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“What’s unique about this device is that I can see results without any downtime,” Dr. Ortiz, director of laser and cosmetic dermatology at the University of California, San Diego, said during a virtual course on laser and aesthetic skin therapy. “Most other devices are not like that. It was well tolerated; there was minimal pain. There was no postinflammatory hyperpigmentation; it really is customizable to the patients’ needs.”
First cleared by the Food and Drug Administration in 2016 to remove benign lesions of the skin, Glacial Rx received an expanded indication in 2020 to temporarily reduce pain, swelling, and inflammation. The device, which was developed by R2 Technologies, relies on cryomodulation, a concept developed at Massachusetts General Hospital and the, Boston, to improve skin appearance and freeze melanin at the source. “Cryomodulation pauses melanin production, but the melanocyte function is preserved, the epidermal barrier is not disrupted, and there is no persistent inflammatory response, which is key, because it decreases the risk of postinflammatory hyperpigmentation, especially in darker skin types,” Dr. Ortiz said.
Here’s how it works: The handpiece of the device is placed on top of the skin and cooling is delivered to targeted solar lentigos and other benign lesions. Ice nucleation takes place within the dendrites. As cell turnover takes place, melanin-free cells migrate upward and appear as new skin. “Clinically, this appears as clearance of the lesion,” Dr. Ortiz said.
She discussed her clinical experience treating 15 patients with a beta version of the device. Since that time, Glacial Rx was redesigned to include a smaller-tipped handpiece, easier and faster prep time, and a proprietary water-based gel to facilitate ice crystal propagation, which is applied to the targeted lesions just prior to treatment.
For the trial at UCSD, the researchers performed 29 treatment sessions on 15 patients with Fitzpatrick skin types I-IV, to gain clinical experience and evaluate the effectiveness of the device. They found that the treatment was well tolerated, with minimal discomfort. The amount of heat extracted ranged from 107 to 166 kJ/cm2. No long-term dyschromia was observed, and some patients had lesion clearance after just one treatment.
“The settings are able to be titrated to where you have zero downtime, but you still get a lightening effect,” Dr. Ortiz said during the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “With other devices such as intense pulsed light, if you don’t see darkening than it probably didn’t work. With this device, you can titrate the length of the cooling and the temperature of the cooling.”
Posttreatment side effects commonly observed in the study were mild erythema, swelling, itching, and darkening. “There was minimal erythema in the higher settings, and some reports of itching and transient darkening in some of the higher settings,” she said.
Future indications for Glacial Rx may include psoriasis, acne, and rosacea. “We did try to use this for melasma,” she said. “It was effective, but I wouldn’t say it’s a cure for melasma. Melasma is very stubborn and requires a combination treatment, but it’s something we can use in our armamentarium.”
Dr. Ortiz reported having received consulting fees from R2 Technologies. She has been a paid consultant for and has received equipment from many device companies.