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Dysport, with its recent FDA approval, offers a competitive product to Botox. Another neurotoxin for aesthetic use is highly welcomed by many as some are frustrated by the service and price that comes from a monopolistic manufacturer. As Dysport has become commercially available, rumors abound that it lasts longer than Botox and its price will be less.
To date, no large scale studies have been published that can support or refute these supposed properties that Dysport provides. In the November 2009 issue of Plastic and Reconstructive Surgery, Kane and colleagues have published results from the clinical trial that evaluated the effectiveness of Dysport for glabellar lines. I presume that this information is what made up most, if not all, of the manufacturer’s submitted clinical data to the FDA for consideration for approval.
This was a phase III, double-blind, placebo-controlled study that was conducted in 27 centers and involved 816 patients. Patients were stratified by race and received a single treatment with Dysport or a placebo based on a variable dose that differed for women and men. They were evaluated up to 150 days after treatment. In essence, this was a very well designed and conducted clinical study.
In reading the results, one can draw the following conclusions of clinical relevance. First, onset of the effects of Dysport were seen as early as 24 hours with a mean onset of 4 days. This does seem earlier than that of Botox and so the rumor that Dysport has an earlier onset of action does seem to be true. But it is not always within the first 24 hours but rather days. This means that it kicks in a few days earlier than Botox on average. The mean duration of effect for Dysport averaged slightly less than 110 days. When compared to Botox, this is a very comparable length of active time. The rumor that Dysport lasts longer than Botox appears to be just that…a rumor not fact. What is very interesting in the study is that the response and duration of action was slightly higher in African American patients. They do not speculate as to why.
A cost analysis was not done as part of this clinical study nor would it be appropriate for a clinical investigation. The study shows that there is not a dose comparison between Dysport and Botox as everyone knows. Given that the ‘average’ dose of Botox for the glabella is around 20 units, Dysport doses ranged from 50 to 80 units based on muscle mass and sex of the patient. That equals roughly 2.5 to 3 units of Dysport to 1 unit of Botox in dose administration. Knowing that ratio should help physicians and patients determine if they are getting a Dysport treatment that is equal to or less in cost than that of Botox.
The rumors that Dysport is ‘better’ than Botox are not substantiated in this large clinical study. It does show that it is just as effective and does offer a true competitive analogue. Whether it will cost less is determined completely by the pricing and incentives that your local provider may or may not give.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Botox and injectable fillers are the mainstay of non-surgical facial rejuvenation. Besides creating a relatively immediate change with less facial wrinkles and folds, they provide a great psychological boost to one’s self-image and sense of attractiveness. Often I see patients that undergo these treatments before a major event such as a child’s wedding or a class reunion, serving as a testament to their profound aesthetic benefits even if they are not permanent
While most patients having these treatments are doing them with long-term anti-aging purposes, some seek them to make themselves feel better for other reasons as well. The patient afflicted with cancer and undergoing chemotherapy and radiation treatments is one example. In my Indianapolis plastic surgery practice, I will occasionally see the cancer patient who is in some phase of their therapy who wants such treatments.
This raises the question of whether Botox and injectable fillers should be used in the cancer patient. This question is based on two concerns. Will these treatments be as effective as in the non-cancer patient and do they in any way interfere with the patient’s current cancer regimen? Before trying to answer these questions, one should address the immune status of the patient. Any cancer patient who has below normal white counts (a compromised immune system) should obviously not have any of these drugs injected into them. Adverse reactions, including infections, can potentially occur.
In the non-immunosuppressed patient, however, there is little information for or against their use. Based on my research, I can find no published contraindications to their use in patients with an intact immune system, even if they are undergoing active treatment. Similarly, there is no medical evidence that suggests the duration of the effects of Botox or injectable fillers is less in the chemotherapy or irradiated patient. My experience in these patients would indicate the same…no different than the typical aesthetic patient.
Cancer patients may seek aesthetic treatments as a boost to their shattered self-image and awareness of their own mortality. Check with their oncologist to determine their immune system status although most patient’s know their white count levels. There is no reported interactions between the localized facial effects of Botox and any of the injectable fillers and the systemic effects of chemotherapy in particular.
Barry L. Eppley, M.D., D.M.D.
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Three Adverse Effects of Botox and Dysport Injections into the Forehead
Author: barryeppley
Botox and Dysport are the single most effective non-surgical treatment of the face for wrinkle reduction and an overall anti-aging effect. It is fairly simple to inject and the large numbers of patients who are successfully and happily treated, by practitioners of a wide variety of educational backgrounds, is a testament to its effectiveness and excellent margin of safety.
But adverse effects with Botox and Dysport do occur and they are exclusively of the aesthetic type. True medical complications have not been reported with the doses used in the facial cosmetic patient. One of the potential negative effects of Botox is that it doesn’t work well or at all which may be a reflection of its age or dilution. But its potential for lack of effectiveness is not what I want to cover here.
The most dreaded and well known complication of injectable neuromuscular facial treatments is upper eyelid drooping, known as ptosis. This occurs when the toxin diffuses or migrates from an injection site in or around the eyebrows down into the upper eyelid. The position of the upper eyelid margin drops down, covering some portion of the iris. This is easily seen by all and no patient wants to walk around for months with an eyelid at ‘half-mast’. This results from injecting too close to the eyebrow or putting in large volume in an injection site near the eyebrow. Fortunately, eyelid ptosis is very uncommon as there is no known reversal or antidote to this problem other than letting it wear off.
One of the more frequently seen adverse effects is an unusual or unnatural looking forehead movements. When the area between the eyebrows (glabella) is treated, those pesky vertical lines and furrows will go away but the rest of the forehead is unaffected. For those with very active forehead movements, this can result in a central zone of paralysis amidst a sea of moving forehead areas. This may also make the eyebrows lift up in its mid- to lateral parts but not in the brow area closest to the nose. (known as a ‘Spock’ brow) These abnormal forehead movements can be easily managed by the judicious placement of injections in other areas of the forehead to soften those movements and create a less active but more symmetric movement of the forehead and brows.
The last adverse forehead effect is an undesired lowering of the eyebrows, also known as ptosis. When too many injections are done above the brow and across the forehead, the eyebrow may feel heavy and actually drop a little bit. The arch of the eyebrow may change as well. In some cases, placing injections high up along the scalp line may cause the eyebrow to raise although this is not always successful.
Botox and Dysport have a very profound reducing effect on facial muscle movements where they are injected. But forehead movements, eyebrow and eyelid positions all may be adversely effected by these injections and sometimes it is possible to have too much of a good thing. In somes cases, additional ‘balancing’ injections can be done to counteract how the muscle movements have been affected. When in doubt as to whether more injections can be effective, I prefer in my Indianapolis plastic surgery practice to first use a local anesthetic that lasts for 24 hours or so and see if the patient finds it helpful…before proceeding with the longer acting injections. Upper eyelid ptosis, however, is largely irreversible and must await the tincture of time.
Barry L. Eppley, M.D., D.M.D.
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Just when I thought every conceivable use of the muscle relaxer Botox had been envisioned, a new application gets proposed. Recent anectodal reports and a clinical paper now support the possibility that Botox helps clear acne. The injection of Botox directly into the skin has been shown to reduce large pores, oil production, and acne breakouts.
The basic cause of acne is due to the skin’s sebaceous glands which overproduce too much oil (sebum) into the skin’s pores. Sebum not only clogs the pores but it also serves as a source of nutrients for bacteria. When enough bacteria multiply, the pores become inflamed and a pimple is formed. Botox is theorized to be helpful for control of acne by blocking the chemical acetylcholine in the skin’s dermis. Acetylcholine helps stimulate the skin’s sebum production. By reducing sebum production, acne breakouts will be less. In addition, Botox paralyzes the little muscles that surround the skin’s pore which makes them expand, thus shrinking pore size.
Injecting small amounts of Botox into the skin is technically difficult. The thickness of most facial skin is around 1mm or so. The injections need to be just into this layer and not deeper, otherwise it will not work. If it is injected past the dermis, facial muscles may be paralyzed and could alter one’s facial expressions.
Botox remains an interesting and relatively cost-effective treatment for refractory adult acne cases. It should be pointed out that this is an off-label, non-FDA approved use of Botox and most of the supportive evidence is anectodal. I have yet to see a published prospective controlled clinical study that evaluates its effects in a larger number of patients with longer follow-up. But the concept is theoretically appealing and it seems to have no significant risks.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Botox or botulinum toxin A has a lot uses that go beyond facial wrinkle reduction. Some of these are well known and FDA-approved and others are not. One of the newer uses in plastic surgery has been in the nonsurgical management of masseter hypertrophy. While well known in the Eastern world, it is not as common in Western populations.
The muscle enlargement at the angle of the jaw gives one a square face or jaw look. In Asia, particularly Korean and Chinese populations, they have a naturally larger masseter muscles and broader bony jaw angles. When they become excessively so, which occurs in about 10 to 20% of the population, their face becomes too square or strong. This tendency appears to be a developmental or congenital one. . The incidence of masseteric hypertrophy in the Western population is unknown and is as likely to occur on just one side as it is bilateral. Many Caucasian patients have an associated history of bruxism or excessive jaw clenching which is clearly a contributing cause.
Masseteric hypertrophy can be simply and successfully treated with Botox injections. In my Indianapolis plastic surgery practice, I usually start out giving 25 units per masseter. This is relatively painless, done with a long 30 gauge needle which is introduced over the most prominent parts of the muscle near the jaw angle. The needle is introduced down to the bone where it is then retracted and injected. This makes sure that the injection is done into the muscle and not into the subcutaneous space. Usually about four or five injections are given per side based on feeling the most prominent parts of the muscle as the patient clenches.
In men and in most Asians, due to their inherently larger muscle mass, the initial injection is higher averaging 35 to 40 units. The injection methods remains the same.
In the masseter, the effects of Botox usually are felt in seven to ten days as one’s clenching and headaches are less noticeable. (if those symptoms existed beforehand) The muscle slimming effects become apparent in two to three months. It is quite surprising that the muscle mass could be reduced in such a short period of time, but I have seen it consistently occur. This improvement in facial shape is clearly evident by frontal photography as the affected sides become less square and more oval-shaped.
How long the effects of Botox last is variable. When it comes to pain relief from bruxism, I find that it lasts about the same length of time as for facial wrinkle relaxation, around four months or so. If aesthetic muscle reduction is the goal, the effects are longer and it is not necessary to re-inject until about six to nine months later.
The interesting questions are ……how long do the muscle slimming effects last once the Botox treatment stops…and are the muscle reducing effects permanent? There are no exact answers to these questions but I would find it hard to believe that maintenance injections are not necessary. I have had no bruxism patients, who over time, had their clenching cycle broken and have had a long time of relief. But I wouldn’t go so far as to say permanent.
Certainly Botox injections are much more appealing than surgical debulking of the masseter muscle or mandibular angle bony reductions. With the recent introduction of a competitive analogue to Botox, Dysport, it will be interesting to see if its effects are longer lasting as purported.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
On this week’s Doc Chat Radio show on WXNT 1430AM in Indianapolis from 1:00 - 2:00PM on Saturday afternoon, hosted by Dr. Barry Eppley Indianapolis plastic surgeon, the popular plastic surgery topic of Botox and Botox injection therapy was discussed. Dr. Eppley interviewed several patients who have had Botox injections for different cosmetic and medical reasons including reduction of forehead and crow’s feet wrinkles, clenching and painful masseter muscle symptoms, migraine headaches, and excessive axillary (armpit) sweating. The history of Botox, its chemistry, and the development and future application of its human uses were reviewed. Patients discussed what Botox injections were like, what happened after, how long did it take to work, how their symptoms were improved, and how long it lasted.
Free Botox and Facial rejuvenation consultations with Dr. Eppley can be arranged by calling his Clarian North office at 317-814-4100 or his Clarian West office at 317-217-2200.
Excessive sweating, also known as primary focal hyperhidrosis (PFH), is a disorder of the sweat glands that may involve the axillae, palms of the hands or soles of the feet. Why the sweat glands produce such high volumes of fluid is not known. This problem affects nearly 3% of the US population and is understandably associated with considerable embarrassment issues. There is also the need for frequent clothing changes which poses physical and occupational problems.
Axillary hyperhidrosis has been treated by a variety of strategies including topical aluminum salts, oral anti-sweating agents, numerous surgical approaches that either cut out and try to remove the sweat galnds, and even nerve sympathectomies. These treatments, however, have never been consistently successful and some have a relatively high incidence of adverse effects and complications.
Botox was approved by the FDA in 2004 for the treatment of axillary hyperhidrosis. It has been shown to considerably reduce armpit sweating without any side effects.The patient considered for axillary Botox treatment had usually had a history of excessive sweating of the axillae for several years that has not responded to aluminum salt-based antiperspirants and requires more than one clothing change per day.
Botox injections are fairly easy to do and relatively painless. Ideally the injection site is first mapped out by the starch test. Iodinated starch power is initially dusted on the surface of the armpit. When this powder contacts sweat, it turns a dark purple which clearly outlines the problem area. While this is the standard approach, I often do not feel that the starch test is absolutely necessary. Most of the excessive sweating areas will come from the hair-bearing part of the armpit. Mapping out the hair zone will usually encompass the sweating zone.
Botox Injections are done with a very small needle and are injected about 1 cm apart which is their approximate diffusion zone. It usually takes about 50 units per armpits or about 12 injections per side. While one could treat just one side to determine dose response, most patients prefer to do both at the same time. Each injection is like a tiny pinprick so it is not particularly uncomfortable. For those concerned about injection pain, the area can first be coated with an anesthetic cream done thirty minutes before the injections.
There usually is little post-injection issues. Sometimes it may be mildly sore for a day or two and an occasional injection bruise may develop. But otherwise one resumes all activities immediately after. It may take up to two weeks after the injections to see the full effect. It is certainly possible that some sweat glands may be missed. These ‘skip’ areas can be re-injected after the two week period when one is certain that they are not the result of a delayed Botox onset.
While Botox is not a permanent cure for axillary hyperhidosis, it can produce some remarkable dryness results that can be life changing. In my Indianapolis plastic surgery practice, I have observed that results can persist for at least six months and may well last longer than a year for many patients.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
The success of Botox for facial expression relaxation has led to many imitators and knock-offs. Since Botox was clinically approved in the U.S. in 2002, many topical products from creams, lotions, and patches have become commercially available that allegedly produce ‘Botox-like’ results. People searching for a less expensive treatment option are lured in by these at-home treatments. While some of them may produce some mild facial relaxation effects, no topical treatment will remotely come close to the effects of Botox injections.
The do-it-yourself (DIY) approach to Botox has now taken a dangerous twist. A pack containing ‘Botox’ powder, needles and a face map has become available without a prescription on eBay in the US for $95. Who exactly was trying to sell this is unknown but eBay has now withdrawn the product offering due to complaints.
This disturbing product attempt to capture the cosmetic bargain seeker and the naive is more than just an all too common internet scam. Botulinum toxin (if in fact that is what it really contained) is a dangerous compound that is widely affected by concentration, how it is mixed, where it is injected, and by how much is injected. It is not like injecting insulin if you are a diabetic, you have to have very specific knowledge of facial anatomy. The effects of botulinum injections depend on getting tiny amounts into exactly the right facial muscle. Get it wrong and you could end up with weakness in your eye muscles and drooping eyelids…or worse you could have more widespread effects such as having difficulty breathing. The recent cases of blackmarket Botox injections in Florida illustrate the worse case scenario.
It is appalling that anyone would attempt to sell a DIY Botox injection kit, offering a procedure that should be done by qualified medical professionals in an in-office setting. While the internet has becomes a marketplace for cut-price cosmetic treatments, you usually have only your money to lose. DIY Botox places much more at risk. This is likely not the last such attempt to make a quick buck on the coat tails of Botox but the old motto is as valid today as it ever has been….if it sounds too good to be true…
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Bruxism is a common orofacial problem, which affects a large number of people all around the world. It presents as chronic teeth clenching, grinding, and temporal headaches. While not yet widely recognized or employed by most dentists, bruxism can be successfully with Botox injections.
I have found Botox to be tremendously effective at masseter muscle hypertrophy and symptomatic teeth clenching. Bruxism or chronic grinding of teeth can cause the jaw muscles to become stronger and achieve a square shape, while simultaneously causing damage to the back premolar and molar teeth.While dental splints and appliances are the standard of care currently, they do not treat the source of the problem (muscle) but rather are primarily protective of ongoing damage to the teeth. Conversely, Botox achieves muscle relaxation or stops muscle spasm which are triggered by the muscles of the jaw.
The part of the masseter muscle that is injected is the lower part which is easy to feel bulging when one clenches. This is in front of the parotid gland and above where the marginal mandibular nerve passes along the lower jawline. It is essentially at the jaw angle area. While other parts of the masseter muscle can be injected, this lower area is the easiest with essentially no risk of any complications. By using a very small 30 gauge long needle and a 1cc syringe, Botox can be near painlessly injected in multiple areas of the bulging muscle.
Many people have a symptomatic facial side, and often that side is visibly larger than the non-or less symptomatic side. In these patients, I will inject only the larger side with about 25 units. When both sides are involved, I will put more on the larger side. On average, it takes about 25 units per side injected into the thickest and most protruding masseter muscle. (when the patient clenches) At a cost of around $12 to $14 per unit, cost estimates per side would be about $350. Botox will not work immediately, on average it takes 3 to 5 days to begin working.
Most patients that I have treated get significant relief with Botox injections. For some, it is a complete ‘cure’ (albeit temporary) and for others it is about reduction in their symptoms. I have yet to see a a patient who gets no relief with an identified large masseter muscle bulging. Pain and clenching relief will last around 4 months which is typical for how long Botox lasts in the face for expression reduction. Interestingly, one will usually see the size of the muscle reduce over time, often within the first treatment cycle. While not fully explained, this muscle shrinking is seen consistently.
How long does one need Botox for clenching symptom relief? That is going to vary per each patient. Some may only need one or two treatments and then the cycle is broken. Others may need consistent treatment every 4 months for a year or two. It is not possible to predict for anyone how long one may need or want this injection therapy.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis
Competitive alternatives to Botox continue to sprout up around the world. The newest one is Azzalure, a botulinum toxin Type A muscle relaxant developed for aesthetic use and manufactured by Paris-based Ipsen. It has just recently received marketing approval in France. The marketing approval is for the temporary improvement in the appearance of moderate to severe glabellar lines in adults up to age 65, when the severity of these lines has significant psychological impact on the patient. The approval was based on several clinical trials involving more than 2,600 patients. This is essentially the exact indications that Botox was FDA-approved for in the United States.
Azzalure will be marketed by Galderma, a dermatology company, in France starting this year. The market authorization for Azzalure follows from a recent approval from 15 European countries’ health authorities in January. Since this announcement, three other market approvals for Azzalure have been granted in the United Kingdom, Denmark and Portugal.
There is no available information as to how Azzalure compares to Botox in terms of duration of action, unit dosage, or cost. It is likely that it is similar in its effectiveness and in how long it lasts, given that it is a Type A botulinum derivative. While Azzalure may have market approval in Europe, do not expect to see it here in the United States any time soon. The transition from European CEA approval to FDA approval can be a long and arduous one. The most likely competitor to Botox to appear perhaps this year is Reloxin. (also known as Dysport in most of the rest of the world) It has been around and used much longer and is well into the FDA regulatory process.
While major cosmetic surgery may be down, noninvasive treatments such as Botox, continue to hold steady and may even be increasing despite the economy. Because of their effectiveness, relatively low cost compared to surgery, and no need for any recovery, Botox and injectable fillers offer a quick fix for minor to moderate facial rejuvenation.
Dr. Barry Eppley
http://www.eppleyplasticsurgery.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis