Reloxin approved by FDA, available in 30 to 60 days

Via Bloomberg:

"The Scottsdale, Arizona-based company plans to start selling the drug for aesthetic uses in the U.S. within 30 to 60 days. Approval will trigger a $75 million payment to Ipsen, which developed the drug. The Boulogne Billancourt, France-based company said it will handle sales for cervical dystonia, beginning in the second half of this year.

Dysport may be priced 15 percent lower than Botox, helping it take almost a third of the cosmetic market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Dysport for aesthetic uses will be $160 million by 2012."

BNET is reporting that Allergan is scrambling with seminars emphasizing that Botox and Reloxin are not interchangeable.

Disclaimer: I am on the Reloxin advisory board.

We'll let you know when Reloxin is available in Boca Raton and in New York and New Jersey!

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Guest Blogger: Dr. Mitchell Matez of Sanctuary in Boca Raton on Stem Cells and Anti-Aging Medicine

Recently Drs. Haimes, Pozner, and I attended the International conference of the American Academy of Anti-Aging Medicine (A4M) in Orlando. The conference represents the largest gathering and most extensive educational resource for Anti-Aging Physicians and health care providers worldwide.

Many new and exciting things are on the horizon in the realm of age management. One area that we are watching very closely and remaining well informed on is stem cell therapy. Currently we are offering state-of-the-art stem cell banking here at SMAC Boca. This is a simple process that can store your own stem cells for future use.

The most interesting observation that I have made as I have traveled to these conferences over the years is the amazing synergy and ever expanding relationship between cosmetic and anti-aging medicine. I am more convinced than ever that the “Look good – Feel good” approach that we have taken in opening SMAC –Boca is the best way to ensure ongoing physical and mental health well into our “twilight” years. We will continue to remain abreast of all that is happening in these very exciting areas so that we can continue to provide you with the best care possible.

Dr. Mitchell Matez
Sanctuary Medical Aesthetic Center

Viagra cream for cellulite?

You'd think the media would have been shouting this story from the rooftops, but so far only the Entertainment and Showbiz blog has reported on it:

"The drug sildenafil has had mixed success as a drug for women, but according to Croatian researchers incorporating the stuff into a moisturiser could open up a whole new market, reports New Scientist."

Sildenafil is another word for Viagra.

" First, enzyme inhibitors like sildenafil had been shown to break down fat in test tubes, so it might do the same to fat deposited under the skin. And since Viagra famously boosts blood flow, a moisturizer containing the drug might break down fat and then whisk it away."

Here is a link to the original article, which was published last month in the journal Medical Hypotheses. Just like the title says, this is just a hypothesis, but an eye-catching one that might garner some big-time attention. It is estimated that 85% of women have some amount of cellulite, so it is a very common issue.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

American Academy for Anti-Aging Medicine

Finally, a meeting close to home. I, along with Drs. Haimes and Matez, attended the American Academy for Anti-Aging Medicine meeting this weekend in Orlando, Florida. I spoke about laser therapy for aesthetic purposes.

The meeting was quite interesting and Dr. Matez will be on here soon to provide highlights.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Pharrell gets laser tattoo removal: Important to see an expert

A big story in the gossip blogs right now is that rap star Pharell has gotten some of his tattoos removed with laser. There are no after pictures available right now but it sounds like the procedure went well.

It's of the utmost important for darker-skinned patients to go to an experienced laser expert when considering a procedure like this. You have to be very careful with tattoo removal... it's best to do a test spot on darker skinned patients prior to treatment, as the laser reacts differently than with lighter pigmentations.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

War on Fat 2: The Search for RF-Assisted Liposuction in Boca Raton

I just returned from Fort Collins, Colorado where I attended an Invasix Bodytite training for their upcoming IRB study on Radiofrequency-assisted lipoplasty (RFAL).

The meeting was hosted by Dr. Diane Duncan at her beautiful office and Dr. Steve Mulholland from Toronto. The purpose of this meeting was to review the data on RFAL and to watch a live surgery.

RFAL is an invasive liposuction that can be done under local tumescent anesthesia, IV sedation or general anesthesia. After fluid is infiltrated into the fat in the same way that it is done for other liposuctions, the RFAL device is inserted and used to melt fat, close blood vessels and most importantly to evenly heat the tissue and cause tightening of the skin and the fibrous attachments.

Advantages over laser liposuction are a more even and quicker skin heating, as well as a feedback system that shuts off the heat when optimal skin temperature is reached. It holds it there similar to a thermostat on an a/c or heating unit.

There seems to be more tightening than regular liposuction. Use of the device appears to be great for patients who have abdominal fat and some loose skin, but don't want or are marginal cases for a tummy-tuck.

There also may be uses for inner thigh tightening - a very difficult area for liposuction. Studies are being performed at a number of sites including at Sanctuary Plastic Surgery in Boca Raton, Florida, Dr. Diane Duncan in Fort Collins, Colorado, Dr. Malcolm Paul in Newport Beach, California and Dr. Spero Theodorou in New York.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

FDA to issue statement on illegal cosmetic surgery

From today's NY Times:

"Health department officials say there may be other cases that have gone unreported, since doctors are not legally obligated to report silicone poisoning or even death, and since silicone is hard to detect through X-rays or CT scans. The department was planning Thursday to send an advisory by e-mail and fax to thousands of doctors advising them to watch for silicone poisoning cases.

Nationally, reports of buttock enhancement using silicone and similar thick liquids have surfaced from the Northeast to Miami, and the Food and Drug Administration is also planning to issue a warning on the dangers of such practices, Siobhan DeLancey, a spokeswoman, said Thursday."

Dr. Jason Pozner

Sanctuary Medical Aesthetic Center

Sanctuary Plastic Surgery

Dr. David J. Goldberg

Sanctuary Medical Aesthetic Center

Skin Laser & Surgery Specialists of NY/NJ

For plastic surgery in Boca Raton, visit the new Sanctuary Plastic Surgery web site!

Our new website launched today and we are very excited about it.

Sanctuary Plastic Surgery


Let us know what you think!

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Another delay for Reloxin

From Bloomberg:
"April 14 (Bloomberg) -- Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC."

This isn't the first time Reloxin has gotten delayed; early last year, the FDA rejected Medicis' initial application, citing a paperwork snafu.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Synthetic Snake Venom: Is it just snake oil?

From the Telegraph:

"A new cream claims to smooth wrinkles using a synthetic form of the poison produced by Asian temple viper snakes.

The £6 tubes of Lacura Wrinkle Stop contain a compound called Syn-Ake, which mimics the snake's paralysing venom. It promises to block the nerve signals which cause facial muscles to contract and can lead to lines.

Tests show that twice-daily application of the cream for four weeks may reduce the appearance of wrinkles by 52 per cent. "

This is interesting. Lots of drugs come from toxin, so there may be actual benefits from this.

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

The War on Fat: Updates on Zeltiq and Ultrashape

Here's what happened at the ASLMS conference regarding Zeltiq and Ultrashape:

For Zeltiq, a study was presented by Elizabeth Tanzi from Washington D.C. Co-authors were Jeffrey Dover, A.J Burns, Syd Coleman, Richard Fitzpatrick, Jerome Garden, David Goldberg, Roy Geronemus, Suzanne Kilmer, Flor Mayoral, Robert Weiss and Brian Zelickson. It was titled "A prospective clinical study of noninvasive cryolipolysis for subcutaneous fat layer reduction - interim report of available subject data."

This was a multi-center, prospective, non-randomized, IRB-approved study of male and female patients with back or flank fat. One side was treated and the other side untreated as a control. There was interim data on 32 patients which showed a visible contour change in the majority of patients. 10 patients had Ultrasound measurements which showed an average reduction of 22.4% in all patients at 4 months.

What you need to know: This was a very promising study of this technology. As we've covered before, it has received its CE mark in Europe (the equivalent of FDA approval). And it was a hot topic at the American Academy of Dermatology meeting, the Hawaii Dermatology Seminar, the International Masters Course on Aging Skin conference, and the American Society of Plastic Surgeons meeting.

Dr. Goldberg was mentioned in the list of co-authors of the study and the tests were conducted at his practice, Skin Laser Surgery Specialists of NY/NJ.

A little more on Zeltiq from a previous post:

"Cryolipolysis by Zeltiq involves the precise delivery of cold to unwanted fat areas such as love handles. Initial work was done on animals, but data was recently presented at the American Society for Dermatologic Surgery meeting, showing that dramatic results can be seen in humans... Patients sit and read the newspaper while their fat is frozen away! Our NJ office is one of the FDA sites where we are treating love handles. "

Here is a four-month before/after after one treatment with Zeltiq:
Regarding Ultrashape, Guilherme Almeida, Leticia Almeida, Andrezza Facci, Elaine Marques, marcia Paes and Thais Notarangelli III, all of San Paulo, Brazil presented a study using external focused ultrasound for body contour with the new 1hz hand piece compared to the 3 hz hand piece.

This study showed results of 83 patients with 354 treatments with the Ultrashape's new 1hz hand piece (this was the hand piece we used in our US FDA trial at SMAC- see previous posts). Patients had 3 treatment sessions of all areas and were imaged with the Canfield's vectra 3d system. All patients showed at least 1.2cm of reduction of circumference per session with an average of 1.8cm. Satisfaction rate was 86%. Conclusions from this study comparing to previous treatments with the older handpiece were similar efficacy and 30% quicker treatment times.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Dispatch from ASLMS: Combining Fractional Ablative & Non-Ablative

Dr. Lawrence Bass, Director of Minimally Invasive Plastic Surgery at NYU Medical Center reported the results with simultaneous fractional non-ablative (1540 nm) and fractional ablative (fractional erbium, 2940 nm) laser therapy.

The percentage of skin covered in a single treatment was increased from 20-30% in a typical fractional erbium treatment to over 60%. Healing time increased by about 1 day (average 4-5 days). Despite this modest change in healing times, 86% of patients experienced at least a 50% improvement in wrinkle severity when graded by blinded doctors examining before and after photos at 3 months. 36% experienced a 75% or better improvement.

Skin tightening was also seen but this is the subject of ongoing study. This study demonstrated that wrinkle clearance similar to that seen with old-fashioned ablative laser resurfacing can be obtained, more consistently that what either stand-alone fractional treatment can produce.

Dr. Bass' website is located at http://www.drbass.info/.

Thanks for reading,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Lasers & Surgery Specialists of NY/NJ

ASLMS Wrap-Up: Check out my presentation on Miratone skin-tightening

We're back from the 29th annual American Society for Lasers in Surgery and Medicine meeting in Washington, D.C.

This meeting draws experts in the field of cosmetic lasers from across the globe into one place. Both Dr. Pozner and I are on the Board of Directors of this group and we will be describing the meeting, with some of our colleagues over the next few days.

I personally gave talks on the newest variety of Fraxel type lasers (including Solta Medical’s Fraxel re:pair, Lumenis’ Total FX, Cutera’s Pearl Fractional and Sciton’s ProFractional. I also presented our work on Primaeva’s newest non-invasive skin tightening technology. This machine will be marketed under the name of Miratone.

As you can see from this before/after that was presented, there was moderate improvement in skin tightening and rhytides three months post-treatment.

To see the rest of the presentation, just click here. Collaborating were Bradley J. Renton, PHD, James Newman MD, and Basil H. Hantash, MD, PHD.

Dr. David J. Goldberg
Skin Laser Surgery Specialists of NY/NJ
Sanctuary Medical Aesthetic Center

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Daily Links 4/6

1) My G-Cups Can't Handle G-Force [The Sun UK]

"The former Celebrity Big Brother winner refused to try out a "terrifying" new ride at Thorpe Park because she was concerned it might damage her breast implants.

The coaster hits between 4.0 to 4.7 Gs a total of six times throughout the 100-second ride giving passengers "a more extreme G-force experience than a space shuttle rocket launch".

My belief is that this would have been safe. I wonder if any astronauts have implants?

2) Laser Medicine and Surgery meeting features emerging applications [Press Release]

"Laser medicine experts from around the world are gathering this week and through the weekend in National Harbor, Maryland at the Annual Scientific Conference of the American Society for Laser Medicine and Surgery (ASLMS). Nearly 1500 laser specialists in aesthetic surgery, otolaryngology, ophthalmology, oncology, dermatology, photobiomodulation, and urology are attending, and about 130 industry exhibitors are showcasing their latest products."
Dr. Goldberg is the former president of the ASLMS and taught a course on laser hair removal there (after all, he literally wrote the book on laser hair removal).

We also presented some of our data on fractional laser skin resurfacing with a Sciton laser. We will post some slides later on.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Daily Links 4/2

1)AZZALURE(R) Is Approved In France For Aesthetic Use In The Treatment Of Frown Lines [Press Release]

"Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Paris:IPN), an innovation-driven international specialty pharmaceutical group, announced that Azzalure® (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in France from the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS).

The marketing approval is for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient. The approval was based on several clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure®."

Azzalure is what they call Dysport in France, which we call Reloxin here in the US. Check back soon for a genealogy chart explaining all of these products and how they intertwine.

2. Heads Up, Botox [NY Times]
"To be honest, if you just talk about aesthetics, there are no good comparative trials on Dysport and Botox,” said Dr. Berthold Rzany, an author of “Botulinum Toxin in Aesthetic Medicine” and the director of evidence-based medicine at Charité, the university hospital in Berlin, Germany. Only small studies exist, Dr. Rzany said, adding that at least 300 participants would be needed to prove that one of the drugs lasts longer. Choosing a longer-lasting product would matter to consumers because both drugs are expensive. In England, a visit for Botox or Dysport costs roughly $250 to $430, said Dr. John Curran, the former president of the British Association of Cosmetic Doctors. (There is no information yet about how it might be priced in the United States.)

3. Bronx Woman Dies After Botched Plastic Surgery [Newsday]
"Siordaliza Pichardo only wanted to add shape to her thighs and buttocks. Now, the Bronx mother of two is dead, killed during a botched plastic surgery procedure, authorities said.

...But after further tests were conducted and police were consulted, the ME on Tuesday declared the case a homicide and concluded the mother of two died of a "silicone pulmonary embolism," with the silicone clotting in her lungs. The ME also said the injections were performed by a "nonmedical, unlicensed person."
Yet another tragedy caused by unlicensed practitioners.