BBI Contributing Editor

The market for acne treatment devices is heating up as innovative products offer physicians and their patients viable options other than medications.

One such product is the CoolTouch, a 1320 nm laser from CoolTouch (Roseville, California) that is used to treat active acne. "For several years now, we've been treating photoaging and acne scarring with the CoolTouch, with very pleasing results," said Jeffrey Dover, MD, director of SkinCare Physicians of Chestnut Hill (Boston, Massachusetts). "We have very high success rates for acne scarring, based on patient satisfaction." There is usually a series of six treatments at one-month intervals. Topical Ela-Max anesthesia is commonly applied one hour before each session.

The CoolTouch device received FDA clearance in May for treating active acne. "We've been very encouraged by results in treating moderate-to-severe acne," said Dover, who also is an associate clinical professor of dermatology at Yale School of Medicine (New Haven, Connecticut). "I've seen some surprisingly good results in young men or women who either have acne scarring or have no acne scarring at all." Some of his patients obtain results with only a single treatment. "But we tell patients they will likely need at least three sessions before they will see noticeable improvement," said Dover. Meanwhile, "we almost always institute traditional medical therapies at the same time. However, even without adjunctive therapy, we have nice results."

When Dover first heard about the use of devices to treat acne, he was a naysayer, in part because "treatment is not covered by insurance plans. However, the truth is that families are fed up with medications that are ineffective. They are willing to pay out of pocket for these new treatments."

The OmniLux LED system from PhotoTherapeutics (Manchester, UK) is a single platform that drives two interchangeable treatments lamp heads. The Blue head (410 nm to 415 nm blue light) is designed for treating mild-to-moderate acne vulgaris.

"Patients simply place their faces under a light source," said Sandeep Cliff, MD, a consultant dermatologist at Surrey Sussex NHS Trust (Surrey, UK). "It is very user-friendly, with no adverse events." The blue light wavelength actives protoporphyrin, which is a product produced by the acne bacteria. "This destroys the acne lesions," Cliff explained. "Our approach is to use the natural products produced by the acne bacteria to actually treat the skin," he said. "Unlike systemic drug therapy, which produces an effect on the entire body, the OmniLux is specifically targeted to the acne lesions themselves. It is very specific and a more natural treatment."

Sessions are twice a week (about 20 minutes each). A study involving four weeks of treatment found, on average, a 73% reduction in the number of acne lesions. "The treatment is very well tolerated by patients," Cliff said. In addition, "patients don't have to take tablets or apply potentially irritating lotions to their skins, as with traditional therapies." The risk of resistance from antibiotics is "virtually eliminated as well," he said. "Today, practitioners and patients are very conscious about the potential side effects and risks of taking any kind of drug therapy. I expect devices will become more popular as people see the virtues of these alternative modalities." The OmniLux, in particular, offers patients "a much more homeopathic, holistic approach to treating their skin," Cliff added.

The ClearLight Acne PhotoClearing System from Lumenis (Pleasanton, California) is a high-intensity blue light device for the treatment of moderate inflammatory acne. "This is a completely novel way to treat inflammatory acne, without requiring any systemic medications or even using devices that are painful or ineffective," said Vic Narurkar, MD, director at the Bay Area Laser Institute (San Francisco, California). "I like to refer to the technology as 'endogenous photodynamic therapy.' This light stimulates the acne bacteria to overproduce porphyrins which then kills the bacteria, thus reducing the acne lesions." Any skin type can be treated, and the light source causes no damage to human skin. "This is very different from lasers or other light sources, where there is always a risk that melanin or the sebaceous glands may be damaged," he said.

Narurkar uses two different protocols with the ClearLight that are equally effective: twice a week (15-minutes sessions) for four weeks or once a week (23-minute sessions) for eight weeks. In a study of about 100 patients, "the overall statistical clearance rate was 70%," said Narurkar, who presented these clinical results at the annual meeting of the American Society of Medical and Laser Surgery in Anaheim, California. "But I would say 100% of patients see an effect." The earliest recurrence occurs about three months following final treatment. "We've also had a few patients with clearance up to six months," he said.

According to Narurkar, who also is an assistant clinical professor of dermatology at the University of California-Davis Medical Center (Davis, California), the future of acne treatment lies in non-invasive or minimally-invasive therapies "that affect the pathogens of acne without destruction of anything on the skin. I see even the possibility of hand-held devices." However, since acne is a multi-factorial disease, "there is going to be a need for more than one modality of treatment," he predicted. "Light sources are just one piece of the puzzle. Subsets of patients will likely require Accutane or its derivatives. Topical therapy is also integral." After treatments with ClearLight, Narurkar maintains patients on topical benzoyl peroxide and clindamycin.

The ThermaCool TC System from Thermage (Hayward, California) uses a unique form of radiofrequency energy. "In most patients, one treatment makes a big difference," said Javier Ruiz-Esparza, MD, an associate clinical professor of dermatology at the University of California, San Diego. "We believe we achieve good results because of the intense heat created in the dermis, which is significantly greater than with lasers. But we don't know the mechanism of action for acne. It may be that we reduce the bacterial count or that we suppress the activity of the sebaceous glands."

In a study published in the April issue of Dermatologic Surgery, 22 patients (10 women, 12 men; ages 16-28) were treated with the ThermaCool device for moderate to severe acne scarring, cystic acne and active acne vulgaris. "Only nine of these 22 patients were on concomitant medical treatment," according to Ruiz-Esparza, the author. One treatment session was performed on 20 patients and two sessions on the remaining two patients (one month apart). Average fluence was 72 J/cm2. "There was an excellent response in 82% of patients, moderate response in 9%, and no response in 9%," he said.

In his clinical practice, Ruiz-Esparza waits four months before a second treatment. "Roughly 20% of patients need a second session," he said. On the other hand, "remission can be permanent or can reactivate to a lesser extent after one year. It makes a lot of sense to use devices because medications involve the consumption of a chemical substance." He added, "Taking medication can be risky, time-consuming, expensive and involve frequent visits to the doctor."

The SkinStation from Radiancy (Orangeburg, New York) combines a safe level of light energy and heat to treat acne. "I'm thrilled because this device is extremely effective in some people, thereby eliminating the need for oral treatment," said Ava Shamban, MD, a clinical assistant professor of dermatology at the University of California School of Medicine in Los Angeles. "SkinStation is a small, user-friendly device. Treatment is comfortable for the patient, and it doesn't require a topical anesthetic." The large spot size (22 mm by 55 mm) also is an advantage.

The proprietary LHE (light and heat energy) technology likely has two effects. "It is destructive to the bacteria by exciting the porphyrins," Shamban said. "I also feel there is a photochemical effect on the skin that helps to stimulate more cellular turnover and perhaps more immune-system response to the resolution of the inflammation." She schedules two sessions a week for four weeks with the SkinStation. "Patients who have more inflammatory acnes seem to have the best results." Shamban also participated in a formal study of 15 patients who completed therapy. One-third of those patients achieved excellent results, one-third had moderate results, and one-third showed minimal results.

"I think the treatment of acne is going to become more sophisticated," Shamban predicted. "Ideally, we will be able to match up patients with specific treatments for optimal results. The fact that we can add both laser and intense pulse light (IPL) systems to our armamentarium makes a difficult condition easier to treat." Furthermore, "people are always interested in what is new and fresh, despite having to pay out of pocket."

The Smoothbeam system from Candela (Wayland, Massachusetts) is a 1450 nm diode laser that thermally alters the sebaceous glands at the sites where acne lesions occur. Besides achieving an improvement in inflammatory and comedonal acne, Smoothbeam "can safely treat all skin types, regardless of pigmentation," said Arielle Kauvar, MD, a clinical associate professor of dermatology at New York University School of Medicine (New York). The 1450 nm wavelength permits "temporary heat damage to the sebaceous glands. Most patients notice a decrease in oiliness following treatment, which correlates with our impression of the mechanism of action," she noted. The proposed mechanism of action is an alteration in the sebaceous glands, resulting in a decrease in sebum production.

Kauvar typically treats her acne patients three to five times, at intervals of three to four weeks. Overall, "80% to 90% of patients after three to five treatments see greater than 75% improvement in their acne," she said. "However, I don't have long enough follow-up to know the actual length of remission. This is something I'm currently evaluating." Nonetheless, many of her patients have remained in remission for at least six months. "The Smoothbeam can also simultaneously improve acne scarring, so this is an excellent treatment in the young-adult population who have had acne in the past," Kauvar noted. In contrast, oral and topical antibiotics "don't appear to help that much in many patients. Patients tend to end up with very complicated regimens."

In the future, Kauvar envisions device technology that targets both bacteria-causing acne and the sebaceous glands. "I think we will see greatly improved results using this combination," she said.

Levulan photodynamic therapy (PDT) from DUSA Pharmaceuticals (Wilmington, Massachusetts) has been shown to effectively treat acne by clinical researchers. According to Mark Nestor, MD, PhD, a clinical associate professor of dermatology and dermatologic surgery at the University of Miami School of Medicine (Miami, Florida), "myself and others have had really outstanding results overall in treating patients with moderate to severe acne." Prior to Levulan, "the only treatment that showed such good results was Accutane," he said. "But Accutane has a lot of limitations, especially in women and more specifically in young women. Many patients achieve comparable results with Levulan, without the systemic side effects."

Nestor normally schedules a series of three treatments with Levulan (about three weeks apart). "We start with a light microdermabrasion," he said. Levulan is then applied 30 to 60 minutes before the light source. Depending on the patient's skin type, a pulsed dye laser or IPL is used. "Patients with darker skin do better with IPL because of the slightly longer wavelengths that allow for better penetration." An entire treatment session lasts about one hour.

After three treatments, "virtually every patient eventually has significant improvement in both moderate and severe cystic acne," Nestor said. The light source "also tends to help the scarring, so there is a two-pronged benefit for the patient. The only problem patients encounter is a few days of a sunburn-type reaction. But this has not been an issue."

This summer, the AcneLift system from Inner Act (Reno, Nevada) was introduced. Featuring two LED multi-probes, the AcneLift treatment protocol consists of 30-minute sessions (twice a week). "We've seen great results with only two treatments, but some patients require a total of six sessions," said Steve Zinnel, director of marketing for the company. "Results are excellent. We're able to clear even cystic active acne very quickly." Periodic maintenance sessions are required. "The AcneLift does not cure acne; rather it attacks the bacterium that causes acne," he explained. Remission normally lasts three to six months with the LED light therapy.

"This technology is definitely affordable at $7,488," Zinnel said. "The procedure is also painless and safe. It can be performed either in a doctor's office or by an aesthetician." In the future, "there is going to be continued price pressure on devices to treat acne," he said. "There is also a place for both equipment and pharmaceuticals. But it is ultimately up to the physician to decide which therapies to use."