ATX-101 Archives | The Aesthetic Clinique

This coming year is an exciting one with a couple new FDA approvals expected. It’s also going to see several procedures fade away and new approaches with the “gold standards”.

Kythera’s ATX-101 will be approved for reducing the double chin fat using only an injection. The procedure will need to be repeated 3-5 times in most people, but there will be no incisions and minimal risks. Side effects will be swelling and discomfort that will last maybe up to a week. Off label, it could be used for fat in the belly, love handles, or thighs.
Longer acting dermal fillers for total facial volumization will catch on. Fillers such as Voluma, Sculptra, and Artefill can be used to add volume to the temples, cheeks, midface, jawline, and preauricular area. Even earlobes can use a little volume in most people. Very little side effects other than swelling and bruising are noted with these “Liquid Facelifts”, particularly when blunt cannulas are used. Results are instant with Voluma and Artefill, and gradual with the Sculptra. Duration of improvement is about 2 years with Voluma, 2-3 years or longer with Sculptra, and over 5 years (some doctors may say permanent) with the Artefill.
Botox administration will be “lighter” to give a more natural look. No more frozen faces leaving people expressionless. Particularly in the forehead, less Botox using a “micro injection” technique, means more movement and less risk of dropping the brows. The downside to this lighter dosing is that its duration will be slightly less.
A new topical neuromodulator, Revance’s RT001, will be FDA approved in 2014. Unfortunately, this won’t eliminate all the injections. It will be great for the crows feet area and possible for reducing underarm sweat though. It still will be administered in the doctor’s office (not for in home use).
Tattoo removal will become easier with less trips to the doctors office. With new protocols like the R20 and R0, several treatments (up to 4) can be combined into one office visit. It looks like the side effects and risks are the same as doing only one treatment per visit. The Picosure laser seems to also lead to faster ink removal but it is still too expensive to be widely available.
RF (radiofrequency) skin tightening will become even more popular, spurred on by microneedling devices which are more effective than transcutaneous ones. Being able to drive the RF energy to deeper levels both safely and reliably, as with the Infini, will lead to better and more predictable results. The other RF devices such as Thermage, Exilis, Pelleve and Tripolar will become less and less relevant as consumers are disappointed by their results.
There will be even more interest in noninvasive fat removal. Lead by Coolsculpting, people will find that having no downtime, minimal risks, and getting real observable fat loss is better than getting liposuction. Certain areas such as outer thighs have been difficult to treat noninvasively but new attachments with Coolsculpting and/or new devices using high frequency ultrasound (HIFU) might be developed to treat all the areas that liposuction traditionally treats. RF fat reduction will also become more popular because they will be more effective than prior versions. Zerona will lose all relevance due to its lack of sustained results.
Lip enhancements will be smaller and done using blunt cannulas. It seems like the trend for having your lips enter the room before you do is waning. People want to look like they have naturally beautiful lips and not obviously overdone lips. Using blunt cannulas enables one to have minimal downtime, minimal discomfort, and a naturally enhanced look.
People will become more concerned with anti-aging procedures of the hands and chest. Volumization using Sculptra in the declotage and Radiesse in the hands will become popular. Skin tightening using the Infini RF device will help with the wrinkles. Spots can be improved with the Fraxel Dual or Q-switched laser.
Tear trough injection will be the most popular area treated with dermal fillers. Blunt cannulas make this procedure both comfortable, safe, and quick. Restylane is the filler of choice for this area. By treating the tear trough and upper cheek, the nasolabial folds (smile lines) actually improve as well due to the lifting from above. Patients will have some swelling in most cases for a couple days which can be reduced by sleeping elevated. Bruising is minimal or none with the cannulas when compared to the needles which almost always has bruising lasting up to a week or more.
Men will do more cosmetic procedures. The drivers for this will be the competitive jobs market and the “no downtime” procedures. Sometimes experience isn’t all that is needed to land a job. To compete with the younger job seekers, the more “experienced” men are seeking procedures that can improve their looks, yet not keep them out of the public for very long. Botox, fillers, Ulthera, and Coolsculpting will become even more popular for men.
The number of people getting facelifts will continue to drop. With the improvements in skin tightening by Ulthera and full face volumization with dermal fillers, particularly collagen stimulators (Artefill and Sculptra) the aging face can be more naturally improved. There will be a trend for younger patients to start anti-aging treatments earlier leading to “more graceful” aging. People are not as willing to undergo the knife given the associated risks, downtime, and potential for undesirable results.
Artefill, a permanent filler that stimulates collagen, will gradually replace fat grafting for the face. As an off the shelf solution, Artefill is much more attractive to the patient than undergoing 2 procedures for fat; fat harvesting and then grafting. Also, fat is not always predictable with its “take”, and there can be a need for more than one procedure. Fine tuning with fat is also somewhat difficult and is much easier with Artefill. The apprehension behind the permanent aspect of Artefill has not been borne out and more of the well known injectors are warming up to Artefill.
Hydroquinones will gradually be replaced by other products to help with pigmentary problems. This trend started in Europe and South America. They have banned hydroquinones because of concerns over their potential carcinogenicity (even though there have been no known documented cancers from hydroquinones), ochronosis (pigmentation side effect that is very difficult to treat), and possible rebound hyperpigmentation. SkinMedica’s Lytera and Neocutis Perle will become acceptable replacements.

Dr. Steven Weiner is a Board Certified Facial Plastic Surgeon practicing in Santa Rosa Beach, Florida, between Destin and Panama City Beach, Florida. After laying down his scalpel in 2005 he has devoted his practice to Lasers and Injectables.

Blog: http://stevenfweinermd.wordpress.com/

YouTube: http://www.youtube.com/user/StevenFWeinerFacial

Website: http://www.theclinique.net

Press Release regarding these predictions by Dr. Weiner.

UPDATE: FDA APPROVED 4/29/2015, Now known as “Kybella”

UPDATE: KYTH Bought out by Allergan. Price of stock at time of original blog: 41.95, buyout price over 75

Kythera announced yesterday (9/16/2013) that they had 2 phase 3 studies for fat reduction in the submental area (underneath the chin) or “double chin” with just injections with their product ATX-101. The results were very positive, with 70% having one grade of change and 13.4% having 2 grades or more change. No serious side effects were noted. Minor side effects were discomfort and swelling which resolved. Another interesting positive outcome were the patient’s subjective scores on “happiness, self consciousness, feeling old, overweight, embarrassment, and being bothered” were all improved to the positive, several fold over the placebo. The results were sustainable as well with 90% still improved at 2 years and 80% sustaining benefits after 3 and 4 years.

Why is this a big deal? We can now destroy fat noninvasively with just injections. Granted, ATX-101 will probably only be useful for small areas of fat but it opens the door for off label use in areas other than the chin. Mesotherapy, multiple small injections to dissolve fat deposits, which has been done with non FDA approved products in the past, can now be somewhat legitimized with using FDA approved ATX-101, when and if it is approved. I suspect that ATX-101 will be approved in 2014 and late 2014 it will be in the hands of all the cosmetic physicians in the country. Soon there will be courses and experts, using the product all over the body for contouring. Heck, to have injections instead of liposuction, its a no brainer.

Another possible off label use for ATX-101 is for lipomas, benign fatty tumors, usually fairly superficial and slow growing. For those not wanting to have surgery and the scar that would follow, lipomas could be controlled with injections of ATX-101. Some people have multiple lipomas and the thought of having scars all over their body is not as attractive as getting injections to keep them “at bay” or make smaller.

There will still be a place for liposuction and Coolsculpting because the larger areas of fatty deposits won’t be treatable with ATX-101.

Looking for a good investment, buy KYTH. I suspect that this is quickly bought up by either Allergan (AGN) or Valeant (VRX) who both have cosmetic injectables (Botox, Restylane, Juvederm, Sculptra, Dysport) that would love to add this to their product lines.

The Aesthetic Clinique, and Dr. Steve Weiner, MD, Facial Plastic Surgeon, will be one of the first to have Kythera’s ATX-101 when it is FDA approved in 2014. For more information about Dr. Weiner and The Aesthetic Clinique, see http://www.theclinique.net