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Aesthetic Physician Bulletin: DIY & Illegally Imported Botox

The IAPAM has surveyed experts in the cosmetic injectable field to offer this overview for aesthetic physicians, regarding some alarming and illegal trends dealing with cosmetic injectable treatments, specifically: DIY (Do It Yourself) Botox treatments and illegally imported botulinum toxin (Dysport, Botox) product. Without a doubt, proper Botox Training is critical.

The Recent DIY Botox Trend

Recently, there have been several reports regarding DIY “botox-like” injectables, which can be purchased through the internet. A woman in Texas, Laurie D’Alleva, offered consumers a botox-like product called “Freeze,” complete with a “How-To” video, so consumers could administer the botulinum toxin themselves.  “The Texas Attorney General is charging D’Alleva with several violations of state law.  She could be fined up to $25,000 per violation per day of the Texas Food, Drug and Cosmetics Act, and up to $20,000 per violation of the Texas Deceptive Trade Practices act.”  The red-flags regarding this internet offering range from the unrealistically low pricing, indicating the product is not FDA approved, to her complete disregard for the potential life threatening side affects that can accompany the delivery of a neurotoxin into the body by an untrained, unlicensed administrator.  Read more

               

Topical toxin appears to be promising in phase II data

NEW YORK – A topical, noninjectable form of botulinum toxin asserted its ability to effectively treat crow’s feet through impressive data from a recently completed phase II clinical trial released here.
 
Seventy-five patients at four study sites were treated with the novel topical toxin or placebo to the crow’s feet area. On a four-point static scale, a significant number of participants showed two point moves, according to Michael Kane, M.D., a principal investigator in the trial who released aggregate data from the study at the American Society for Aesthetic Plastic Surgery annual meeting.

“As one of the study centers, I was not unblinded as to which of my patients had toxin and which were [treated with] placebo. But, clearly, by looking at the patients, there were those whose crow’s feet got a lot better and some whose didn’t,” Dr. Kane, a plastic surgeon in private practice in New York City, tells Cosmetic Surgery Times. “The difference was night and day, both at rest and smiling. The people who showed significant difference, unsurprisingly, had lateral brow elevation, as well. Obviously, the toxin was working on the muscle.”

TRANSDUCTION TRANSFORMATION

The concept of simply applying a topical to eliminate wrinkles is not new, but proving the theory has yet to be conclusively accomplished. Yet, researchers involved with the development of the topical form of botulinum toxin think they are close. Its developers at Revance Therapeutics, Inc., a privately held company based in Mountain View, Calif., claim that the topical allows large macromolecules to cross the skin and other barrier membranes enabling local, targeted delivery. Delivered through the firm’s proprietary TransMTS™ (Macromolecule Transport Technology), the neurotoxin is based on a single, straight-chain, peptide that allows skin to be a gateway for drug delivery, rather than a barrier.

“Adding a peptide as a separate component within the [toxin] formulation allows the toxin to cross the skin,” explains Jacob Waugh, M.D., co-founder & chief scientific officer, Revance. “The peptide forms an ionic bond with the toxin and the peptide also has a Protein Transduction Domain (PTD), which is responsible for transcutaneous flux. It is essentially a quite broad and powerful transduction.”
 
Although the topical toxin’s technology is fairly obscure and complex, the use of two pathways on both the dead and living layers of the skin allows for a significant result, according to Dr. Waugh. Currently, there have been 600 crow’s feet areas treated via the TransMTS™ technology, with a fairly low local irritation rate and no evidence of adjacent paralysis above placebo grade, say the developers.

“TransMTS technology relies on the fluidity of the dead skin, that essentially is the equivalency of the typical topical that loads the stratum corneum, but more interesting is the second pathway that [also] happens on the living cells,” Dr. Waugh details.

“Basically, it’s a variation the cell uses to take a drink, then it dumps the drink back out on the other side of the cell.”

The key to TransMTS technology, say its developers, is a protein carrier featuring protein transduction domains that hold on to the cell membrane and allow larger molecules to pass through it undisturbed. The transport technology is also currently being studied for early applications of new cardiovascular disease drugs. Additionally, three different cancer drug trials are being investigated based on the system’s ability to transport molecules, according to the firm.

ADVANTAGE: EYE

While TransMTS technology may benefit additional medical innovations including insulin and other compounds, a phase III trial is underway to establish the neurotoxin adjunct’s effectiveness and advantages when treating crow’s feet. An area greatly sensitive to injections, a topical toxin may be a relief to most patients.

“I don’t think there’s much question regarding [the topical toxin’s] clinical effect for lateral crow’s feet,” says Richard Glogau, M.D., clinical professor of dermatology at the University of California and participant in the phase II clinical trial. “Yet, they [will need to] keep continuing to improve the formulation due to a delivery problem with the gel vehicle,” he adds.

The gel that allows the combination of the peptide and the toxin to get through the skin and the mechanics of using the gel present challenges in terms of getting it to stay where it is applied, according to Dr. Glogau, who completed a recent study for primary axillary hyperhidrosis with the topical form of botulinum toxin type A.
 
In that study, researchers used the topical agent to treat 12 patients in a randomized, blinded, vehicle-controlled study that also showed promising results: A 65 percent mean reduction of sweating on 10 axillae treated with the BTX-A (200 U) was observed after four weeks of treatment, compared with a 25 percent mean reduction in sweating on the vehicle controlled axillae. Although the topical toxin displayed its ability to reach the bottom of the dermis when treating hyperhidrosis, the one-time dosage upon which the crow’s feet trials’ results are based may be problematic says one investigator.

“It’s a very artificial situation, and I think that anything in dermatology ends up being a serial treatment — patients are looking for long-term effect,” Dr. Glogau says. “Yet, I think the neurotoxin is realistic in its abilities.”

“My one concern is that the topical toxin will be thought of as just the same as an injectable toxin, but in reality it’s another tool,” Dr. Waugh says. “Yet, it can be used to do some of the things that injectables can’t do.”

REFERENCE

Glogau RG. Topically applied botulinum toxin type A for the treatment of primary axillary hyperhidrosis: results of a randomized, blinded, vehicle-controlled study. Dermatol Surg. 2007;33(1 Spec No.):S76-S80.

DISCLOSURE

Dr. Kane is a paid consultant to Revance Therapeutics with an ownership equity interest comprising stock options whose value is less than $50,000 during the time of the study and for one year following completion of the study. Dr. Kane does not have a proprietary or financial interest in a product, patent, trademark, copyright, or licensing agreement, and has not received significant payments from Revance exclusive of the costs of conducting the clinical study or any financial arrangements whereby the value of the compensation could be influenced by the outcome of the study or tied to sales of the product.

Aug 1, 2009
By:  Beth Kapes
Cosmetic Surgery Times

               

New Type Of Botulinum Toxin, Reloxin, Appears To Be Well Tolerated And May Help Reduce Forehead Wrinkles

Injections with a new type of botulinum toxin appears to be well tolerated and may help to improve the appearance of moderate to severe forehead lines with no evidence of diminishing treatment response over 13 months, according to a new report.

Injecting low doses of Clostridium botulinum toxin type A is a generally accepted method for treating lines on the face, according to background information in the article. A new botulinum toxin type A (Reloxin) has been used to treat neurological disorders outside the United States for more than 15 years and is approved to treat wrinkles in 23 countries. In the United States, this product has been under investigation for the treatment of glabellar or forehead lines since 2002, according to the authors. Read more

               

Botox for dudes: No longer a secret shame

The buzz about metrosexuals may have died down, but men’s desire to look good certainly hasn’t. These days, many are turning to Botox to smooth out frown lines and forehead creases.

IAPAM member, Dr. Michael Stanford, co-owner of Embrace Spa in St. Petersburg, said the percentage of his Botox clients who are men has grown from just a handful five years ago to about 10 percent. Reasons range from a greater acceptance of the procedure to a high divorce rate, which thrusts men back into the dating scene, he says. Younger guys do it for prevention. Read more

               

Allergan says Botox works on chronic migraines

CHICAGO (Reuters) - Allergan Inc said on Thursday that its popular Botox wrinkle-smoother worked as a treatment for adults suffering from chronic migraines, according to late-stage clinical data.

Shares of Allergan rose nearly 13 percent as the broad market stumbled.

Botox, or botulinum toxin type A, is the first therapy being investigated for chronic migraine, which affects an estimated 1.2 million to 3.6 million people in the United States, according to the company. Read more

               

Researchers Announce Botulinum Toxin-Based Face Cream

Researchers at the University of Massachusetts Lowell Nanomanufacturing Center have developed a skin cream based in part on botulinium toxin, which, according to the patent application recently submitted to the US government, could be administered topically or as a transdermal patch. Read more

               

Botox Without Borders

Storefronts that provide medical procedures—like Botox—are not necessarily unsafe. However, the best results might come to those who ask the right questions and do their homework.

Easy and convenient food? OK. Easy and convenient Botox? Maybe not. The trend of the “medical spa” has taken shape and can be found at a mall near you. In a spa-like setting, patrons can often receive chemical peels, laser hair removal, or even Botox Cosmetic, the temporary wrinkle-fighting injection. Topping out at about 4.6 million procedures, Botox was the number one minimally invasive cosmetic procedure in 2007, according to the American Society of Plastic Surgeons. The phenomenon of walk-in or storefront centers may go hand-in-hand with the popularity of the wrinkle-fighting procedure. While these new settings are not necessarily unsafe, you need to be aware and do your homework. Read more

               

OC Dermatologist reprimanded for using non-FDA approved Botulinum Toxin

A Huntington Beach dermatologist, received a reprimand for administering a wrinkle-treatment that was not approved by the Food and Drug Administration. According to board documents, Dr. Joseph Manzini administered an experimental Botulinum Toxin to 10 patients. Last year, Manzini pled guilty to an interstate commerce violation and was sentenced to two years probation. Read more

               

IAPAM Launches Aesthetic Medicine News Site

The International Association for Physicians in Aesthetic Medicine (IAPAM) AestheticMedicineNews.com website educates physicians, medical spa owners, media and the public on the latest aesthetic medical news and medical spa procedures.

Las Vegas, Nevada (PRWEB) July 9, 2008 — With the current boom for minimally invasive anti-aging treatments, the first person many people go to is their physician. Moreover, between new State regulations and the need for industry-leading clinical education, practitioners agree that more timely and accessible information is required. Therefore, to meet this industry need, the IAPAM has launched The Aesthetic Medicine News, a one-stop web portal where medspa practitioners and patients alike can find the latest in aesthetic medicine innovations, medical spa news and much, much more. Read more

               

Cosmetic procedure can reveal the youth within

Out, out, damned age spot.

Begone satanic sags, fleshy jowls and jiggly wattles.

If there’s one thing baby boomers hate to see when we look in the mirror it’s a face (or body) that does not match our inner image of ourselves. Read more

               

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