WHAT'S THE POINT? INNOVATIONS IN THE INJECTABLE SPACE

SUBCUTANEOUS RF TIGHTENING

Sabrina Fabi, MD

One of the newest additions to the minimally invasive “skin tightening” device arena is the ThermiTight by ThermiAesthetics. It employs temperature controlled RF via a fiber that is inserted subcutaneously to heat the dermal-hypodermal interface, bypassing the epidermis altogether. The system delivers MRF energy directly into the subdermal tissue through a 600-μm electrode enclosed in a 1mm cannula and extending 1-2mm beyond the distal end of the cannula. The internal temperature can be set to 60-70 Celcius (optimal temperature to achieve collagen denaturating), and an internal temperature monitor automatically turns off the system if the internal temperature exceeds the set temperature by 7 degrees Celsius. Simultaneously a forward looking infrared camera (FLIR) (FLIR E40, FLIR Systems, Inc.) allows for radiometric IR-video streaming with thermal monitoring of the entire epidermis in the treatment field rather than a single spot.

In our practice ThermiTight has proven useful to tighten lax skin of the arms, medial thighs, and abdomen in patients who are not ready or willing to undergo the morbidity, mortality, or scars that accompany a brachioplasty, thigh lift, or abdominoplasty. The probe runs through the subcutaneous plane, in-vitro.

TARGETED COLD THERAPY

Doris Day, MD

Iovera is a non-toxin procedure that may appeal to patients less interested in “toxin” therapy and all that that connotes. It comes with a unique set of plusses and minuses that are worth considering. Although physicians are not able to refine treatment with Iovera the way they can with toxins, this can be a positive, too. That comes with the territory of this being a more straightforward procedure and therefore doesn't require the kind of finessing to which physicians injecting toxins have become accustomed.

Regarding the frontalis muscle, specifically, toxins can actually be limiting in the sense that if you don't hit all points evenly, the results can be disproportionate. Additionally, you may also get some hyperdynamic movement in the areas you didn't hit. The effect of this can be a pulled brow or unevenness. Moreover, since the left and right sides of the frontalis are different, the same treatment will look different on one side than the other. With Iovera, however, you are targeting the branch of the nerve, and if one side is different you're still hitting the muscle on both sides equally. Therefore, your results will be consistent.

Thus, this procedure may be ideal for patients who want a smooth forehead but who don't want to have to come back to have it checked, since it can all be addressed in one visit in a reliable amount of time.

In terms of efficacy, the results of treatment with Iovera are immediate and noticeable, as noted in the clinical trials. In some cases, patients may need to return for retreatment if you didn't hit the nerve branch the first time. This is one drawback to performing a nerve block prior to treatment. If the effect wears off in a short amount of time, it is likely that you didn't hit the nerve branch with the procedure and the patient will need to return to the physician's office to have it treated.

However, with proper treatment, the results can be significant. Clinical trials showed that roughly 90 percent of patients treated with Iovera demonstrated one-point improvement at roughly 30 days after the procedure, while 70 percent achieved two-point improvement.

Targeted cold therapy presents several advantages. However, if approved, the procedure is unlikely to displace toxin procedures. But it may offer a reliable alternative for the percentage of patients who do not want to receive toxins. Moreover, the differences in how the procedure works gives both patients and clinicians new options for facial neuromodulation.

BELLAFILL AVAILABLE FOR ACNE SCARS

Bellafill (Suneva Medical) is now the only filler on the market approved for the treatment of acne scars. FDA granted approval for Bellafill to treat acne scars based on the outcomes of a double-blinded, randomized, placebo controlled pivotal study in which subjects were treated with Bellafill at 10 US clinical centers. Bellafill was found to be safe and effective when compared to subjects treated with a control saline injection.

The primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to control at six months. A responder was defined as a subject who had 50 percent or more of treated acne scars improve by two or more points on a validated four-point Acne Scar Rating Scale (ASRS). At six months, the response rate for Bellafill was 64 percent vs. 33 percent for Control (p=.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71 percent).

Secondary effectiveness endpoints were evaluated, where both investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through six months and unblinded at 12 months. Both groups rated appearance as improved, reaching statistical significance at every timepoint after the touch-up period (at week four) through six months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 84 percent of subjects were rated as improved at six months and 98 percent were improved at 12 months by an unblinded assessment. On the Subject Global Aesthetic Improvement Scale (SGAIS), 77 percent of subjects rated their appearance as improved at six months and 83 percent rated their appearance as improved at 12 months. In addition, subjects were asked to rate their level of satisfaction with acne scar correction treatment on a Subject Assessment of Scar Correction scale (SASC). At six months (blinded), 84 percent of subjects were satisfied while 90 percent were satisfied at 12 months (unblinded).

IN THE PIPELINE: ATX-101

ATX-101 (deoxycholic acid , Kythera Biopharmaceuticals, Inc.) is an injectable drug in clinical development for the reduction of submental fat, or “double chin.” In March, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to support the approval of ATX-101 injection for this indication.

The product recently met all primary and secondary endpoints in two Phase III trials: REFINE-1 and REFINE-2. The trials, conducted in the US and Canada, compared the efficacy and safety of a 2mg/cm² dose of ATX-101 versus placebo for the reduction of submental fat. The identical multicenter, doubleblind, randomized, placebo- controlled trials enrolled more than 1,000 subjects with moderate to severe submental fat. Based on validated rating scales used to evaluate primary efficacy endpoints at 12 weeks, active treatment with ATX-101 produced at least a one-grade improvement in both clinician and patient ratings in 70.3 percent (REFINE-1) and 66.9 percent (REFINE-2) of subjects, versus 18.7 percent and 22.4 percent of controls, respectively. Analysis showed that 13.4 percent of treated subjects in REFINE-1 and 18.7 percent of subjects in REFINE-2 had an improvement of at least two grades on both clinician and patient rating scales, versus zero percent and 3.2 percent of controls, respectively.

Patient-Reported Submental Fat Impact Scale (PR-SMFIS, a secondary endpoint) scores showed that treated subjects were statistically significantly more likely to perceive themselves to be happier, less bothered, less self-conscious, less embarrassed, younger or less overweight after treatment with ATX-101.

FINER DETAILS: NEW ADVANCES IN LIP AUGMENTATION

With Kenneth Beer, MD

As an investigator on the trials for the recently approved Restylane Silk, can you give an overview of how this product works?

What sets Restylane Silk apart is that it's the first and only product approved for the treatment of lines around the lip. It's been approved for use in the lip as well as around the lip, so that's a little bit different. It's a very small particle, so that's another point of distinction compared to Restylane, so it's a much finer particle with which to paint. And, really, it's a wonderful product because it has anesthetic in it. In the studies, we saw that it provided a durable correction, where the majority of people had a noticeable change in their lips, even as late as six months. So what we've seen is that the product works and it continues to work. The degree of improvement we've seen (with blinded evaluators) was statistically significant and felt to be indicative of substantial change. We noticed it when we treated the lips and we noticed it when we treated the lines around the lips. Overall, there was a noticeable improvement pretty much across the board with this product.

What impact will more refined products like these have on the evolving aesthetic spectrum?

The significance is that, as we get more products that are finer to use, we can paint with smaller brushers and get the details a lot more precise. Before we had just one or two products, but the addition of these new products allows us to specifically target the lip with as a region of anatomic importance with a device that works very precisely.