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New treatment for infraorbital hollowing | The Chronicle of Skin & Allergy - July, 2013

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New treatment for infraorbital hollowing

Study shows Restylane Eyelight™ has long-lasting results to 12 months

Canadian patients will now have the option of a new treatment for infraorbital hollowing, commonly known as dark shadows. Restylane’s® Eyelight™, a hyaluronic acid (HA) filler, is designed to decrease the under-eye grooves that develop because of a lack of volume and volume loss in the area under the eye, improving periorbital aesthetics.

Dermatologists who are early adopters of this HA dermal filler are impressed by its treatment effects, its robust safety, and point out that subjects in studies and patients in real-world clinical practice have provided highly positive feedback about outcomes with the filler.

How it Works

The HA dermal filler uses non-animal stabilized hyaluronic acid (NASHA) that offers increased firmness and the ability to remain in the injected site. “The gel technology is a little bit firmer [than other hyaluronic acid fillers],” said Dr. Carolyn Jacob, a dermatologist and Medical Director at Chicago Cosmetic Surgery and Dermatology in Chicago. “It stays in place and does what it’s going to do without flattening or spreading, which some of the other types of hyaluronic acid technology tend to do a little bit more.”

Patients sometimes express concerns about the migration of fillers, particularly when they see social media posts about the topic, but filler migration does not occur with Eyelight™, noted Dr. Jacob. “Patients have said to us in office that ‘I heard that fillers migrate’,” Dr. Jacob told THE CHRONICLE OF COSMETIC MEDICINE + SURGERY. “This is not a filler that is going to migrate. There is a lot out there in social media about filler feeling like it’s in some other different place [than the injected site]. There were no reports of migration because this product doesn’t migrate.”

Another characteristic of the product is that it does not readily absorb water, which curtails the potential for swelling, noted Dr. Jacob. “It doesn’t over-absorb water, so you shouldn’t get an abundant amount of swelling from it,” she said.

Dr. Lisa Kellett, a dermatologist at DLK on Avenue in Toronto, agreed that the composition of Eyelight™ minimizes the risk of puffiness. “You do not want a product that is going to draw a lot of water in that area,” said Dr. Kellett. “That is the beauty of the product, it’s low hydrophilic nature. It also has high G-prime.

Other advantages of the product are that it is very exact and delivers an accurate outcome, an important trait considering the site of injection, said Dr. Kellett. “It’s a precise product, and it gives you targeted definition,” she added. “In this area the skin is very thin, so you have to be very careful. Because it can be quite an unforgiving area.”

Comparing the impact of needle vs. cannula

Published research has demonstrated the effects of the filler using a needle versus using a cannula show no difference in the
efficacy of the filler, regardless of the injection tool used. Studies have been designed comparing the effects of Eyelight™ using cannula vs. filler, to address preferences that some injectors have for needles and that others have for cannulas (Aesthetic Surg J 2022 Feb 15; 42(3):285-297).

This study, published in Feb. 2022, was a prospective, randomized-controlled, evaluator-blinded investigation of 42 patients with a mean age of 44 years and compared the impact of needle vs. cannula injection at baseline and then results at four weeks post-treatment. Patients underwent two treatment sessions, spaced two weeks apart, and then attended a follow-up visit at Week 4.

Scales such as the GAIS (Global Aesthetic Improvement Scale), a seven-point scale that measures the improvement or worsening of a patient’s appearance relative to baseline, and the GIHS (Galderma Infraorbital Hollows Scale), a four-point photo-numeric scale designed to assess the severity of infraorbital hollowing from 0=none; 1=mild; 2=moderate; and 3=severe, were
used in this study.

In this study, GIHS improvement was defined by at least a one-point decrease from baseline on either side of the face. GAIS improvement was designated by any score above zero (denoting no change) at all follow-up visits.

Adverse events reported in this study included ecchymosis, edema, erythema, and pain, and were linked to the injection
technique rather than Eyelight™ itself. All adverse events in that study resolved in two weeks. Of note, there were no cases of the
Tyndall Effect (bluish discolouration) observed in any case in the study.

In a subsequent study including 333 patients that also compared the impact of cannula vs. needle with the injection of Eyelight™, most subjects (283) completed the entire study and 87.4% of patients achieved correction of the infraorbital
hollows at the pivotal three months.

“A study with cannula versus needle basically showed that the responder rates were similar via a cannula or via a needle,” said Dr. Kellett. “The adverse events were very similar too.”

In real-world practice, Dr. Jacob noted her patients report they experience very mild pain with injection. Using a scale of one to  10, with one being no pain, people typically rate injection with Eyelight™ at two in real-world practice, she said.

“Patients might feel a little pressure, a little movement, but it is not really [painful], even though we're coming really close to the eye area, and that might seem daunting. It is done in a very careful, practiced way that does not require a lot of needle pokes,” said Dr. Jacob.

Because of the possibility of swelling and bruising, Dr. Jacob recommends that patients time their treatment between social occasions or professional commitments.

“We will tell people to schedule this [treatment] around your big events because we don’t want to have you either dealing with a possibility of a bruise or possibility of swelling,” said Dr. Jacob.

“We have ways to mitigate the bruising by using a cream called Alastin INhance, which also helps to decrease swelling. It is a nice additional thing that we can do here in the office. Patients can take it home with them too. If they have something important at work on a Monday, then doing the treatment on a Friday is a really good idea.”

Dr. Jacob noted that delivery of the product under the eye using either a cannula or needle results in histamine release that  produces transient edema. “Because there's a poke of a needle or cannula, there is going to be a tiny bit of swelling just from that histamine release,” said Dr. Jacob. “But after that settles in, then you will really know what you are going to see [as a result of treatment].”

The number of injections required in a single treatment with Eyelight™, either with a needle or cannula, is tied to a patient’s  anatomy, explained Dr. Kellett. “It is difficult to say [how many injections will be needed],” she said. “It is totally dependent on the patient.” In terms of stopping any medications prior to treatment, Dr. Kellett does not advise patients to halt taking medical therapies that are preventive against any acute events.

“For my patients who say they are on blood thinners to prevent blood clots or for other reasons, I don’t ask them to stop taking these medications,” said Dr. Kellett. “I just tell them that they may have more puffiness and bruising [after treatment].”

Treating darker skin types

Clinical studies with Eyelight™ included a diversity of patients of different races to assess the impact of treatment in patients of  all skin types.

According to Dr. Jacob, there are considerations in using Eyelight™ in patients of colour. There can be much peri-orbital  hyperpigmentation, owing to either sun exposure or genetics, in patients of colour, particularly with aging, she explained. “We
tend to see that [peri-orbital hyperpigmentation] as patients get older.”

If there is existing dyspigmentation under the eye in a patient with skin of colour, that dyspigmentation should first be  addressed before injection of Eyelight™, added Dr. Jacob. “We can take the hollows out, but we also have to lighten the discolouration,” she said.

Patient selection and patient satisfaction with treatment

Patient selection is critical to success with Eyelight™ treatment, Dr. Kellett stressed. “You want to make sure that patients would be those where the filler would add some volume, address dark circles, address some medial or lateral cheek volume loss and address a tired look,” said Dr. Kellett. “Those are patients who are good candidates.

“Candidates who are not as good would be those who have chronic edema around their eyes, those who would have moderate-to-severe skin laxity, those who have herniation of the fat pads, those who have poor skin quality, and those who have dyspigmentation of the skin,” she added. Patients treated with Eyelight™ have expressed a high degree of satisfaction in research studies, noted Dr. Kellett.

“Patient satisfaction rates at month 12 were very high,” said Dr. Kellett. “They found that patients felt better about themselves, felt happier, more attractive, and more confident. They had a higher overall improved satisfaction with their appearance.
They also had reduced hollows under their eyes.”

Evaluations that were held 12 months after the first treatment indicated that 84% of patients remained pleased with results, 89% thought the results looked natural, and 79% expressed that they thought they looked less tired. When asked if they would recommend Eyelight™ to a friend, 94% of respondents who were treated with Eyelight™ said they would recommend it to a friend and would repeat treatment.

Dr. Jacob echoed Dr. Kellett’s view of the longevity of the treatment effect of Eyelight™.

“We have the confidence to let people know that this is a product that’s going to be great for usage because we’ve now shown  follow-up to 18 months in a study, and found that after optimal treatment, these patients are still experiencing improvements from it,” said Dr. Jacob.

DLK on Avenue