FAQ

FREQUENTLY ASKED

Questions

The Timeless family of products is a brand of hyaluronic acid dermal fillers, which includes Timeless Silk, Timeless 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 Timeless product is designed for a specific purpose.1

Timeless 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.

Timeless Lyft is approved 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 FDA-approved filler with the ability to provide fullness to the cheeks, as well as restore lost volume in the midface area. Lyft contains 0.3% lidocaine, which is added to reduce the discomfort during treatment.

Timeless 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). Timeless is also indicated for lip augmentation.

Timeless Refyne integrates with your skin to help smooth out the lines that run alongside the corners of your mouth (nasolabial folds and marionette lines)2 and the flexibility you need for natural-looking movement and expressions.3,4

Timeless 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)2 while letting you look more natural through a range of facial expressions.5

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

*XpresHAn Technology™ is known as Optimal Balance Technology outside the US. Timeless Refyne is known as Emervel® Classic and Restylane Defyne is known as Emervel® Deep outside the US.

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

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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.6

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

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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. Timeless Silk is designed to provide precise lip shaping and line control, resulting in silkier, smoother lips and natural-looking results.


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With full treatment, you can see lasting results for up to 18 months with Timeless;9* up to 12 months in the cheeks and up to 6 months in facial wrinkles and folds, such as nasolabial folds, with Timeless Lyft;7 6 months with Timeless Silk;11 and up to 12 months in the facial wrinkles and folds (such as nasolabial folds and marionette lines) with Timeless Refyne and Timeless Defyne.7,8

Timeless 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.11

Timeless Lyft: In a clinical trial involving 200 subjects, investigators observed that 90% of subjects treated with Timeless 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.10

Timeless: 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 Timeless 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.9

Timeless Refyne & Timeless Defyne: In a clinical study of subjects treated for laugh lines with Timeless Refyne and Timeless 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 Timeless 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 Timeless Refyne and with Timeless Defyne after 6 weeks.7,13,14

* 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.

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Depending on your volume needs, most Timeless 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, Timeless products act like your body’s own hyaluronic acid (and eventually break down naturally). Each Timeless product is designed for a specific purpose.

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

  • Number of treatment sessions needed
  • Amount of Timeless product used per session
  • Degree of necessary correction determined by you and your specialist
  • Specialist fees
  • Discounts and special offers
  • Geographic marketSince 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.

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After your treatment, you may experience side effects, such as swelling, redness, pain, bruising, headache and itching at injection site and tenderness. 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. 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 Timeless family of products.

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

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

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The Timeless 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 Timeless Silk, Timeless lyft, Timeless, Timeless Refyne or Timeless Defyne

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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 facial aesthetic treatments, including Timeless Silk, Timeless lyft, Timeless, Timeless Refyne and Timeless Defyne! Just be sure to ask your healthcare professional if his or her practice is part of the ASPIRE Galderma Rewards program.

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References:

  1. Data on file. Fort Worth, TX: Galderma Laboratories, L.P.
  2. Segura S, Anthonioz L, Fuchez F, Herbage B. A complete range of hyaluronic acid filler with distinctive physical properties specifically designed for optimal tissue adaptations. J Drugs Dermatol 2012;11(1 Suppl):s5-s8.
  3. Data on file. 05DF1502 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2016.
  4. Data on file. MA-32418 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2016.
  5. Data on file. GLI.04.SRE.US10346 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2016.
  6. Vleggaar D, Fitzgerald R. Dermatological implications of skin aging: a focus on supraperiosteal volumization for perioral rejuvenation. J Drugs Dermatol. 2008;7:209-220.
  7. Timeless Refyne. Instructions for Use. Galderma Laboratories, L.P., 2016.
  8. Timeless Defyne. Instructions for Use. Galderma Laboratories, L.P., 2016.
  9. Timeless. Instructions for Use. Galderma Laboratories, L.P., 2016.
  10. Timeless Lyft. Instructions for Use. Galderma Laboratories, L.P., 2016.
  11. Timeless Silk. Instructions for Use. Galderma Laboratories, L.P., 2016.
  12. Papakonstantinou E, Roth M, Karakiulakis G. Hyaluronic acid: A key molecule in skin aging. Dermatoendocrinol 2012;4(3):253-258.
  13. Data on file. RD.06.CIR.18156 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2013.
  14. Data on file. RD.06.CIR.18159 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2013.

Instructions for Use

Important Safety Information

The Timeless family of products includes Timeless®, Timeless-L®, Timeless® Lyft with Lidocaine, Timeless® Silk, Timeless® Refyne, and Timeless® Defyne.

APPROVED USES
Timeless® and Timeless-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Timeless® and Timeless-L® are also indicated for injection into the lips in patients over the age of 21.

Timeless® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Timeless® Lyft with Lidocaine is also indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21.

Timeless® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

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

Timeless® 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.

Are there any reasons why I should not use products within the Timeless® 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 Timeless  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
  • Timeless, Timeless-L, Timeless® Lyft with Lidocaine, Timeless Refyne and Timeless Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Timeless and Timeless-L are also intended for lip enhancement. Timeless® 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 Timeless® 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.

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

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

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.

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

© 2018 Galderma Laboratories, L.P.
All trademarks are the property of their respective owners.