Is It Safe To Use Qwo, The New FDA-Approved Cellulite Treatment?

What if you could get rid of cellulite in a few months, with no lifestyle changes and no invasive procedures? That’s the promise of Qwo, the first and only injectable treatment for cellulite approved by the Food and Drug Administration.

Qwo was approved in July 2020 and was first offered around the country at dermatologists’ offices and medi-spas in late spring 2021. It aims to reduce the appearance of cellulite in three rounds of injections, each 21 days apart. And while the medication itself isn’t new, this usage of it is. (It was previously used to treat a hand condition that we’ll talk about below.)

While some doctors feel it’s a safe, noninvasive treatment option, others are waiting to see its long-term effects before jumping on board.

How Qwo Works

Cellulite, dimpled-looking skin where fat accumulates on the body, affects 90% of women and 10% of men, according to Scientific American. Cellulite isn’t caused so much by the fat itself, but by the tension between muscle tissue and skin that squeezes the fat to the surface.

“Our skin is attached to the underlying muscles by tight fibrous bands, and in between the bands is fat,” said Kristen Rezak, a board-certified plastic surgeon at Duke Health. “Over time, the skin can loosen up or we gain fat, and that causes dimpling areas because these tight bands don’t stretch, and that’s what causes cellulite. It usually is targeted in areas like the butt and outside of the thighs.”

The main ingredients in Qwo are two forms of collagenase, an enzyme derived from bacteria that breaks down collagen, the main component of those fibrous bands. Once those bands are broken, the dimples will release and the skin will look smooth again. Collagenase (under the name Xiaflex) has been used in medicine for years to treat Dupuytren’s contracture, a condition that affects the hands and bends your fingers inward.

“Dupuytren’s is caused by these fibrous bands that cause the tip of the finger to bend toward the palm,” said Peter W. Henderson, assistant professor of plastic surgery and a breast reconstructive surgeon at Mount Sinai Health System. “The substance is something that’s well-known and is currently being used in other initiatives; they’ve just identified another use for it, one with a bigger market. The material is well-known and known to be safe.”

“In both the Phase II and Phase III trials, around 60% of patients found they had any degree of improvement. So, it’s statistically significant but not a complete home run.”

– Abigail Waldman, Brigham and Women’s Hospital

Despite collagenase’s good track record, Qwo still had to undergo all the phases of FDA approval for the treatment of cellulite. While it proved somewhat effective in trials, some doctors say the change wasn’t dramatic.

“They did Phase III studies that enrolled over 800 women, and it showed an all right effect,” said Abigail Waldman, a clinical director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital in Boston.

“The outcome was measured in whether patients were slightly happier or much happier, basically. In both the Phase II and Phase III trials, around 60% of patients found they had any degree of improvement. So, it’s statistically significant but not a complete home run.”

While Qwo’s website doesn’t specify how long results are expected to last, a number of medi-spas offering the treatment claim they should last a minimum of one year.

Anaya Aesthetics, based in Pasadena, California, states, “To-date, we have data to support longevity for a few years and will continue to monitor how many years patients can expect to see the substantial improvement.” DC Derm Docs’ website says, “The FDA- approved treatment for moderate to severe cellulite may last permanently. You can expect your Qwo results at least one year, but most likely, much longer.”

Is Qwo more effective than other cellulite treatments?

Liposuction and CoolSculpting can reduce fat, but they don’t specifically target cellulite. Other more invasive procedures use cutting techniques to sever the connective bands. Lasers, radiofrequency, retinol creams and more all claim to minimize cellulite’s appearance. But how does Qwo compare?

“It’s attractive because it’s an easy, minimally invasive treatment option for those who don’t want a more invasive procedure,” said Teo Soleymani, a clinical health sciences instructor and dermatologic surgeon at UCLA Health. “There is relatively minimal downtime compared to other modalities. But, as a result, the outcomes may not be as pronounced or you may not be able to treat as large of an area.”

See below for an example of a before-and-after photo that Qwo promotes, and you’ll see the difference isn’t dramatic:

Henderson cited recent studies on Qwo’s results that make it seem promising, but said that since the researchers were affiliated with the treatment, he’d like to see more unbiased evidence of its effectiveness over time.

“None of these things have been shown to be very effective,” Henderson said. “We don’t have a great clinical solution for cellulite so far, so the fact we have seen [Qwo] work in other parts of the body makes this an intriguing possibility.”

There’s serious bruising involved with Qwo.

Qwo’s website lists its possible side effects, which include injection site bruising, pain, redness, swelling and allergic reactions. A quick Google search will reveal before and after photos with bruises covering a large area, not just at the injection sites. Should that be concerning?

“Collagen also composes the lining of blood vessel walls, so we’re starting to see bruising can be extensive with Qwo partly because it can sometimes break down the very tiny blood vessels in the skin or subcutaneous tissue. It’s not harmful, but it’s visually bothersome,” Soleymani said.

Henderson agreed, saying that while the fibrous bands responsible for cellulite aren’t the only things made of collagen in that area of the body, they have the highest concentration, making them Qwo’s main target. However, Rezak explained that a small percentage of people who experience severe bruising may never heal.

“The downside is, when you have that much extensive bruising, almost always it usually just goes away but it can take weeks to a month to look like skin again. A small percentage of people can have hemosiderin staining, which stains the skin dark. That’s not been associated with Qwo, but is possible with extensive bruising,” she said.

Is Qwo safe? What are the long-term effects?

Rezak and Waldman both questioned the lack of diversity in Qwo’s Phase III trial: all of its participants were women and the majority were white, so it’s “hard to know if it can be applied to a more diverse population,” Waldman said.

Qwo has not been available long enough to know much about its long-term effects, but some physicians wonder if the body will treat it similarly to Botox.

“In the studies, almost everyone developed antibodies to the collagenase, which makes sense because it’s a foreign bacteria enzyme,” Waldman said. “I don’t know what the implications for that are. For other bacterial-derived injections, like Botox, that means in the future it doesn’t work for you. I don’t know if the same theory applies here, where if you got Qwo again in the future maybe it wouldn’t work.”

And while the bruising may subside, doctors don’t yet understand if there are long-term consequences of collagenase breaking down collagen in the blood vessels or skin around the injection area.

“We don’t really know what the long-term implications of that are, which is probably what makes me the most hesitant about this,” Waldman said. “Since it hasn’t been FDA-approved for long, we don’t know what long-term ramifications are to breaking down collagen in your connective tissue.”

“Clinician expertise and having done this makes a big difference. Some people are more sensitive to this enzyme, so there’s a chance for atrophy of the skin. I can see this happening in unsupervised med spas.”

– Teo Soleymani, UCLA Health

Until more is known about potential complications from Qwo, those who opt to try it should carefully consider the source.

“Theoretically, if you inject it too shallow or not at the right angle, you can place this collagenase in the dermis and that can cause poor outcomes in the skin,” Soleymani said. “That’s where clinician expertise and having done this makes a big difference. Some people are more sensitive to this enzyme, so there’s a chance for atrophy of the skin. I can see this happening in unsupervised med spas.”

“Unfortunately, in academia, I deal with a lot of complications that arise from these kinds of treatments, like contour deformities and fat necrosis, and they’re hard to treat. We can’t always predict the outcomes of these treatments,” Rezak said.

If you decide to try Qwo, these experts agree that you should find someone who can take your medical history into account and is highly qualified to perform the injections.

“For all types of injectables, I recommend getting them from a board-certified dermatologist or board-certified plastic surgeon. Side effects and complications are rare, but you want someone familiar with the anatomy who can manage complications,” Waldman said.

Most importantly, talk to your Qwo provider about whether the treatment is right for your body. Each patient, and each patient’s cellulite, is unique.

“Unfortunately, it’s not a magic bullet for all cellulite,” Soleymani said. “The right patient selection is critical, as it is with every cosmetic treatment. It’s nice for people who have a few small problem areas who don’t want to undergo bigger, more involved procedures, but with the understanding that you’re going to get less effective treatment overall. If you’re someone who has a lot of dimpling or have already tried body contouring or laser-assisted cellulite reduction, this may not work great for you.”

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