The FDA May Soon Regulate At-Home Microneedling on Skin
By now, you’ve probably heard of microneedling — a process in which a specialized device is used to create microscopic holes in the skin — and its potential skin-smoothing, scar-reducing, and pigment-fading benefits. And while the treatment has become a highly popular request at the dermatologist’s office, many are seeking ways to perform the treatment in the comfort of their own homes, too. Because of this, the Food and Drug Administration might soon be stepping in. The agency recently announced it wants to begin regulating the use of at-home microneedling devices due to perceived risks — here’s what you need to know.
Within the last couple of years, microneedling has become readily available for at-home use via handheld devices, but dermatologists aren’t too keen on the whole DIY movement, which, when performed by a medical professional, punctures microscopic holes in the skin, creating, “micro-injury that stimulates new collagen, resulting in improvement of skin texture, fine lines, pigmentation and scar remolding,” says Patricia Wexler, a New York City dermatologist. “Home devices do not give the same degree of sterility, or uniformity of application.”
“The at-home user may also not be aware of contraindications, such as herpes infection, an acne breakout, a psoriasis flair, a rosacea flair, an open wound, and active skin cancer, or recent chemotherapy,” she says. Keloids (raised scars) can also be a contraindication, which is why Wexler stresses the importance of understanding that any wound has the potential to create a scar, which essentially negates the efforts of microneedling.
Shari Marchbein, a dermatologist and clinical assistant professor of dermatology at New York University School of Medicine, echoes a similar sentiment. While she recognizes that at-home dermarollers might be less expensive and more convenient, “their safety and efficacy are something that requires further scrutiny.” In regard to their efficacy, she explains that with at-home devices, the needles range in lengths of .2 millimeters to 1 millimeter, which leads them to create more superficial wounds than those that would occur from an in-office professional treatment.
“As such, at-home treatments would not have any significant impact on conditions, such as acne scars and wrinkles, but may produce a superficial exfoliation and brightening/rejuvenation of the skin and can be done two to three times per week,” says Marchbein. “Additionally, if an inappropriate technique is used, or if the needles are not sharp enough, there is a risk of causing superficial tears to the skin.”
To prevent such risks, the FDA released a draft guidance in September, which states some microneedling tools are considered “medical devices,” and thus might be subject to the agency’s regulations and processes in the future. “We issued this draft guidance in fulfillment of our public health mission,” a representative from the FDA tells Allure. “Based on the information currently available, [the agency] considers risks associated with the devices to include, ‘infection, nerve and blood vessel damage, disease transmission between users, scar formation, hyper-pigmentation, skin inflammation, allergic reactions and skin irritation… This draft guidance provides recommendations to manufacturers to consider prior to submitting any microneedling products for FDA review.”
So, what does this all mean? Following the draft guidance, the FDA will begin reviewing comments received in response to the draft guidance and says, “once we finalize reviewing the comments, we will issue our final guidance.” Bottom line: Stay tuned.
For now, if you have an at-home dermaroller, check its labeling. If the device claims the following, according to the FDA, it’s considered a medical tool: “Treat scars, treat wrinkles and deep facial lines, treats cellulite and stretch marks, treats acne, dermatoses alopecia, stimulate collagen production or angiogenesis, and promote wound healing.” These claims have not been reviewed by the FDA at this time.
On the flip side, devices that are not deemed medical tools are those that claim to: “Facilitate exfoliation, improve skin’s appearance, and give skin a smoother look and/or feel, or give skin a luminous look.” (For more information on the FDA’s involvement in microneedling or to check the status of your at-home device, resources are available here in its draft guidance.)
Medical tool or not, if you’re still insistent upon at-home use, both doctors offer important advice. Marchbein warns to thoroughly cleanse the skin and ensure the dermaroller is clean, to be very cautious of that are applied directly before or after as they penetrate more deeply and can cause heightened irritation, to not use the device if you have a history of keloid scarring or if there is an active infection such as a cold sore or acne breakout, and to avoid the thin, sensitive skin of the upper and lower eyelids.
Wexler advises to keep the depth of the needle in at-home treatments under 1 millimeter and to “avoid treatments more than once monthly. Do not apply with firm pressure. Do not provoke more than pinpoint bleeding, and avoid make up for two days and continue sunscreen for several weeks.”
However, you can also skip the DIY dermarolling sesh for an in-office treatment, which involves “repeatedly puncturing the skin with tiny sterile needles that penetrate to various depths in order to create a controlled skin injury to rejuvenate the skin,” says Marchbein. When it’s performed in a physician’s office, “microneedling is nearly painless as a topical anesthetic cream is applied prior to treatment and some swelling and redness are expected for a few days post-procedure.”
As the treatment is a mechanical process that does not use heat, it’s safe for any skin color also, and Marchbein advises it is often paired with topical treatments which contain growth factors. For some, this can be their own platelet-rich plasma (PRP), within the treatment of a “vampire facial”. Or, topical applications can be those containing antioxidants like vitamin C. “By applying treatments both prior to and after the procedure, these ingredients are able to bypass the top layer of skin and directly enter the dermal layer, increasing their concentration and boosting their efficacy.”
The frequency of treatments varies and depends on the intention behind the treatment, says Marchbein. “As with lasers, in-office microneedling should be done monthly for three to six months to treat acne scarring as new collagen continues to be built, whereas it can be done a few times a year to help rejuvenate the skin and keep a more youthful appearance.”
She also advises that patients should avoid using Retin-A or hydroquinone for three days prior to treatment, and then wait two weeks after Botox and 28 days after filler. Costs for the treatment vary greatly and can range from $750 per treatment session to $1,500 with microneedling and PRP.
Article by Erin Nicole Celletti