In the world of noninvasive aesthetic treatments, nothing comes close to the popularity and accessibility of facial fillers. This catch-all term encompasses the wide scope of unique gels that doctors use to accentuate bone structure, highlight our best features, and restore fullness that's lost with age. The majority of dermal fillers approved by the U.S. Food and Drug Administration (FDA) — and the most well-known among patients — are formulated with hyaluronic acid (HA), a temporary hydrating substance that occurs naturally in the body. But the classic, oft-overlooked category of biostimulatory fillers are finally getting their due, including the doctor-beloved Sculptra.
The FDA just expanded Sculptra's approved use for treating fine lines and wrinkles, a new label that allows for more treatment possibilities and a wider patient audience, meaning Sculptra's time spent in the shadow of HA-based fillers may be coming to an end.
What is Sculptra, and how does it work?
Sculptra is a biostimulatory filler — like Radiesse and Bellafill — that triggers the natural biological process of collagen production. It was initially formulated and FDA-approved in 2004 to increase collagen production for the treatment of HIV-associated lipoatrophy, or severe fat loss, in the face, says Michael Somenek, M.D., a Washington, D.C.-based board-certified facial plastic surgeon and participant in the recent FDA study trials. He says that, over time, doctors "started to notice the continued improvements with collagen stimulation and volumization to the face," leading them to explore additional applications.
Sculptra's syrupy gel formulation is made of strong polymer called poly-L-lactic acid, a substance similar to dissolvable sutures, according to Dr. Hayag, that jumpstarts the body's natural process of collagen production to reveal a longer-lasting fullness than HA-based fillers. Once Sculptra is injected, PLLA creates a biostimulatory effect within the tissues, explains Dr. Somenek, which, in turn, "improves the collagen locally, right below those wrinkles." As collagen synthesis progresses over the next six to 12 weeks, Dr. Somenek says that this extra boost will improve the skin tone while "over time, softening the appearance of those wrinkles."
New York City-based board-certified dermatologist Marie Hayag, M.D. is a self-confessed Sculptra die-hard who had been using the filler off-label for years to thicken crepey skin and smooth deep skin creases. "The best way to think of Sculptra is the process being similar to growing your lawn with seed, not sod," she says. "It's a slow, gradual effect, but it gives the best and most natural results over time."
Sculptra is widely available in dermatologist and plastic surgeons offices across the US. Prices will vary based on location, practitioner, and amount of product used, but patients can expect a range of $850 to $2,000.
How is the new FDA label different?
There are several updates in Sculptra's expanded FDA label. Most notably, the approval cements what many dermatologists and plastic surgeons have known for years: Sculptra's ability to camouflage fine lines and wrinkles. "Up until this point, we haven't been able to demonstrate its true effect on facial wrinkles," says Dr. Somenek. "We saw some really great results in terms of smile line reduction and improvement to the quality of the skin, which is something that was never really looked at previously. We knew people had a 'Sculptra glow,' but we'd just never assessed it before."
Now that Sculptra's ability to smooth fine lines and improve skin quality and texture is officially confirmed, all three doctors Allure spoke to believe this will change the world of injectables. New York City-based board-certfied dermatologist Shereene Idriss, M.D., believes the new label will "open up the conversation and make Sculptra more of a colloquial term" so that patients seeking filler are already familiar with Sculptra when they come in.
On a formula level, Sculptra's parent pharmaceutical company Galderma also tweaked the dilution among the powder, sterile water, and lidocaine blend that doctors mix together before injecting, which allows for easier, more uniform injection. "Sometimes with the more concentrated dilution, the syringe would clog because the particles would get lodged within the needle," Dr. Somenek says of the original Sculptra. "But this higher dilution makes it a lot easier to inject without compromising your results."
Another helpful update: Providers no longer have to let Sculptra dilute for days before use. "Previously, we were told to let it marinate on the shelf for a couple of days before we used it," explains Dr. Somenek of the powder and saline mixture that Sculptra is composed of, a change he says makes the process infinitely easier.
"Letting it sit on the shelves was a little nerve-wracking, because what if a patient comes in and says that they want Sculptra and you don't have any diluted?" says Dr. Somenek. "But instead, now I can say, 'Great, let me go dilute it right now.'"
What are the pros of Sculptra?
Unlike its hyaluronic acid-based relatives, Sculptra's effects become more visible over time, and it gives your body the tools to carry on its work. "Everyone loses collagen as we age, which is what causes sagginess, loose skin, and fine lines and wrinkles," says Manhattan-based board-certfied dermatologist, Bruce Katz, M.D. He explains that rather than "providing the [instant] filling action like other fillers do," Sculptra works by stimulating long-term collagen production, so the body is able to restore lost volume on its own.
By tapping our own bodies to naturally add volume to the areas where Sculptra is injected, patients are at much less risk of being overfilled. "Sometimes, patients that have been using HAs over the years start to have that doughy look," says Dr. Hayag. "You don't have that puffy or doughy look with Sculptra, [because] it gives the best and most natural results over time."
Sculptra is also considered semi-permanent because the activated collagen growth continues far beyond the average hyaluronic acid filler lifespan of six to 10 months. "Many of my patients love that they can do a series of Sculptra treatments and have results that last years, versus coming into the office every ten months for other types of fillers," says Dr. Katz.
While Dr. Hayag tends to reserve the Sculptra conversation for patients in their 40s, Dr. Somenek starts even younger as more of a preventative treatment. "We lose collagen daily around the age of 30," he says. "So I think everyone, really, starting in their thirties is some candidate for Sculptra, whether it's just one preventative vial every other year, or starting in your forties and fifties where you do a slew of treatments every four to six weeks."
What are the downsides of Sculptra?
Doctors and patients alike tend to tread lightly when it comes to Sculptra, says Dr. Somenek, for two very serious reasons: it is not reversible like HA-based fillers, which can be disintegrated with a shot of hyaluronidase, and it requires a slow and steady marathon mindset with results taking months to appear. One of the most common gripes doctors have with Sculptra is that there's no equivalent reversal enzyme, like hyaluronidase for HA fillers, in the event that nodules or bumps begin to form. So, for better or worse, you're committed to the result, at least for Sculptra's reported two-year lifespan.
"We've tried different things," says Dr. Hayag of the mostly fruitless attempts to dissolve Sculptra nodules with laser therapies or saline injections. "It can be done if it's very superficial and in areas where can be taken out surgically, but you're going to end up with scars," she says. "Often surgery isn't an option and a patient just has to wait it out."
Dr. Hayag recently treated a patient who had Sculptra placed in her temple hollows by another dermatologist, and shortly after, experienced what the medical community labels "an adverse event," with the formation of "yellowish bumps that you could see and we just couldn't get out."
For this exact reason, Dr. Idriss sticks to HA fillers for new patients before diving into Sculptra. "I'd rather them see how they respond to filler and to altering tiny elements of their face," she says. "I'd rather do it with something that I know is reversible in case they decide it’s not for them."
Thanks to our immediate gratification-seeking culture, many patients want that rush of adrenaline that comes with their doctor handing over a mirror seconds after injecting their face with filler to collectively admire their instantly plumper, curvier visage. But according to Dr. Idriss, Sculptra is all about the long game.
"The big issue with Sculptra which is not going to change is that you're going to need several treatments," says Dr. Idriss, who tells her patients that HA fillers are like dating, but Sculptra is akin to making the commitment and getting married.
"You can't liken it to a filler, it truly is a collagen stimulator," says Dr. Somenek. "I make that distinction in the office on a daily basis, because it isn't [a situation] where you're creating cheeks right away and patients walk out of the office going, 'Oh my God, I love the way I look." Instead, the gratification with Sculptra is delayed, and the results appear in slow motion, gradually, over a series of months and follow-up appointments.
"It's not just a financial investment; it's also a time investment because people have to massage their own face for a few days post-procedure to get the product fully integrated," Dr. Idriss explains, adding that the result "can also be a little bit of a toss-up because not everyone metabolizes or produces collagen the same way."
What's next for Sculptra?
Now that Sculptra is FDA-approved to plump and fill deep wrinkles, many are wondering just how far these volumizing and smoothing powers go. There are already patients requesting Sculptra for a noninvasive — and very expensive — mini BBL or hand rejuvenation, says Dr. Hayag, who adds that she doesn't use it for the latter due to the procedure's risky nature.
But the word on the medical street is that Sculptra has its eyes on clinching another expanded label for the treatment of cellulite. According to Dr. Somenek, the science here checks out, noting the skin's visible "Sculptra glow." And Dr. Hayag notes Sculptra's secondary effect of improving skin quality, tone, and texture, especially for patients with pitted acne scars, once the stimulated collagen growth ramps up. "If someone has little indented acne scars, I've seen Sculptra improve that over time," says Dr. Hayag, who adds that it improves the skin quality overall in nearly every patient she's treated.
"I think we're going to see a lot more about Sculptra," says Dr. Somenek. "I think this opened up a lot of doors for what we can use Sculptra for."