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Posts Tagged ‘dysport’

Comparing Botox, Dysport and Xeomin Injectable Facial Neuromuscular Modulators

Sunday, April 20th, 2014

 

The announcement this month that Johnson & Johnson (J & J) has pulled any further development of their aesthetic neuromuscular modulator PurTox was a surprise. It was certain several years ago that a fourth injectable drug would soon be on the market to compete with the big three, Botox, Dysport and Xeomin. But it now appears that these three cosmetic drugs will only have only to compete amongst themselves for some time into the foreseeable future.

Botox Facial Wrinkle Injections Dr Barry Eppley IndianapolisIt has now been three years since the last of the big three (Xeomin) was approved. And while there has been some minor new FDA approvals for indications that were already widely done off-label anyway (crow’s feet), the number of men and women seeking this injectable cosmetic treatment continues to grow. Having multiple products to treat unwanted facial lines and wrinkles has helped create awareness and grow the market. These drugs today are as accepted as capuccinos and are done almost just as much. To some degree, Botox and his competitors have very much become commodities where the lowest cost per unit often sways what provider/location that a patient will go to.

This raises the question of how do these drugs differ and, what advantages if any, do any of them offer over the others? What all three drugs share is that they are FDA-approved Type A botulinum toxins. They work exactly the same through the same mechanism of molecular action and all have the same type of heavy chain receptor. While Dysport and Xeomin have a little shorter onset (1 to 2 days), they last the same amount of time as Botox having a duration of action of between 3 and 4 months after injection.

Dysport Indianapolis Dr Barry EppleyThey do differ significantly, however, in their dosing and methods of storage. The dosing of Dysport is very different from that of Botox or Xeomin. This makes it difficult to compare Dysport to the other two in clinical studies. While the biologic activity is the same for Botox and Xeomin, it is quite different for Dysport and there is no standard dose conversion. While all three must be reconstituted on the day of administration, Xeomin does not require refrigeration which makes it more portable and not prone to be accidentally left out of cold storage after a treatment.

From a marketing and public awareness standpoint, Botox is the dominant force occupying close to 80% of the market. It is the ‘Coke’ of the injectable neuromuscular modulators, the most studied and also the most expensive. Dysport and Xeomin are the ‘Pepsi’ and ‘Seven-Up’ by comparison and are still trying to gain market share. As a result they are priced under that of Botox and is there only real method of improving their small market share given that they have no other advantages.

Xeomin Indianapolis Dr Barry Eppley IndianapolisSome small claimed advantages over Botox for Dysport is that it has wider zone of diffusion from the injection site. This may be an advantage in the bigger muscles areas of the frontalis muscle of the forehead and the orbicularis muscle of the crow’s feet area. But would be a disadvantage in a discrete muscular area like the glabella which is also the number one area for all aesthetic neuromuscular injections. Xeomin claims a less risk of allergic reaction than with Botox because it does not contain hemagglutin and non-hemagglutin complexing proteins. While this may be theoretically true, the incidence of allergic reactions to Botox is so insignificant after over twenty years of clinical use that this advantage is meaningless.

While there are other aesthetic injectable neuromuscular drugs under development, none of them seem to have any major advantages over the big three that are available now. Every patient would like them to last longer (or be permanent) and cost less but that does not appear to be likely for as far as one can see into the future. The one promising approach is that of a topical botulinum type A gel of which several companies have ongoing clinical trials. Avoiding needle sticks could be the one advantage a new product could have that would help shakeup the market as we know it now.

Dr. Barry Eppley

Indianapolis, Indiana

Plastic Surgery Product Review: Xeomin Injectable Facial Wrinkle Reducer

Monday, November 28th, 2011

The battle of the facial wrinkle reducers continues to become more competitive. Botox has always been the gold standard because it was first and largely established the market as it exists today. Several years ago Dysport entered the scene which initially caused a bit of buzz. But to date it has not eroded dramatically Botox’ dominance in the aesthetic facial market. This is mainly because Dysport does not offer any significant differences in its effects to either the doctor or the patient. With a minimal price difference, it is perhaps no surprise that Dysport has not offered up a real challenge to Botox as of yet.

More recently a third player entered the facial wrinkle reducer market known as Xeomin. Like Botox and Dysport, it is a form of botulinum toxin known as incobotulinum toxin A. It has similar muscle paralyzing effects and is approved like the other two based on the predicate treatment site of the frown lines or ‘11s’. It is already FDA approved and used in adults for cervical dystonia and eye twitching. It is manufactured by Merz Pharmaceuticals who also has the aesthetic products of Radiesse filler and Asclera sclerotherapy agents.

While it is a competitive analogue, what makes Xeomin different if anything from Botox and Dysport? The most obvious difference is that it does not need to be refrigerated. This may seem like a trivial difference that only matters to the doctor, but it has great relevance to the patient as well. If Botox or Dysport is mixed and accidentally not refrigerated, it becomes ineffective quite quickly. If someone has ever had a facial injection and it did not work, it may have been caused by  a ‘bad’ drug mixture that was allowed to get warm or had been forgotten to be refrigerated overnite. This is also a benefit in the way the drug is distributed and shipped from the manufacturer. The other minor difference is that Xeomin  is manufactured without additives. This may lessen the potential for any drug reaction problems.

Otherwise, Xeomin is report to be more similar to Botox than Dysport. This is said from the perspective that it takes about one week for the full effects of the drug to be seen. Only Dysport has a faster onset. Otherwise, all of them have the same duration of effect of around four months. The cost of Xeomin is as of yet unknown but I suspect it will not be substantially less in cost than Botox. This will place the treatment of the glabellar furrows (11s) around $350 to $500.

Where will Xeomin fit into the injectable facial wrinkle market? Without a substantial performance difference or cost benefit, it will likely end up similar to the fate of Dysport so far. Occupying a small percent of the market and, like Dysport, being the Pepsi compared to Coke.  

Dr. Barry Eppley

Indianapolis, Indiana

The Evolving Role Of Neurotoxins for Aesthetic Facial Improvements

Wednesday, November 9th, 2011

Aesthetic neuromuscular modulators, known more commonly as Botox, Dysport and now Xeomin, has been a decades old concept from an FDA standpoint….and twice that long as an off-label use for the treatment of unwanted facial expressions and wrinkles. Because the dose of each of these injectates will vary between each patient, it has become clear that their use is as much art as it is a science. While manuals exist as guidelines for where to inject and doses to use, each patient must still be treated individually.

The dosing issue has become more complicated now that there is more than just Botox available. Most physicians feel that there is a 3:1 unit comparison between Dysport and Botox and the jury is still out on where Xeomin will compare. I generally use 24 to 30 unitsof Botox for the glabella, frontalis and crow’s feet areas, the most common area for neurotoxin use. This works well for most patients and is a good value point for a cosmetic treatment that will last around four months. By comparison, the comparative dose of Dysport would be 70 to 90 units for the same areas.

There remains some controversy about whether Botox or Dysport is ‘better’. There is tremendous brand loyalty amongst providers to Botox and the company certainly does a lot of marketing and promotions to maintain it. I think Dysport has done a relatively poor job of how it markets and promotes its equivalent and, as a result, it continues to be occupy a relatively small piece of the injectable neurotoxin market in the United States. Whether that will change depends ultimately on how well it works in the years ahead.

It appears fairly clear that Dysport does have a few days of earlier onset and a greater zone of diffusion than Botox. This makes it preferable to those who want to have a quick onset of action and may be better in the crow’s feet area where the orbicularis muscles are broad. Because of this greater diffusion, some feel that it has a higher risk of unintended effect in areas where numerous muscles have opposing actions such as around the mouth. I have heard and read that Dysport lasts longer and is more cost-effective but these claims are not substantiated by any clinical study.

Unlike ten years ago, the one area that Botox and its competitive analogues have had increasing use is as an adjunct and sometimes a replacement for surgery. For many patients, reducing muscle action in the forehead can delay or eliminate the need for a surgical browlift. While this so-called chemical or pharmacologic browlift is very useful in the forehead, it is ineffective for the mid- or lower face as a lifting technique. For those patients actually undergoing a browlift, injecting Botox either before or after the procedure can enhance the results. I find it particularly useful in my Indianapolis browlift patients for injecting during surgery to get the best lift possible in the tail of the eyebrow. This is an area that can be the most difficult to surgically lift as opposed to the central brow.

Another area that injectable neuromuscular modulators are very helpful is in laser skin resurfacing. By injecting at least a week before surgery, the muscles are relaxed so there is not as much pull on the healing skin as it is healing. That does provide some better comfort although touting it as promoting better healing is not based on any science. A good protocol that I use is to inject Botox two weeks prior to laser resurfacing and then again at three or four months afterwards to maintain a good smooth result. Keeping the muscles relaxed will also prolong the results of many non-surgical treatments besides laser resurfacing such asinjectable fillers, chemical peels, and skin tightening devices. (Skin Tyte, Thermage, Ulthera, Exilis)

Dr. Barry Eppley

Indianapolis, Indiana

The Influence of Botox on Emotional Expressions

Tuesday, August 17th, 2010

Any drug that can change facial expressions can certainly influence how other people see and interpret you. But can they also change how you feel as well?

In the June 2010 issue of Emotions, researchers out of New York published a paper which reported that people who were treated Botox treatments not only change their appearance but may also had a weakened ability to experience emotions.

The facial feedback hypothesis (FFH) in psychology has long purported that if an emotion can not be expressed physically then it really doesn’t exist. It has remained largely an unproven theory as it is difficult to isolate an emotion as a physical loci. But the widespread use of Botox, a muscle weakening agent used for cosmetic wrinkle reduction, can suppress emotion by its effect on facial muscle units. This now makes it possible to work with people who have a chemically-induced expressive muscle weakness.

As a result, the theory of FFH can be tested for the first time. A person who has received treatment with Botox can still respond to an emotional event (something that makes them angry) but their facial muscles will be less active. Less muscle stimulation to the brain results with less feedback to the brain about what the face is expressing. This allows for a test of whether facial expressions and the feedback to the brain that it creates can influence our emotions.

The reported study used two groups of patients, one who got Botox injections and a control group which received a cosmetic filler (Restylane) which does not affect the facial muscles. Such a study design allows one to isolate the effects of facial expression and the subsequent sensory feedback to the brain that would follow from other factors, such as intentions relating to one’s expressions and motor commands to make an expression. In the study, the subjects filled out questionnaires about how they felt after watching positive and negative video clips before and after treatment.

The findings of the study shows that those who received Botox had no changes between the pre- and post-treatment emotional responses to the most positive and negative video clips. But, compared to the control filler group, Botox patients had much lower strengths of emotional responses. Their conclusions were that feedback from facial expressions is not necessary to have an emotional experience, but it may modify the intensity of that emotional experience.

Considering the number one reason people have Botox is to decrease the frowning or scowling between their eyebrows, this may also help people feel less angry and irritated. So maybe Botox, and its cousins Dysport and Xeomin, really are tranquility drugs as well.

Dr. Barry Eppley

Indianapolis, Indiana

Xeomin Botulinum Injections – An Alternative to Botox and Dysport

Tuesday, August 10th, 2010

Botox continues to be one of the top non-surgical (really minimally invasive) cosmetic procedures. In combination with injectable fillers, a whole new area of cosmetic improvements has been made possible. While Botox dominated the cosmetic neuromuscular market for almost a decade, its success was certain to lead to competition. Such was the case in the summer of 2009 when Dysport received FDA approval in the United States for cosmetic applications. Now we have both Botox and Dysport available although the battle is shaping up to be more like Coke and Pepsi. It is likely that Botox will dominate the market for the foreseeable future until…a competitor comes along that offers a neuromuscular product which is either substantially cheaper or lasts longer.

Interestingly, last week Merz Pharmaceuticals announced that it has received FDA approval for its botulinum toxin product,  Xeomin. (technically incobotulinum toxin A) It is only currently approved for the treatment of adults with blepharospasm or cervical dystonia. To some, those applications may seem obscure but that is exactly what Botox was initially approved for way back in the 1990s. While this drug is not yet approved for cosmetic facial use, there is no doubt that is in the manufacturer’s plan in the future as soon as possible.

The results from the reported clinical trials for the use of Xeomin were in adult patients diagnosed with either cervical dystonia or blepharospasm.  Other comparison studies with Botox showed that it had a similar effectiveness and side effect profile for these applications.

Like Botox, Xeomin is an injection that blocks the transmission of nerve pulses into the muscle. But it appears to have some pharmacological differences. It is reported to have increased biological activity which may or may not mean that it is more effective at lower doses.  It has less ancillary proteins, so it is more pure, and thus may be less prone to develop drug resistance.The drug also does not need to be refrigerated unlike Botox and Dysport. That is only a minor benefit to the injector but a major one to the manufacturer due to shipping issues.

The key questions as they relate cosmetic use is how does Xeomin compare to Botox and Dysport in effectiveness and cost. While no clinical studies have yet been reported, every indication is that the onset of the effects is the same (one week) and its length of action is similar. (3 to 6 months) Its cost is not presently known so the idea that it may be less expensive is theoretical and likely over optimistic.

Early evidence suggests that Xeomin is going down the Dysport road…an alternative to Botox without appreciable upfront differences to the consumer. While it is not FDA-approved for cosmetic use, it will no doubt be used off-label long before it ever receives that blessing.

The manufacturer, Merz, is adopting a market strategy similar to its competitors. It has acquired Bioform Medical, the manufacturer of the injectable facial filler Radiesse. As a company it is key to have a dual cosmetic injection approach, a neuromuscular paralyzer and a volume filler. Merz appears poised to make its entrance into the cosmetic marketplace.

Dr. Barry Eppley

Indianapolis, Indiana

The Effect of Botox on the Masseter Muscles

Wednesday, June 2nd, 2010

The masseter muscle is a very large and thick muscle that occupies the outside of the  mandible back by the angle of the jaw. It is one of the major muscles responsible for moving the jaw. Because of where it is located, it can contribute significantly to fullness of the lower face. When it is enlarged or naturally larger (as in some ethnic groups), it can be extraordinarily obvious and contribute to a more square facial shape.

Reduction of a large masseter muscle has historically been difficult. Surgical reduction is possible but it is associated with a significant amount of swelling and a long recovery period. Restricted oral opening and persistent trismus make a subtotal myectomy of the masseter very unappealing.

Botulinum toxin type A, Botox or Dysport, has been used off-label for masseter muscle treatment for some time. Anectodal reports abound that it is effective for visible muscle reduction with repeated injections. In my Indianapolis plastic surgery experience, I use it regularly and my observations is that it does work by visible and photographic assessments. Numerous clinical reports have also been published that support its effectiveness which date back to as early as 2001. The question is not whether it works but are its effects sustained? Must the injections be continued forever or is there a point where the injections are not needed to sustain the effect?

In the June 2010 issue of the journal Plastic and Reconstructive Surgery, these very questions were addressed. A published study retrospectively 121 patients who were treated for more than one year with botulinum injections (Dysport) into the masseter muscles. (100u to 140 u per side) The patient’s masseter muscle thickness was measured by ultrasonography. The patients received variable numbers of injections from two to eight. Overall masseter muscle size was reduced from roughly 13.5 to just under 10 mms. With increasing number of injections came further muscle thickness reduction.

This study shows that sustained effect of masseter muscle reduction can be obtained by repeated muscle paralyzing injections. Because the sample size is inconsistent with irregular visit intervals and injection periods as well as patient ages and muscle thicknesses, no firm dose or injection interval could be specifically recommended. One interesting graph shown in the paper demonstrates a predictive relationship of the maximal effect and the sustained effect. This graph suggests that three injection sessions during the first year leads to a sustained muscle reduction effect. This sustained amount of muscle reduction is not as great as that seen in the first few months (maximum effect) but could be maintained out to greater than 36 months after the first year’s injections.

One of the interesting questions is why would masseter muscles shrink or reduce in size if the same thing is not seen with the muscles of facial expression? If botulinum toxins can reduce muscle volume, why do not wrinkle treatments need less toxin dose and are maintained longer with repeated injections? One very plausible explanation is that the type of muscle fibers are quite different. Muscles of facial expressions are faster twitch fibers and are structurally different than that of the master muscles. All facial muscles are not created equal. Another difference in the sustained effects between the two muscles is in how they recover. The assessment of facial expression muscle activity is when they start working again, The assessment of masseter muscle recovery from injection therapy is a change in size which is quite slower, thus the longer effect than that seen in wrinkle treatments.     

Dr. Barry Eppley

Indianapolis, Indiana

Botox as a Treatment for Excessive Forehead Sweating

Sunday, April 25th, 2010

Botox is most well known for reducing facial expression activity and the wrinkles that they cause. Less known, but no less appreciated, is its use for excessive sweating or hyperhidrosis. This is another FDA-approved indication for Botox use. For those afflicted with excessive armpit or axillary hyperhidrosis, the relief from the constant wetting and staining of shorts and the embarrassment that it can cause is significant. For reasons not completely understood, the duration of action of Botox for hyperhidrosis is considerably longer than its effect on diminishing facial muscle movement.

Any type of excessive sweating not even as well recognized as axillary hyperhidrosis is what is known as craniofacial or scalp and forehead hyperhidrosis. This is excessive sweating of the scalp and forehead mainly. Patients report symptoms such as sweat pouring from their forehead while just sitting or beads of sweat that form and run down with nonstrenuous activities. From a diagnosis standpoint, it can be difficult to differentiate between heavy sweating from heat or exercise and true hyperhidrosis of the face or scalp. But if the sweating, regardless of the reason, is bothersome then treatment options should be considered.While the traditional  approach to any type of hyperhidrosis are topical solutions, these are problematic above the neck. Strong antiperspirant products can be irritating to the skin of the face, head, or scalp (can be impossible to apply due to hair) and are usually not  a good solution. Prescription medications, such as anticholinergics, can also be used but they have definite side effects including dry mouth, blurry vision, and constipation.

Like its use in the axilla, Botox can be very effective for excessive scalp and forehead sweating. Injection technique is critical and should not be confused with how it is placed for forehead and glabellar wrinkles. The injection should be placed just under the skin and not deeper into the muscle or galea. If Botox is injected deeper in the muscle or too close to it, diffusion may occur causing some forehead asymmetry. This is a very minor problem and can easily be balanced out with additional Botox injections. If the injections are well placed and symmetric, however, any effect on the frontalis muscle will be balanced and not problematic.

Given the limited zone of diffusion for Botox (1 cm. or less), the location of the injections is critical. I have found that the best location is along the hairline from one temporal area to the other. Since most excessive scalp and forehead sweating is in men, one should use the original hairline whether hair still exists there or not. There is always a pretty clear demarcation between the original scalp and the non-hair bearing forehead. Spacing 4 unit injections about 2.5 cms apart, the usual starting dose is 32 units. That can be adjusted to higher dosing dependent on the degree of response or residual sweating zones. 
For those bothered by excessive and embarrassing forehead and scalp sweating, Botox injections can offer a significant and sustained improvements. Reduction or elimination of the sweating lasts for at least six months or longer. The newer Dysport botulinum injection should be presumed to have similar success.

Dr. Barry Eppley

Indianapolis, Indiana

Glabellar Lines and Wrinkles – Botox Injections vs. Browlift Surgery

Tuesday, February 2nd, 2010

One of the typical features of an aging upper face are a variety of skin lines that develop between the eyebrows. The action of specific muscles combined with the effects of gravity create an abnormal skin pattern of vertical, oblique, and horizontal lines. These dynamic and eventual static wrinkles are bothersome for many patients as they create the emotional impressions of anger, grief, and age.

The non-surgical use of Botox injections and the surgical approach of browlifting or foreheadplasty are proven methods of modifying these muscles. By changing the degree or amount that these muscles move, the upper face becomes more relaxed and more youthful.

The corrugator muscle is the main culprit in this indesireable set of glabellar facial expressions. The horizontal portion of this muscle is responsible for pulling the eyebrows inward. When done enough over time, an evident pair of vertical skin creases develop. Known as the ‘11s’, they may also infrequently appear as a single large vertical crease. These vertical lines always extend significantly above the height of the eyebrows.

The oblique glabellar skin lines occur just at the level of the eyebrows, are oriented obliquely, and careful inspection will reveal they are not part of the vertical skin lines. They are caused by the medial eyebrow depressors which consist of the oblique head of the corrugators, the depressor supercilii, and the medial fibers of  the orbicularis oculi muscles.

The skin crease that sits below the eyebrows is horizontal and is often called the ‘bunny line’. It is caused by the procerus muscle which pulls down the inner eyebrows. It creates this crease as it pushes down against the  more fixed skin of the nose.

The combination of these six muscles flexing over time etches this pattern of glabellar lines between the eyebrows. In essence, dynamic wrinkles eventually become static lines if unchecked. This makes a good argument as to the benefit of early use of Botox or Dysport when one first begins to see this skin pattern appears. Such chemical prophylaxis is effective and many younger women today are embarking on this approach.

In established and deeper glabellar wrinkles, Botox and Dysport injections will make them more shallow but will not make them go completely away. In some cases, injectable fillers must be combined with muscle relaxation injections to make for a nearly complete smooth and wrinkle-free area between the eyebrows.

If one is seeking a more permanent or longer-term treatment, this is where the option of a surgical foreheadplasty comes in. Besides altering the shape and position of the eyebrows, this operation is intended to help lessen these unfavorable glabellar skin lines. This is done by weakening the actions of the aforementioned six muscles through removal or excision of some of these muscles. This is best done through an open incision (coronal or hairline browlift) but good and diligent endoscopic techniques can make a dent in their action also.

Most patients, regardless of their degree of glabellar skin lines, begins with injection therapy to see how much improvement they can achieve. In advanced cases associated with excess upper eyelid skin, the combination of a browlift and blepharoplasty can make for a satisfying forehead result.     

Barry L. Eppley, M.D., D.M.D.

Indianapolis, Indiana

Common Questions about Botox and Dysport Injections

Sunday, January 3rd, 2010

1.      How soon will I see the results of my Botox treatment? And how long will it last?

 

Unlike injectable fillers, the effects of Botox are not seen immediately. It takes several days for Botox to begin to ‘kick-in’and a full week for its maximal muscle-weakening effects to be seen. Clinical studies show that the average length of time that Botox works is between 100 to 130 days. (three to four months)

 

2.      What is the difference between Botox and Dysport injections?

 

Botox was FDA approved for cosmetic use in 2002 and was the only injectable facial wrinkle reducer until recently. In the summer of 2009, Dysport became available as a competitive drug to Botox by a different manufacturer. It s a botulinum toxin with a slightly different molecular structure . While Dysport was released with much hype about its potential for lasting longer and being less expensive, my experience in my Indianapolis plastic surgery practice shows that much about it is comparable to Botox. If Dysport has any advantages over Botox, they are not yet apparent.

 

3.      Will my face be frozen afterwards? Will I look unnatural?

 

A common patient concern and misconception about Botox is that one’s face will look unnatural afterwards…and be like some Hollywood faces. While this can certainly be achieved with Botox, it takes a lot of injections (high doses) and cost to create this unnatural look. And this is usually beyond the budget and desires of most patients. Judicious use of Botox in a few select facial areas produces a relaxed and natural facial look. Botox is primarily used to reduce furrowing betweens the eyebrows, lessen horizontal forehead wrinkles, and make wrinkles around the eyes less noticeable.

 

4.      Does the regular use of Botox keep my wrinkles from getting deeper and keep me looking young?

 

Because Botox temporarily reduces wrinkling caused by continuous facial muscle activity, its regular use has long-term anti-aging facial benefits. Regular Botox use over years does result in less facial wrinkles because the cause of them has been reduced. I have seen this particularly illustrated in a set of identical twins where one has had Botox for over seven years and the other has not. The amount of facial wrinkles is significantly reduced in the Botox user.

 

5.      Are Botox treatments the same no matter where I go?

 

In theory, the results of Botox injections should be the same no matter where you go. But there are a variety of factors that affect how well Botox works and what results are obtained. Injector experience, how Botox is prepared, where on the face injections are given, and how many units are administered all affect what results are seen.

 

6.      Can one become immune to the effects of Botox?

 

Developing a resistance to a drug is always possible. Most patients never develop a tolerance or an immunity, but reported cases do exist. A minority of treated patients will develop a perception that Botox isn’t working as well as it used to. Whether this is because one has become accustomed to the results or whether it really is less effective is not clear. In these cases, one may try Dysport instead which has a slightly different formulation to which the body may be more susceptible.

 

7.      What other cosmetic and medical conditions is Botox useful?

 

Botox has been around for over twenty years and has a variety of approved uses. Most of these are for muscular conditions such as spasms in cases of paralysis and for strabismus. (continuous eye muscle twitching) Botox has been approved during this past decade for hyperhidrosis (excessive sweating) of the armpits, hands, and feet. Encouraging results are being seen in off-label applications of the face such as in the treatment of certain migraine headaches and TMJ and jaw muscle disorders.

Dr. Barry Eppley

Indianapolis, Indiana 

 

 

 

 

Dysport Clinical Study – Is It Better than Botox?

Monday, November 16th, 2009

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 the journal Plastic and Reconstructive Surgery, the results from a clinical trial that evaluated the effectiveness of Dysport for glabellar lines was published. 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

Indianapolis, Indiana

 

  

 


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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