CARLSBAD, CALIF. — at 1 year.
“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”
Dr. Arash Moradzadeh
AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.
The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.
Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”
Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”
During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”
For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.
In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”
Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”
Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”
The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”
Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.
A version of this article first appeared on Medscape.com.