Activate the skin’s natural regenerative process with Sculptra to help replenish lost facial collagen. Collagen is the most common protein in the body and helps support the skin’s inner structure.

This FDA-approved injectable subtly and gradually helps restore facial volume.

How Does Sculptra Work?

SLOW AND STEADY STRENGTH

Sculptra is made with biocompatible, biodegradable, synthetic material called poly-L-lactic acid, which is gradually and naturally absorbed by the body and helps to rebuild lost collagen through a series of treatments administered by a trained specialist.

Ashley Aesthetics injects treatment into the appropriate dermal plane where strands of collagen support your skin’s structure. Over time, Sculptra helps the body reproduce lost collagen. The number of injection appointments and the number of injections per appointment vary from person to person, depending on how much collagen has been lost. On average, three injection appointments are needed over a period of a few months.

Some commonly asked questions are answered below. Click on a question to reveal more information.

SCULPTRA is a sterile, injectable, biocompatible, biodegradable material that is made of very small particles of a synthetic polymer named “poly-L-lactic acid” (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). While the time needed for SCULPTRA to resorb in humans is not known, in rabbits, particles were visible at over one year after injection.

Sculptra is used to correct shallow to deep wrinkles and folds on the face. Administered with the appropriate injection technique from a trained specialist, Sculptra is clinically approved for:

  • Deep folds between the nose and mouth (nasolabial folds), also called “smile lines”
  • Lines framing the mouth (marionette lines)
  • Chin wrinkles

SCULPTRA is intended for use in people with healthy immune systems. SCULPTRA is injected in or under the facial skin through a small needle for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles. A treatment regimen of SCULPTRA consists of up to 4 injection sessions scheduled 3-4 weeks apart.

You should not get SCULPTRA if you:

  • Have severe allergies with a history of severe reactions (anaphylaxis) or multiple severe allergies. Use of SCULPTRA may result in an allergic reaction.
  • Are allergic to any ingredient of SCULPTRA: “poly-L-lactic acid” (PLLA), carboxymethylcellulose (USP) or non-pyrogenic mannitol (USP).
  • Previously had or have risks factors for hypertrophic scarring or keloid formation.

Collagen production in the body decreases as you get older and/or are exposed to the sun. Wrinkles are one of the first visible signs of this. SCULPTRA is injected into the deep layer of the skin where collagen naturally exists and is made. SCULPTRA works by initially filling a wrinkle with small PLLA beads. As the beads biodegrade the body may produce new collagen where SCULPTRA is injected. SCULPTRA is injected with multiple small injections using a fine needle in a grid pattern to correct a wrinkle at the nasolabial fold or other facial wrinkles where this injection technique is appropriate.

No skin testing is required prior to use in immunocompetent people with skin that heals normally.

No. Unlike other wrinkle fillers, SCULPTRA provides a gradual improvement of the depressed area over several weeks as the treatment effects occur. During the initial treatment session with SCULPTRA, a contour defect should be under-corrected, not fully-corrected or over-corrected. It may seem that your treatment worked immediately because of swelling caused by injection and the water used to dilute SCULPTRA. This usually resolves in several hours to a few days and may cause the original wrinkle to reappear: you may look as you did before your treatment. Visible wrinkle correction results appear slowly. Your healthcare provider should see you again in three or more weeks to decide if you need additional injections.

Ashley Aesthetics should see you at approximately three-four weeks after each treatment session to assess whether you need additional treatment. You may need one to four treatment sessions (typically three) to achieve the optimal correction possible. The safety and effectiveness of SCULPTRA has only been studied in a single treatment regimen of up to four sessions at three- four week intervals.

In a U.S. clinical study treatment results for some subjects lasted for up to 25 months after the last treatment session. However, the improvement depended on the severity of the nasolabial fold wrinkle (WAS score) that a subject had before treatment. Discuss with your health care provider the optimal cosmetic correction you may expect.

As with any injection, to decrease pain during injection, a topical or a local anesthetic may be used when injecting SCULPTRA. In U.S. clinical study, subjects recorded pain in diaries: 71% of all treated patients reported some pain after first injection, 14% of subjects had moderate pain. Most pain resolved in less than 24 hours.

Your healthcare provider will answer all of your questions and ask about your medical history to determine if SCULPTRA injection is appropriate for you. Tell your healthcare provider about all the medicines you are taking, even over the counter medicines or treatments. You and your healthcare provider will determine if a topical or local anesthetic is needed.

  • To prepare for an injection session, all make-up should be removed.
  • An injection grid will be decided for each facial wrinkle that is candidate for this treatment and the area to be injected will be cleaned with an antiseptic.
  • SCULPTRA will be injected in multiple small amounts into or under the skin using a fine needle in grid pattern.
  • After injection, the treated area should be massaged to distribute the product evenly.
  • An ice pack should be applied to the treatment area to help reduce swelling unless otherwise directed by your healthcare provider.

As with any injectable wrinkle filler, you can expect injection-related side effects, such as bleeding, tenderness or pain/discomfort, redness, bruising, or swelling. These side effects generally resolve within a few hours to a few days but could last for 14 days or longer. For more information on adverse events, see adverse events section.

Most patients are able to get back to their activities immediately following treatment.

Make-up may be applied a few hours after treatment if there are no complications such as open wounds or bleeding.

Sculptra is FDA approved in the United States and has been used worldwide since 1999. Sculptra is made of a synthetic material called poly-L-lactic acid that is absorbed naturally by the body and has been used for years in dissolvable stitches.

Since Sculptra does not contain any human or animal components, no allergy testing is needed prior to treatments.

Side effects reported include injection site pain, redness, bruising, tenderness, itching and lumps, bleeding or swelling. Small bumps under the skin can sometimes be noticeable when pressing on the treated area. Larger lumps, with or without inflammation, have also been reported.

The types and duration of side effects may vary. If you are experiencing side effects, talk to your Ashley Aesthetics clinician.

Specialists who have been trained to inject Sculptra and are licensed to practice may administer treatment. This can include physician assistants, nurse practitioners, registered nurses and other trained personnel.

Important Safety Information:

Indication: Sculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.

Sculptra should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.

Sculptra has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.

Sculptra should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.

The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. 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.

Sculptra is available only through a licensed practitioner. View the complete Instructions for Use.

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