Restylane® Defyne™

What is the Restylane family of products, and how are Restylane® Silk, Restylane® Lyft, Restylane®, Restylane® Refyne and Restylane® Defyne different?

The Restylane family of products is a brand of hyaluronic acid dermal fillers, which includes Restylane Silk, Restylane Lyft, Restylane, Restylane Refyne and Restylane Defyne. Each is a clear gel formulation of hyaluronic acid specifically formulated to act like your body's own naturally produced hyaluronic acid. Each Restylane product is designed for a specific purpose.1

Restylane Silk is the first FDA-approved product specifically designed for subtle lip augmentation and the smoothing of wrinkles around the mouth. It is composed of a gel that is smaller and smoother than other Restylane products, resulting in a softer, more precise result — ideal for restoring and enhancing the lips. Additionally, Silk is administered via ultrafine needle, which is designed for improved accuracy and precision.

Restylane Lyft is approved by the FDA to correct volume deficit in the back of the hands, for cheek augmentation and the correction of age-related midface contour deficiencies, as well as the treatment of moderate to severe facial folds, such as the nasolabial folds (smile lines). Lyft is the first and only hyaluronic filler approved by the FDA to treat face and hands.2,3 Lyft contains 0.3% lidocaine, which is added to reduce the discomfort during treatment.

Restylane is used to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds). Restylane is also indicated for lip augmentation.

Restylane Refyne integrates with your skin to help smooth out the lines that run alongside the corners of your mouth (nasolabial folds and marionette lines)4 and the flexibility you need for natural-looking movement and expressions.5,6

Restylane Defyne is designed to act like your body’s own hyaluronic acid to help smooth out deeper lines around your mouth (nasolabial folds and marionette lines)4 while letting you look more natural through a range of facial expressions.

Restylane products are approved only for patients over the age of 21.

What are dermal fillers? What is hyaluronic acid?

Dermal fillers are facial injection treatments used to help diminish wrinkles while restoring volume and fullness in the face and hands. There are several types of dermal fillers, one being hyaluronic acid. All Restylane products are transparent hyaluronic acids, which are sugars naturally found in the skin that help provide hydration, fullness and elasticity.

What causes wrinkles?

Wrinkles are part of life — our skin changes as we age. It becomes thinner, loses fat, and no longer looks as plump and smooth as it once did. Facial aging actually begins in your 20s, when skin firmness begins to decrease as a result of both internal (genetics and natural aging) and external (sun exposure, smoking, stress, etc) factors.8

WHAT HAPPENS AS WE AGE?

Hyaluronic acid is a naturally occurring substance in your skin that helps provide fullness and elasticity, with the help of collagen and elastin.
Hyaluronic acid, collagen, and elastin diminish as we age, causing skin to lose volume, while increasing the chances for wrinkles and folds to appear.
What causes the appearance of aging in hands?

As part of the natural aging process, volume in the hands can deteriorate over time, making them appear aged.9 Veins, tendons and bones may become more visible.

What are “cupid bow” lips?

The “cupid’s bow” is the double curve of the upper lip, resembling the bow of Cupid, Roman god of love. The upper lip is believed to be most attractive when it is well-defined and when the two sides look the same. Everyone’s facial structure is different, and so is everyone's ideal lip shape and size. Restylane Silk is designed to provide precise lip shaping and line control, resulting in silkier, smoother lips and natural-looking results.

How long do Restylane treatments last?

With full treatment, you can see lasting results for up to 18 months in nasolabial folds with Restylane;10 up to 12 months in the cheeks, up to 6 months in the back of the hands, and up to 6 months in facial wrinkles and folds, such as nasolabial folds, with Restylane Lyft;3 6 months for lips and perioral rhytids with Restylane Silk;11 and up to 12 months in the facial wrinkles and folds (such as nasolabial folds and marionette lines) with Restylane Refyne and Restylane Defyne.12,13

Restylane Silk: In clinical studies, the results of Restylane Silk lasted approximately 6 months following treatment. In a U.S. clinical trial involving 221 mostly female subjects, 98% of subjects reported a visible improvement in lip fullness in upper and lower lip (combined) 14 days after injection, and 77% still had lip improvement at 6 months following injection.

Restylane Lyft: In a clinical trial involving 150 subjects, blinded evaluators observed that 90% of subjects treated with Restylane Lyft showed an improvement in fullness in the right and left midface areas (combined) at 2 months, and 54% of subjects showed an improvement at 12 months. Additionally, 95% of subjects reported that they were satisfied with the appearance of their midface at 2 months, and 73% of subjects were satisfied at 12 months.3 In a clinical trial involving 89 treated subjects, blinded evaluators observed that 86% of subjects* treated with Restylane Lyft showed an improvement in volume of the back of the hands at 3 months, and 76% of subjects* showed an improvement at 6 months. Improvement was defined as subjects with a Merz Hand Grading Scale (MHGS) score of ≥1 grade from baseline by the blinded evaluator's live assessment.3

*n=85 subjects treated.

Restylane: In a clinical study treating the lines from the nose to the corners of the mouth (laugh lines), blinded evaluators reported that 95% of subjects improved for up to 18 months when they received an initial Restylane treatment, plus a follow-up treatment approximately 4.5 or 9 months later. Using this Restylane regimen of treatments, blinded evaluators reported similar subject improvement, on average, at 18 months compared to their Week 2 Wrinkle Severity Rating Scale (WSRS) score.10

Restylane Refyne & Restylane Defyne: In a clinical study of subjects treated for laugh lines with Restylane Refyne and Restylane Defyne, investigators reported improvement in the appearance of wrinkles for up to 12 months in the majority of patients. Using the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles, with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles, investigators reported that 79% of Restylane Refyne subjects and 77% of Restylane Defyne subjects had at least a 1-grade improvement on the WSRS after 6 weeks. Subjects also performed self-assessments (SSA) of wrinkle severity, with most reporting at least a 1-grade improvement in SSA scores with Restylane Refyne and with Restylane Defyne after 6 weeks.12,14,15

*The duration of effectiveness of Restylane for the correction of nasolabial folds (NLFs) was evaluated in a randomized, evaluator-blinded multicenter study. Restylane was shown to have an overall duration of effectiveness of 18 months from baseline following retreatment at 4.5 or 9 months.

How long does it take Restylane treatments to work?

Depending on your volume needs, most Restylane treatment appointments last less than an hour and begin to work almost immediately by adding volume to smooth away wrinkles. A clear gel formulation of hyaluronic acid, Restylane products act like your body's own hyaluronic acid (and eventually break down naturally). Each Restylane product is designed for a specific purpose.

How much do Restylane treatments cost?

There are several factors that figure into how much treatment will cost, including:

Number of treatment sessions needed
Amount of Restylane product used per session
Degree of necessary correction determined by you and your specialist
Specialist fees
Discounts and special offers
Geographic market
Since injection costs will vary from person to person, the best way to determine projected costs is to visit with your specialist.

Coupon or rebate programs through Galderma and/or a specialist may be available from time to time. It’s a good idea to ask your specialist if there’s a discount program available at the time of consultation. We highly recommend joining ASPIRE Galderma Rewards, our loyalty program that rewards you with special points, offers and rewards for every Galderma aesthetic treatment you receive — not just the Restylane family.

What are the side effects of Restylane products?

After your treatment, you may experience side effects, such as swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site and impaired hand function. These are typically mild in severity and normally last less than 7 days in nasolabial folds and less than 14-18 days in lips. Patients should be limited to 6.0 mL per treatment of moderate to severe facial wrinkles and folds. For treatment of volume deficit in the hands, patients should be limited to 3.0 mL per hand per treatment. Swelling may be more likely in patients under 36 years, and bruising may be more likely in patients over 35 years. Please see below for Important Safety Considerations for the Restylane family of products.

Are there any before and after pictures of Restylane results?

View our Restylane Silk, Restylane Lyft, Restylane, Restylane Refyne and Restylane Defyne galleries to see real treatment results.

How many treatments of Restylane products are needed?

Initial Restylane treatments are usually complete in one or two sessions, as needed. Depending on your individual body chemistry, you will work with your specialist to determine a maintenance schedule. Talk to your physician or healthcare professional about your individual needs. Find a specialist near you.

Can I buy Restylane products online?

You can only receive Restylane products from a trained specialist. Restylane Silk, Restylane Lyft, Restylane, Restylane Refyne and Restylane Defyne are administered by a physician or qualified healthcare professional. Find a specialist near you.

Who should not use Restylane products?

The Restylane family of products should not be used by people who:

Are pregnant, breastfeeding, or under 22 years of age
Have recently used drugs that thin the blood or prevent clotting, have had previous bad allergies, particularly to microorganisms known as gram-positive bacteria, have serious allergies to drugs that have previously required in-hospital treatment
Have bleeding disorders, have a known allergy to lidocaine, if using Restylane Silk, Restylane lyft, Restylane, Restylane Refyne or Restylane Defyne

Are rebates available on Restylane products?

Rebates and treatment discounts are at the discretion of your local healthcare professional or med spa. However, we invite you to join our loyalty program — ASPIRE Galderma Rewards — to earn rewards, bonuses and discounts for any and all Galderma aesthetic treatments for face and hands, including Restylane Silk, Restylane Lyft, Restylane, Restylane Refyne and Restylane Defyne! Just be sure to ask your healthcare professional if his or her practice is part of the ASPIRE Galderma Rewards program.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

You have severe allergies with a history of severe reactions (anaphylaxis)
You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
You are prone to bleeding or have been diagnosed with a bleeding disorder

Are there other precautions that I should discuss with my doctor?

Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Restylane® Lyft with Lidocaine is also intended for injection in the dorsal hand to correct volume loss. Treatments in other areas of the face or body have not been evaluated in clinical studies.
The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies.
Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
Tell your doctor if you are on any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
Tell your doctor if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.
Tell your doctor if you have diseases, injuries, or disabilities of the hand.

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P. at 1-855-425-8722.

The Restylane family of products is available only through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.

What are the ingredients?

Restylane® Defyne is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. The product has a sodium hyaluronate concentration of 20 mg/mL in phosphate buffered saline at pH 7 and contains 3 mg/mL lidocaine hydrochloride.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.