Sculptra® Aesthetic

Age doesn’t have to look the way it used to. It’s more subtle. More gradual. Shouldn’t your anti-age be just as subtle?

Introducing Sculptra® Aesthetic (injectable poly-L-lactic acid). Not an overnight miracle. Long lasting. Not a quick fix. The first facial injectable that gives you subtle results over time. Replacing lost collagen. Giving you a more natural-looking appearance, without giving you away. A full treatment of Sculptra Aesthetic, an average of 3 injection sessions over a few months, can last up to 2 years. Individual results and treatment sessions may vary. So you have more time to see how sensational subtle can be. Welcome to the new age of anti-age.

Sculptra Aesthetic is a new type of facial injectable made from poly-L-lactic acid (a synthetic material that has been used safely for decades in resorbable stitches and as an injectable since 1999 in
over 30 countries. It is biocompatible and biodegradable. Poly-L-lactic acid is the main ingredient in Sculptra Aesthetic), which helps to replace lost collagen. It helps correct shallow to deep facial wrinkles and folds that appear with aging by replacing lost collagen. Safety and effectiveness of Sculptra Aesthetic have not been evaluated in areas other than nasolabial wrinkles and folds in clinical trials.

How does Sculptra® Aesthetic work?

Sculptra Aesthetic gradually replaces lost collagen

Collagen is a key structural component that keeps skin youthful-looking and smooth. As you age, your body’s collagen production decreases, and you may begin to see wrinkles. Sculptra Aesthetic works to correct shallow to deep facial wrinkles and folds as it replaces lost collagen, which can help provide
a refined, more youthful-looking appearance. Safety and effectiveness of Sculptra Aesthetic have not been evaluated in areas other than nasolabial wrinkles and folds in clinical trials.

Sculptra Aesthetic works to replace lost collagen in a series of treatments administered by a Sculptra trained physician. On average, 3 injection sessions are needed over a period of a few months. The number of injection sessions and the number of injections per session vary from person to person.

Sculptra Aesthetic works within the deep dermis

Within the deep dermis, your skin’s structure is reinforced as Sculptra Aesthetic helps to replace lost collagen. This reinforced collagen structure provides a foundation that gradually restores the look of fullness of your shallow to deep facial wrinkles and folds that has been depleted over time. Safety and effectiveness of Sculptra Aesthetic have not been evaluated in areas other than nasolabial wrinkles and folds in clinical trials. The result? Sculptra Aesthetic is different because it gradually and subtly corrects these facial wrinkles. This can provide a refined, more youthful-looking appearance that can last up to 2 years. Individual results and treatment sessions may vary.

Side effects of Sculptra Aesthetic may include injection site discomfort, redness, bruising, bleeding, itching and swelling.

Sculptra® Aesthetic is different in the way it works

Provides gradual results that can last up to two years*

Sculptra Aesthetic is a facial injectable that works gradually in a series of treatments — on average, three injection sessions over a few months — for a subtle, more youthful looking appearance. Welcome to the new age of anti-age.

Goes to the source of facial aging

Sculptra Aesthetic targets the underlying causes of the signs of facial aging. It can give you noticeable results that emerge subtly and can last for up to two years.* It begins to work within the deep dermis, where your skin’s structure is reinforced as Sculptra Aesthetic helps to replace lost collagen. This reinforced collagen structure provides a foundation that gradually restores the look of fullness of your shallow to deep facial wrinkles and folds that have depleted over time. The result? Sculptra Aesthetic is different because it gradually and subtly corrects these facial wrinkles. This can provide a refined, more youthful looking appearance that can last up to two years.*

Is biocompatible and biodegradable

Sculptra Aesthetic is made from a synthetic material called poly-L-lactic acid, which is gradually and naturally absorbed by the body as it works to replace lost collagen. Poly-L-lactic acid has been used safely for decades in dissolvable stitches and since 1999 as a facial injectable in over 30 countries.

You should not use Sculptra Aesthetic if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring.

*Individual results and treatment sessions may vary.

Choosing the anti-aging treatment that’s right for you

It’s a good idea to know what you would like to get out of your treatment. A clear and open conversation with our office is important. We want to make sure you get all the information you need to make the decision that is right for you. So consider whether the following are important to you:

  • Gradual effects that work over time, not overnight
  • A subtle look, so it’s not obvious that work has been done
  • A treatment that replaces lost collagen
  • Proven results that can last up to two years. Individual results may vary

Being prepared can also get you the information you need to help make the right decision for you. Here are some questions about Sculptra® Aesthetic that we can answer for you:

  • How does Sculptra Aesthetic work?
  • Will it make me look like I’ve had work done?
  • Is there any other treatment that works like Sculptra Aesthetic?
  • I know that more than one treatment session may be required. How many do you think I would need?
  • How long might the treatment effects last?
  • What are the possible side effects of treatment with Sculptra Aesthetic?
  • When can I expect to see results?
  • How soon after treatment can I resume my normal activities?
  • Is there any ingredient in Sculptra Aesthetic that I may be allergic to?

Use in the skin near the eyes is not recommended.

Is Sculptra® Aesthetic Safe?

Sculptra Aesthetic is made from a synthetic material called poly-L-lactic acid, which is gradually and naturally absorbed by the body as it works to replace lost collagen. Poly-L-lactic acid has been used safely for decades in dissolvable stitches and as a facial injectable since 1999 in over 30 countries.

Side effects may include injection site discomfort, pain, redness, bruising, swelling, and/or tenderness. Small bumps under the skin and larger lumps under the skin in the treated area may also appear.
Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In a key clinical study the numbers of small and larger lumps were low and most resolved without treatment. These typically go away on their own. You should talk to your doctor if you experience any side effects or have questions after treatment.

In a clinical trial for Sculptra Aesthetic, participants most commonly reported the following side effects:

  • Redness
  • Swelling
  • Tenderness
  • Injection site pain

Some participants also reported bruising, bleeding, and/or itching at the injection site.

With each treatment session, your doctor will provide you with aftercare instructions that may help minimize side effects. Aftercare may include massaging and icing the treated area. Do not apply ice directly to the skin.

No allergy testing is required prior to treatment.

Sculptra Aesthetic should always be administered by a physician who has been specifically trained on Sculptra Aesthetic.

IMPORTANT SAFETY INFORMATION

You should not use Sculptra Aesthetic if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Sculptra Aesthetic should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.

Side effects of Sculptra Aesthetic may include injection site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In a key clinical study the numbers of small and larger lumps were low and most resolved without treatment.

INDICATION

Sculptra Aesthetic is intended for use in people with healthy immune systems as one-time treatment regimen of up to 4 injection sessions that are scheduled about 3 weeks apart for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. Sculptra Aesthetic may provide cosmetic correction of facial wrinkles with a Wrinkle Assessment Score of 2, 3, or 4 as shown in the photos in Figure 2 of the attached/accompanying full Prescribing Information.

For full Prescribing Information, please visit SculptraAesthetic.com.

A Division of Premier Dermatology, LLC