior to laser-assisted hair
removal: Phase-II and Phase-III study results. [2014]
peel"), which air-dries and can be peeled off 30 min post-application... CONCLUSIONS: After a 30-min application, LT peel was effective and well-tolerated
Lidocaine/tetracaine patch (Rapydan) for topical anaesthesia before arterial
access: a double-blind, randomized trial. [2012]
non-inferior to subcutaneous local anaesthetic... CONCLUSIONS: Both the lidocaine/tetracaine patch and subcutaneous injection of
Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (Synera) patches compared with placebo patches applied to healthy adult volunteers. [2010.11]
BACKGROUND: The heated lidocaine/tetracaine patch (Synera; ZARS Pharma, Inc, Salt Lake City, UT) is among the local topical anesthetic formulations used to prevent procedural pain. This study was conducted to determine the depth and duration of anesthesia provided by the patch and to evaluate safety and tolerability... CONCLUSIONS: The heated lidocaine/tetracaine patch is well tolerated, and it provides favorable depth and duration of anesthesia without significant sensory loss for superficial venous access and minor dermatological procedures after a 30-min application.
Warm lidocaine/tetracaine patch versus placebo before pediatric intravenous cannulation: a randomized controlled trial. [2008.07]
STUDY OBJECTIVE: We compare the pain of intravenous (IV) cannulation in pediatric emergency department (ED) patients after applying a topical lidocaine/tetracaine patch versus placebo. We hypothesized that application of the active patch would reduce the pain of IV cannulation by at least 15 mm... CONCLUSION: Application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in pediatric ED patients and did not alter the rate of successful cannulations.
Randomized, double-blind, placebo-controlled study evaluating the lidocaine/tetracaine patch for induction of local anesthesia prior to minor dermatologic procedures in geriatric patients. [2005.03]
BACKGROUND: Topical anesthetics offer a noninvasive method of anesthesia. OBJECTIVE: To evaluate the efficacy and safety of the lidocaine/tetracaine patch, a 1:1 (wt:wt) eutectic mixture of lidocaine and tetracaine, for local anesthesia before minor dermatologic procedures in geriatric patients... CONCLUSION: The lidocaine/tetracaine patch is a safe and effective method for noninvasive induction of local anesthesia for minor dermatologic procedures in patients over the age of 65 years.
Clinical Trials Related to Pliaglis (Lidocaine / Tetracaine Topical)
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis [Recruiting]
This project will be a double blind study comparing the efficacy of two different topical
anesthetics used to reduce the pain associated with insertion of dental needles on the
palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.
In order to complete a number of different dental procedures it is often necessary to
provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are
often uncomfortable and even painful. In an effort to increase patient comfort, a topical
anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic
treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of
the hard palate as part of the initial step in standard local anesthetic injection. At the
injection site and prior to the needle stick, the mucosa will be topically anesthetized by
using one of the two different test compounds (Benzocaine or Pliaglis). After the injection
patients will be asked to score the level of discomfort associated with the needle stick.
The purpose of the project is to determine if there is a clinical difference in the level of
pain felt upon needle stick, between the two different topical anesthetics.
Synera Venipuncture Pain [Completed]
Synera, which is a heated topical patch containing both lidocaine and tetracaine, is
intended to reduce the pain associated with venipuncture and superficial dermatologic
procedures by numbing the skin. This study will test the effectiveness of the Synera
lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia
in adult oncology patients undergoing venipuncture as part of their care, for treatment or
diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study
hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be
observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a
0-10 VAS
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections [Terminated]
Pharmacokinetic Study of Synera in Healthy Volunteers [Completed]
This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-,
and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without
heat.
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow [Completed]
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for
patients with lateral and medial epicondylitis and compare it to Naproxen sodius.
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