Friday, July 29, 2011

FDA OKs Xeomin for Frown Lines

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Washington — The Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA, Merz Aesthetics) for temporary improvement of moderate to severe glabellar lines, Medscape Today reports. 

According to a Merz statement, the approval is based on the results of two multicenter U.S. clinical trials involving 547 healthy adults. In both studies, Xeomin injections significantly improved the appearance of glabellar lines in 30 days when compared with placebo. Headache was the most common adverse reaction observed. 

Under the brand name Bocouture, Xeomin is already approved in 14 European countries including Germany, the United Kingdom, France, Italy and Spain. It was FDA-approved in 2010 for the treatment of cervical dystonia and blepharospasm. 

Xeomin will be available nationwide in the spring of 2012, Merz officials said.


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Wednesday, July 27, 2011

Sunscreens Exposed: 9 Surprising Truths

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EWG's Skin Deep

Sunscreens Exposed: 9 surprising truths

  Sunscreens prevent sunburns, but beyond that simple fact surprisingly little is known about the safety and efficacy of these ubiquitous creams and sprays. FDA’s failure to finalize its 1978 sunscreen safety standards both epitomizes and perpetuates this state of confusion. EWG’s review of the latest research unearthed troubling facts that might tempt you to give up on sunscreens altogether. That’s not the right answer – despite the unknowns about their efficacy, public health agencies still recommend using sunscreens, just not as your first line of defense against the sun. At EWG we use sunscreens, but we look for shade, wear protective clothing and avoid the noontime sun before we smear on the cream. Here are the surprising facts:

1. There’s no consensus on whether sunscreens prevent skin cancer.

The Food and Drug Administration’s 2007 draft sunscreen safety regulations say: “FDA is not aware of data demonstrating that sunscreen use alone helps prevent skin cancer” (FDA 2007). The International Agency for Research on Cancer agrees. IARC recommends clothing, hats and shade as primary barriers to UV radiation and writes that “sunscreens should not be the first choice for skin cancer prevention and should not be used as the sole agent for protection against the sun” (IARC 2001a).

2. There’s some evidence that sunscreens might increase the risk of the deadliest form of skin cancer for some people.

Some researchers have detected an increased risk of melanoma among sunscreen users. No one knows the cause, but scientists speculate that sunscreen users stay out in the sun longer and absorb more radiation overall, or that free radicals released as sunscreen chemicals break down in sunlight may play a role. One other hunch: Inferior sunscreens with poor UVA protection that have dominated the market for 30 years may have led to this surprising outcome. All major public health agencies still advise using sunscreens, but they also stress the importance of shade, clothing and timing.

3. There are more high SPF products than ever before, but no proof that they’re better.

In 2007 the FDA published draft regulations that would prohibit companies from labeling sunscreens with an SPF (sun protection factor) higher than “SPF 50+.” The agency wrote that higher values were “inherently misleading,” given that “there is no assurance that the specific values themselves are in fact truthful…” (FDA 2007). Scientists are also worried that high-SPF products may tempt people to stay in the sun too long, suppressing sunburns (a late, key warning of overexposure) while upping the risks of other kinds of skin damage.

Flaunting FDA’s proposed regulation, companies substantially increased their high-SPF offerings in 2011. Nearly one in five products now lists SPF values higher than “50+”, compared to only one in eight in 2009, according to EWG’s analysis of more than 600 beach and sport sunscreens. Among the worst offenders are Walgreens and CVS stores and Neutrogena. Walgreens’ boasts of SPF higher than “50+” on nearly half of its sunscreens; CVS and Neutrogena make the same misleading claim on about a third of theirs.

4. Too little sun might be harmful, reducing the body’s vitamin D levels.

Adding to the confusion is the fact that sunshine serves a critical function in the body that sunscreen appears to inhibit — production of vitamin D. The main source of vitamin D in the body is sunshine, and the compound is enormously important to health – it strengthens bones and the immune system, reduces the risk of various cancers (including breast, colon, kidney, and ovarian cancers) and regulates at least 1,000 different genes governing virtually every tissue in the body (Mead 2008). Over the last two decades, vitamin D levels in the U.S. population have been decreasing steadily, creating a “growing epidemic of vitamin D insufficiency” (Ginde 2009a). Seven of every 10 U.S. children now have low levels. Those most likely to be deficient include children who are obese or who spend more than four hours daily in front of the TV, computer or video games (Kumar 2009).

Experts disagree on the solution. The American Medical Association has recommended 10 minutes of direct sun (without sunscreen) several times a week (AMA 2008), while the American Academy of Dermatology holds that “there is no scientifically validated, safe threshold level of UV exposure from the sun that allows for maximal vitamin D synthesis without increasing skin cancer risk” (AAD 2009). Vitamin D supplements are the alternative, but there is debate over the proper amount. The Institute of Medicine has launched new research to reassess the current guidelines. In the meantime, your doctor can test your vitamin D levels and give advice on sunshine versus supplements.

5. The common sunscreen ingredient vitamin A may speed the development of cancer.

Recently available data from an FDA study indicate that a form of vitamin A, retinyl palmitate, when applied to the skin in the presence of sunlight, may speed the development of skin tumors and lesions (NTP 2009). This evidence is troubling because the sunscreen industry adds vitamin A to 30 percent of all sunscreens.

The industry puts vitamin A in its formulations because it is an anti-oxidant that slows skin aging. That may be true for lotions and night creams used indoors, but FDA recently conducted a study of vitamin A’s photocarcinogenic properties, the possibility that it results in cancerous tumors when used on skin exposed to sunlight. Scientists have known for some time that vitamin A can spur excess skin growth (hyperplasia), and that in sunlight it can form free radicals that damage DNA (NTP 2000).

In FDA’s one-year study, tumors and lesions developed up to 21 percent sooner in lab animals coated in a vitamin A-laced cream (at a concentration of 0.5%) than animals treated with a vitamin-free cream. Both groups were exposed to the equivalent of just nine minutes of maximum intensity sunlight each day.
It’s an ironic twist for an industry already battling studies on whether their products protect against skin cancer. The FDA data are preliminary, but if they hold up in the final assessment, the sunscreen industry has a big problem. In the meantime, EWG recommends that consumers avoid sunscreens with vitamin A (look for “retinyl palmitate” or “retinol” on the label).

6. Free radicals and other skin-damaging byproducts of sunscreen.

Both UV radiation and many common sunscreen ingredients generate free radicals that damage DNA and skin cells, accelerate skin aging and cause skin cancer. An effective sunscreen prevents more damage than it causes, but sunscreens are far better at preventing sunburn than at limiting free radical damage. While typical SPF ratings for sunburn protection range from 15 to 50, equivalent “free radical protection factors” fall at only about 2. When consumers apply too little sunscreen or reapply it infrequently, behaviors that are more common than not, sunscreens can cause more free radical damage than UV rays on bare skin. 

7. Pick your sunscreen: nanomaterials or potential hormone disruptors.

The ideal sunscreen would completely block the UV rays that cause sunburn, immune suppression and damaging free radicals. It would remain effective on the skin for several hours and not form harmful ingredients when degraded by UV light. It would smell and feel pleasant so that people use it in the right amount and frequency.

Unsurprisingly, there is currently no sunscreen that meets all of these criteria. The major choice in the U.S. is between “chemical” sunscreens, which have inferior stability, penetrate the skin and may disrupt the body’s hormone systems, and “mineral” sunscreens (zinc and titanium), which often contain micronized- or nano-scale particles of those minerals.

After reviewing the evidence, EWG determined that mineral sunscreens have the best safety profile of today’s choices. They are stable in sunlight and do not appear to penetrate the skin. They offer UVA protection, which is sorely lacking in most of today’s sunscreen products. Mexoryl SX (ecamsule) is another good option, but it’s sold in very few formulations. Tinosorb S and M could be great solutions but are not yet available in the U.S. For consumers who don’t like mineral products, we recommend sunscreens with avobenzone (3 percent for the best UVA protection) and without the notorious hormone disruptors oxybenzone or 4-MBC. Scientists have called for parents to avoid using oxybenzone on children due to penetration and toxicity concerns.

8. Europe’s better sunscreens.

Sunscreen makers and users in Europe have more options than in the United States. In Europe, sunscreen makers can select from among 27 chemicals for their formulations, compared to 17 in the U.S. Companies selling in Europe can add any of seven UVA filters to their products, but have a choice of only three when they market in the U.S. European sunscreens could earn FDA’s proposed four-star top rating for UVA protection, while the best U.S. products would earn only three stars. Sunscreen chemicals approved in Europe but not by the FDA provide up to five times more UVA protection; U.S. companies have been waiting five years for FDA approval to use the same compounds. Last but not least, Europeans will find many sunscreens with strong (mandatory) UVA protection if proposed regulations in Europe are finalized. Under FDA’s current proposal, Americans will not.

9. The 34th summer in a row without final U.S. sunscreen safety regulations.

In the United States, consumer protection has stalled because of the FDA’s 33-year effort to set enforceable guidelines for consumer protection. EWG has found a number of serious problems with existing sunscreens, including overstated claims about their perfomance and inadequate UVA protection. Many of these will be remedied if and when the FDA’s proposed sunscreen rule takes effect. But even after the rule is enacted, gaps will remain. FDA does not consider serious toxicity concerns such as hormone disruption when approving new sun filters. The new rules would also still allow sunscreen makers to use ingredients like vitamin A that can damage the skin in sunlight, and would fail to require makers to measure sunscreen stability despite ample evidence that many products break down quickly in sunlight. 

This article can also be viewed at http://bit.ly/noZpOg

Tuesday, July 26, 2011

Cutaneous Laser Therapy: Recent Medical Advances: Expert Commentary & Five-year View

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Expert Commentary & Five-year View

With expanding knowledge of light-tissue interaction, there has been exciting progress in the development of new light sources in addition to the modification of current laser technology for dermatologic indications. Practitioners of laser therapy continue to explore new treatment indications for existing technology, such as treating PWSs with alexandrite laser and hidradenitis suppurativa with Nd:YAG laser.

Additional work dedicated to improving the efficacy of selectively targeting different structural components of skin are ongoing. The addition of heat extraction in cryolipolysis opens the door for selectively targeting cellular populations, in addition to fat, that are thermally sensitive. Moreover, the immediate wide acceptance of fractional photothermolysis for cutaneous remodeling heralds a new understanding of skin's ability to regenerate after injury. Further studies will focus on utilizing the regeneration of skin after fractional thermal injury to remodel damaged skin, such as burn scar.

By: Daniel I Wasserman and Gary S Chuang

Monday, July 25, 2011

Two Topicals Boost Botox Treatment

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Omaha, Neb. — Botox users looking to enhance their skin appearance may want to try a new combination of two topical skin treatments, Medical News Today reports. 

A new study, co-authored by Omaha dermatologist Joel Schlessinger, M.D., suggests that a specifically designed 4 percent hydroquinone skincare system in combination with tretinoin (Retin-A) further enhances improvements in skin appearance attained with onabotulinumtoxinA (Botox, Allergan). Applying the hydroquinone system plus tretinoin may offer multiple clinical benefits over standard skincare, including significantly milder fine lines/wrinkles and hyperpigmentation, according to the research. 

In the multicenter, randomized study, 61 patients who had received upper facial Botox treatment were randomly assigned to use either the hydroquinone system (cleanser, toner, proprietary 4 percent hydroquinone, exfoliant and sunscreen) plus 0.05 percent tretinoin cream, or a standard regimen (cleanser, moisturizer and sunscreen) for 120 days. Outcomes were assessed by investigators and through a patient questionnaire. 

Compared with standard skincare, the hydroquinone system plus tretinoin resulted in significantly milder fine lines/wrinkles and hyperpigmentation at days 30, 90 and 120 and in significantly superior overall ratings for each of nine patient assessments at days 90 and 120. More than 85 percent of the patients in the hydroquinone system plus tretinoin group said their treatment had further enhanced Botox-attained improvements, as compared with 8 percent of the standard skincare group. Both regimens were generally well tolerated. 

Medical News Today quotes Dr. Schlessinger as saying, “The new hydroquinone system is not only effective, it is also easy for patients to use, increasing the likelihood that they will be able to get maximum benefits. Most importantly, using the system in combination with tretinoin significantly improved how patients perceived themselves, which is the ultimate goal of any aesthetic treatment.” 

The study appears in the July issue of Aesthetic Surgery Journal.

This article can also be viewed at http://bit.ly/nntkFf


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Friday, July 22, 2011

CosmetAssure Adds 3 New States


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Birmingham, Ala. — CosmetAssure, a company that insures against complications arising from cosmetic surgery procedures, has been approved to offer coverage in three more states, The Birmingham News reports.

Regulators in Nevada, Minnesota and Utah have OK’d CosmetAssure, bringing to 45 the number of states in which the company does business. 

More than 500 plastic surgeons nationwide provide CosmetAssure insurance for their patients. The company is working to expand into remaining areas, including New York, the nation’s largest cosmetic surgery market.



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Thursday, July 21, 2011

NFL Player Injuries Linked to Low 'D'

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Berkeley Heights, N.J. — Vitamin D deficiency may be unusually high among American football players, with black players and those with muscle injuries showing significantly lower levels, Medscape Today reports. 


Berkeley Heights orthopedic surgeon Michael K. Shindle, M.D., led a research team that tested the vitamin D levels of 89 players from the National Football League’s New York Giants in the spring of 2010. 

Investigators found that 27 players — about 30 percent — had deficient total 25-hydroxy vitamin D levels (below 20 ng/mL) and as many as 45 players — just over half — had levels consistent with vitamin D insufficiency (between 20 and 31.9 ng/mL). 


Meanwhile, only 17 players — about 19 percent — had vitamin D levels that were within normal limits.
The percentage of players with abnormal vitamin D levels was “alarming,” according to Dr. Shindle.
Researchers also found that all players who had suffered injuries that caused them to miss at least one practice or game had vitamin D levels significantly lower than players with no muscle injury. 


Of the players tested, 31 were white and 58 black. Noting that blacks generally tend to have lower vitamin D levels than whites, Medscape Today quotes Dr. Shindle as saying, “Up to 93 percent of African-American players had abnormal vitamin D levels, compared with 31 percent of white players.” 


The study was presented at the annual meeting of the American Orthopaedic Society for Sports Medicine, held recently in San Diego.

This article can also be viewed at: http://bit.ly/nfWCvt



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Thursday, July 14, 2011

Scientists ID Sunburn 'Pain Molecule'

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London — Researchers at King’s College here say they have identified the exact molecule that causes the stinging pain of sunburn — a finding, Time.com reports, that could lead to improved treatments for more serious conditions, such as arthritis. 

The culprit is a protein called CXCL5 that attracts inflammatory immune cells to damaged tissue, which in turn triggers sunburn sting. 

To identify the protein, investigators asked healthy participants to expose small areas of their skin to UVB radiation. The exposed patches began to exhibit tenderness after a few hours and hit their pain peak one to two days later. At that point, the research team biopsied the affected skin to look for proteins associated with the pain. 

Several of these pain mediators, including CXCL5, were overexpressed. Scientists then used rats to confirm their theory that CXCL5 was the sunburn-pain culprit and found that CXCL5 was overexpressed in sunburned skin in rats as well. They found that when rats were given an antibody that targeted and neutralized CXCL5, the sensitivity to pain was greatly reduced. 

Time.com quotes study leader professor Stephen McMahon as saying, “We hope that we have identified a potential target which can be utilized to understand more about pain in other inflammatory conditions like arthritis and cystitis. I’m excited about where these findings could take us in terms of eventually developing a new type of analgesic for people who suffer from chronic pain.”

This article can also be viewed at: http://bit.ly/mXeign



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