SOURCE: Galderma

March 26, 2008 09:52 ET

Getting Past the Pain of Common Cosmetic Procedures

New Pliaglis™ Cream Helps Ensure More Comfortable Aesthetic Treatment Experience

FT. WORTH, TX--(Marketwire - March 26, 2008) - Demand for cosmetic procedures such as laser resurfacing, dermal filler injections and laser hair removal is at an all-time high. However, the discomfort associated with these aesthetic enhancements may give pause to those contemplating a first -- or second -- visit to the doctor's office. Now there's a new topical anesthetic -- Pliaglis™ (lidocaine and tetracaine 7%/7%) Cream, the highest concentration of active ingredients approved by the Food and Drug Administration (FDA), to reduce pain associated with cosmetic procedures. Pliaglis™ Cream is the first and only topical anesthetic that goes on as a cream and dries to an easily removed peel.

Anesthetically "Ap-peel-ing"

Pliaglis™ Cream has a unique cream-to-peel technology that does not require the skin to be wrapped in plastic like some other topical anesthetics.

Pliaglis™ Cream should remain on the skin for 20 to 30 minutes for most cosmetic procedures such as dermal filler injections and up to 60 minutes for more painful procedures. Other topical anesthetics require a minimum of 60 minutes and up to 120 minutes depending on the procedure.

Smooth, Soothe, Remove, Improve

After the peel is removed, skin is numbed and ready for the procedure.

"Sometimes the anesthetic we use can be just as important as the procedure in terms of patient satisfaction," says Dr. Macrene Alexiades-Armenakas, a dermatologic and laser surgeon in private practice in Manhattan. "Pliaglis™ Cream is a significant advancement in patient comfort combining two proven topical anesthetics to help reduce pain."

A More Pleasant Experience

The unique combination of 7 percent lidocaine and 7 percent tetracaine is the highest concentration of active topical anesthetic ingredients approved by the FDA. Research indicates that lidocaine provides rapid onset of numbing, and tetracaine may provide a lasting effect, which may help control post-procedural discomfort.

Pliaglis™ Cream is indicated for use on intact skin in adults to provide topical anesthesia for superficial cosmetic procedures.

Safety and Efficacy Supported by Extensive Study

Pliaglis™ Cream is well-tolerated with a proven safety profile, and it has been studied in 12 clinical trials with more than 2,100 patients. Typical side effects, as with most topical anesthetics, are application site redness, skin discoloration and swelling.

The basis for FDA approval included studies that assessed patient pain associated with superficial dermatologic procedures such as dermal filler injections, pulsed dye laser therapy (PDL) and facial laser resurfacing. After application times ranging between 20-60 minutes prior to the procedure, treatment with Pliaglis™ Cream resulted in statistically significantly less pain compared to placebo as measured by Visual Analogue Scale (VAS), a tool used to help subjects rate the intensity of pain.

In a 20 subject study where Pliaglis™ Cream was compared to the most widely-used topical anesthetic, eutectic mixture of local anesthetics (EMLA®), Pliaglis™ Cream showed superior anesthesia for cutaneous laser resurfacing on the face. Both Pliaglis™ Cream and EMLA® were applied to bilateral (split face) areas of the cheek for 30 minutes prior to single-pass CO2 resurfacing. The mean patient ratings using the VAS were 2.66 for Pliaglis™ Cream vs. 5.25 for EMLA®. Ninety-five percent of the patients (19/20) reported adequate pain relief with Pliaglis™ Cream versus twenty percent (4/20) with EMLA®.

About Pliaglis™ Cream

Pliaglis™ Cream has a unique cream-to-peel delivery system that helps aid in the penetration of the active ingredients as well as create an elegant transition from anesthesia to procedure. Pliaglis™ Cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, PDL, facial laser resurfacing and laser-assisted tattoo removal. Local reactions associated with Pliaglis™ Cream are generally mild and transient, have not been reported to interfere with clinical outcomes, and resolve soon after treatment.

About Galderma

Galderma is a worldwide dermatology company, marketing prescription and over-the-counter products for the treatment of skin conditions such as acne, rosacea, psoriasis, and melasma. Major brands include Differin® (adapalene .01% and .03%) Gels and Cream, Metrogel® 1% (metronidazole 1%); Cetaphil® Cleansers and Moisturizers, Clobex® shampoo, lotion and spray (clobetasol propionate 0.05%) and Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%).

Important Safety Information

The most common side effects when using Pliaglis™ Cream are local, dermal reactions like redness, skin discoloration (blanching, bruising and red spots) and swelling. Most events are mild and stop soon after treatment. Speak to your doctor if your symptoms persist several hours after treatment. Headache, dizziness, nausea, vomiting or fever may be signs of central nervous system involvement, so tell your doctor immediately if you have these symptoms. Also, if you suffer from methemoglobinemia, hepatic disease, or are pregnant or nursing, you need to tell your doctor before using Pliaglis™ Cream. Use of Pliaglis™ Cream may lead to diminished sensation on treated skin, so take care to avoid trauma to the treated areas. If you are sensitive to products containing lidocaine, tetracaine, or PABA, you should not use Pliaglis™ Cream. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Contact Information

  • Contact:
    Megan Cuozzi
    Marina Maher Communications
    212/485-6840
    Email Contact

    Contact:
    Dale Weiss
    Galderma Laboratories, L.P.
    817/961-5186
    Email Contact