Galderma New Kit For Rosacea Treatment Is Still The Old MetroGel

Galderma Laboratories, L.P. today announced the availability of a new MetroGel(R) 1% Kit for the topical treatment of the inflammatory lesions of rosacea. The new kit contains a 60 gm tube of the leading topical prescription treatment for Rosacea, MetroGel(R) (metronidazole) Topical Gel, 1%. Also included in the kit is a complimentary 4 fl. oz. bottle of Cetaphil(R) Gentle Skin Cleanser, the number-one skin cleanser recommended by dermatologists, plus a patient education brochure with information about rosacea trigger factors, symptoms and treatment. The brochure contains a $2.00-off coupon for future purchases of Cetaphil(R) brand cleansers and moisturizers.
MetroGel(R) 1% Kit, with its additional contents, is the same cost as a regular 60gm tube of MetroGel(R) 1%, and the MetroGel(R) 1% Kit is currently available to rosacea patients in pharmacies nationwide. "This is a natural extension for our MetroGel(R) brand franchise. The combination of proven, effective treatments and patient education provides additional value to the patient," said Albert Draaijer, President of Galderma Laboratories, L.P.
MetroGel(R) 1%, incorporates a vehicle containing HSA-3(TM), a combination of niacinamide, betadex and propylene glycol. The vehicle is a water-based formulation and contains no alcohol. The product requires once-a-day dosing as opposed to twice-a-day for most other topical rosacea treatments.
According to a study published in the April 2006 issue of Cutis, "A good skin care regimen is a critical part of rosacea treatment, but care must be taken to choose products that do not irritate as rosacea patients typically have sensitive skin."(1) Cetaphil(R) Gentle Skin Cleanser is specifically formulated for dry, sensitive or compromised skin and will not strip the natural protective oils or emollients, or disturb the skin's natural pH balance.
"The beneficial effect of Cetaphil(R) Cleanser for the sensitive skin of rosacea patients has been verified in clinical trials. Combining MetroGel(R) 1% and Cetaphil(R) Cleanser in a Kit at no additional cost is of substantial value-and provides automatic convenience for rosacea patients," said Dr. James Del Rosso, a dermatologist practicing in Las Vegas, Nevada. (Personal Communication)
An estimated 14 million Americans suffer from rosacea, characterized by redness, flushing and blushing on the face. However, many people in the early stages of rosacea mistake their symptoms for sunburn, rash or acne, causing them to delay diagnosis and treatment. The chronic disorder primarily affects the cheeks, chin, nose and forehead. Unfortunately, without treatment, rosacea can worsen over time, with the initial redness worsening and becoming more persistent. Visible blood vessels may appear, bumps and pimples may form on the face, eyes may appear to be bloodshot, and eventually, excess tissue may develop on the nose. Recent surveys reveal that almost 70 percent of rosacea patients suffer socially and that their self-esteem is affected by the condition.(2)
The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities, and nausea

Does Milk Cause A Rosacea Flush?

Article may indicate that consuming milk will intensify a rosacea flush.

By Steven Reinberg
HealthDay Reporter

Plenty of studies have suggested that tea is a boon for cardiovascular health, but new research has found that adding milk to your favorite brew negates those benefits.
The culprits in milk is a group of proteins called caseins that interact with tea, decreasing the concentration of catechin -- the flavonoids in tea that are responsible for its protective effects against heart disease, according to the study authors.
"There are a lot of studies that show that tea is protective against cardiac diseases," said lead researcher Dr. Verena Stangl, professor of cardiology at the Charite Hospital, Universitatsmedizin-Berlin, in Germany. "If you look at the studies, you see that in Asia there are less cardiac diseases, but in England that's not the case. So the question is, is the addition of milk a reason for this difference between Asia and England, where tea is often taken with milk?" she said.
In the study, 16 healthy postmenopausal women drank either half a liter of freshly brewed black tea, black tea with 10 percent skimmed milk, or boiled water on three different occasions under similar conditions. The researchers then measured the function of the cells lining the brachial artery in the forearm, using high resolution ultrasound before and two hours after tea consumption.
Stangl's team found that black tea significantly improved the ability of the arteries to relax and expand. "But when we added milk, we found the biological effect of tea was completely abolished," she said.
Additional experiments on rat aortas and rat endothelial cells -- which line blood vessels -- found that tea relaxed the vessels. But adding milk blunted the effect.
"If you want to drink tea for its health effects, don't drink it with milk," Stangl said.
The study findings are published in the Jan. 9 online edition of the European Heart Journal.
Stangl noted that not only does milk block tea's benefits for blood vessels, it also destroys the antioxidant effects of tea and perhaps its cancer-protective effects as well.
She said her team is also comparing the effects of green and black tea on the function of blood vessels. "It's a question whether green tea, with its higher catechin content, is better than black tea in regard to endothelial function," she said.
One expert agreed that you should hold the milk when drinking tea.
"This is actually something we tell patients to do -- not to have milk in tea," said Dr. Robert Vogel, a professor of medicine at the University of Maryland Medical School.
Tea is one of the greatest sources of antioxidants, Vogel said. "In countries where they drink a lot of tea, heart disease is decreased, except for the British Isles. It is typical in Great Britain to add milk."
Vogel's advice is simple. "Add lemon not milk. You should not add milk or cream to tea -- it's a very good drink, but not with milk," he said.

Legal Issues For Rosacea's Dr. Bitter

Doctor faces sanctions over bogus Botox
By Barbara Feder
Ostrov Mercury News

A prominent Los Gatos dermatologist is facing sanctions from the state medical board for injecting patients, including his wife, with bogus Botox. Dr. Patrick Henry Bitter Jr., was among more than 200 doctors around the country who purchased experimental botulinum toxin, the main ingredient in wrinkle-relaxing Botox, from an Arizona company.

The toxin, which was not approved for human use, came to light in late 2004 when a doctor improperly mixed a batch, causing severe paralysis of four people in Florida. The doctors were customers of Tucson-based Toxin Research International, which illegally marketed the toxin to them as a cheap Botox substitute that would bring in higher profits. The company was shut down in early 2005 and its doctor-owners are in prison.

Bitter, who has appeared on the TV show ``Extreme Makeover'' and is nationally known for inventing the FotoFacial skin-treatment procedure, is one of several California doctors who have been investigated or disciplined by the medical board in recent months for using the unapproved drug. It's unclear what sanctions Bitter will face.

Any remaining unapproved toxin was relinquished to federal investigators, and no other major adverse effects were reported from its use. But experimental botulinum toxin is still being marketed to American doctors, primarily by overseas companies.

Bitter is the inventor of FotoFacial and PhotoFacial, pulsed light treatments for wrinkles, redness and rosacea used by doctors around the country. With his father, Dr. Patrick Bitter Sr., he continues to run the Advanced Aesthetic Dermatology clinic, offering skin treatments, Botox injections and liposuction among other cosmetic services.

He did not return phone calls from the Mercury News. The fallout from the Toxin Research International scandal continues as doctors around the country have been disciplined by regulators, indicted and even imprisoned for passing off the company's Botox knockoff as the real thing.

Use brings prison time In June, a New Mexico doctor was indicted on federal charges of fraud after giving the fake Botox to 120 patients.

Earlier this month, an Oregon doctor was sentenced to 18 months in federal prison for using two kinds of fake Botox, from Toxin Research International and a Chinese company, on more than 800 patients. An Idaho doctor also was sentenced to six months in prison in mid-December for using botulinum toxin from Toxin Research International.

Botox is a huge moneymaker for pharmaceutical firm Allergan, with 2005 sales topping $830 million.

It's a lucrative part of many dermatologists' and plastic surgeons' practices: Botox injections can cost consumers $250 or more per area treated, with the drug lasting only three to five months. A vial costs doctors about $500 and can yield treatment for up to eight areas.

Made from a purified form of the botulinum type A toxin that causes botulism, Botox has become so widely available that it is even injected by nurses in shopping mall ``medi-spas'' supervised by a physician. Botox also is used to treat neurological disorders, migraines and excessive sweating.

Botox works by causing temporary paralysis of facial muscles, relaxing them under the skin and thus smoothing wrinkles. Toxin Research International obtained the botulinum toxin from Campbell-based List Biological Laboratories, but investigators from the U.S. Food and Drug Administration could not establish that List had done anything illegal. List sells products designed to be used in scientific and medical research, and no charges were filed against the company.

While FDA investigators said Botox and the unapproved toxin appeared similar, using unapproved medicine is considered dangerous because there is no monitoring of storage, sterility or manufacturing practices.

The FDA might never have known about the bogus Botox if a Florida doctor with a suspended license hadn't made a nearly fatal error in mixing the potent toxin for injection in himself, his girlfriend and another couple. Within days, all four were paralyzed from a massive overdose causing botulism so severe they depended on ventilators to breathe. They remained hospitalized for weeks.

While three other doctors in California have received public reprimands for dispensing unapproved botulinum toxin -- one Temecula physician injected it into 200 patients -- the stories behind their cases were not made public by the medical board.

The board's accusation against Bitter, the only one made public, alleges that the board-certified dermatologist lied when he told its investigators in January that he did not know the knockoff Botox was not to be used on humans.

In fact, he had admitted months earlier to FDA investigators that he knew the product wasn't intended for human use. Bitter purchased the unapproved toxin from Toxin Research International for more than a decade, at least until February 2004, according to the medical board investigation.

He admitted that he injected the toxin into himself, his wife and four patients between December 2003 and March 2004. There is no information about whether the toxin Bitter administered caused any adverse effects, but typically the medical board would detail such harm if it had occurred.

Bitter also did not tell his patients that he was using a product meant only for research and did not maintain any paperwork on the injections for himself, his wife and one of his patients, the medical board has charged.

Range of penalties To the medical board, those actions constitute ``gross negligence'' and ``extreme departures'' from the standard practice of medicine.

Bitter faces penalties that could include fines, probation or even revocation of his license. He could, however, face only the public reprimand given the other California doctors who used the Botox knockoff.

Bitter is contesting the board's move to sanction him, but a hearing date has not been set. Consumers who stick with FDA-approved Botox shouldn't worry, said Dr. Michael Kane, a Manhattan plastic surgeon and author of ``The Botox Book.'' `

`Botox itself is a tremendously safe product; they have great quality control,'' Kane said. But, he cautioned, research-grade botulinum toxin and counterfeit Botox still are available on the black market and a determined doctor could simply inject a bogus product into an actual Botox vial. Potential patients can research their doctors on the Internet as a basic precaution, he said, but there are no guarantees. ``It's tough to really protect yourself,'' Kane said. `

`If someone is basically evil, you can get the bad stuff.''

Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.