Evaluation of the Efficacy and Safety of a Lidocaine and Tetracaine (7%/7%) Cream for Induction of Local Dermal Anesthesia for Facial Soft Tissue Augmentation with Hyaluronic Acid

Injection of dermal fillers for soft tissue augmentation is a minimally invasive cosmetic procedure with growing popularity. However, patients often express concern about pain with such procedures. A topical anesthetic cream formulated with lidocaine/tetracaine 7%7% was approved by the United States Food and Drug Administration in 2006 and recently reintroduced to the market for use during superficial dermatological procedures. A Phase 3 study was conducted to assess the efficacy and safety of lidocaine/tetracaine 7%7% cream versus placebo cream when used to induce local dermal anesthesia during injections with hyaluronic acid. Mean visual analog scale scores significantly favored lidocaine/tetracaine 7%7% cream. A significant percent of subjects also indicated that lidocaine/tetracaine 7%7% cream provided adequate pain relief and that they would use lidocaine/tetracaine 7%7% cream again. Investigators also rated lidocaine/tetracaine 7%7% cream significantly better than placebo cream for providing adequate pain relief and on the assessment of pain scale. Lidocaine/tetracaine 7%7% cream was safe and well tolerated with most subjects reporting no erythema, edema, or blanching. No related adverse events were reported with lidocaine/tetracaine 7%7% cream; one related adverse event of erythema was reported with placebo cream. The results of this study indicate that lidocaine/tetracaine 7%7% cream is efficacious and safe at providing pain relief for soft tissue augmentation with hyaluronic acid.Soft tissue augmentation with dermal fillers is a popular, minimally invasive cosmetic procedure with an increasing number of procedures performed each year.1 Despite the popularity of dermal filler procedures and other cosmetic procedures, most patients are concerned about the pain associated with these procedures.2 Seventy-four percent of surveyed subjects expressed concern about associated pain with cosmetic procedures, and 42 percent of subjects who had a cosmetic procedure would consider not having other procedures due to concerns about pain.2 These results suggest that a sizeable number of subjects are given inadequate measures to control pain during cosmetic procedures.Various types of topical anesthetics are available to manage pain and provide relief during cosmetic procedures and contain ingredients such as lidocaine, tetracaine, and prilocaine.3 Many physicians use compounded formulations of anesthetics to provide dermal anesthesia before a procedure. However, these products have been found to not be standardized and frequently have higher concentrations of anesthetics than United States Food and Drug Administration (FDA)-approved products.3 This resulted in the FDA issuing a warning in 2006 to multiple pharmacies to stop compounding topical anesthetic creams.4 And in 2007, a public health advisory was issued by the FDA when two women died after using compounded high-concentration topical anesthetics under occlusion before a procedure.5 Therefore, it is recommended that only FDA-approved topical anesthetics be used as they have demonstrated efficacy as well as safety.5An anesthetic cream formulated with lidocaine and tetracaine 7%/7% (LT cream; Pliaglis® Cream; Galderma Laboratories, LP) was approved by the FDA in 2006 and recently reintroduced to the market. LT cream is indicated for use on intact skin in adults to provide topical analgesia for superficial dermatological procedures.6 In addition to being formulated with the maximum allowable FDA-approved concentrations of lidocaine and tetracaine, LT cream also dries to a flexible membrane that functions as a self-occlusive barrier. Multiple studies have demonstrated the efficacy and safety of LT cream in various dermatological cosmetic procedures including ablative and nonablative laser resurfacing, laser tattoo removal, laser hair removal, and CO₂ laser resurfacing.7-10A Phase 3 study was conducted to investigate the efficacy and safety of LT cream when used as a topical anesthetic for facial soft tissue augmentation with hyaluronic acid. The results of this study indicate that LT cream provided significantly better pain relief than vehicle cream, was well tolerated, and is an ideal choice to provide topical anesthesia before dermal filler injections.