Posts Tagged “fda”

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For mild-to-moderate acne in patients 12 and older, the FDA has approved a once-a-day gel that combines adapalene and benzoyl peroxide gel (Epiduo Gel 0.1%, 2.5%), the drug maker announced.

According to Galderma, the combination gel “treats both inflammatory and non-inflammatory lesions with no evidence of promoting antibiotic resistance, simplifying the management of mild-to-moderate acne.”

The approval followed a 517-patient phase II trial published last year in the Journal of the American Academy of Dermatology that found the gel reduced the median number of total acne lesions by more than 50% by the end of the 12-week study.

That was significantly better than monotherapy with either adapalene or benzoyl peroxide (median reduction in total lesion count 35.4% and 35.6%, respectively), said the company.

A long-term safety and efficacy study published last year in the Journal of Drugs in Dermatology found that discontinuation of the medication because of adverse events was low, occurring in 2% of all patients.

Common adverse effects included redness, scaling, dryness, stinging, and burning. Skin irritation and contact dermatitis may also occur.

Excessive exposure to sunlight and topical products containing resorcinol, salicyclic acid, and sulfur should be avoided while using the drug, said the company.

Have you heard of Thermaclear? It is expensive acne treatment. Not sure how well it works but it is now going mainstream to a mall near you.

Therative announced today that their FDA-cleared Acne Clearing Device, ThermaClear, will expand retail distribution into Sephora stores nationwide. Once exclusively available on the web, including Sephora.com, ThermaClear’s new widespread partnership with the leading specialty beauty retailer will mark its first availability on store shelves.

“The decision to move from online to in-store distribution has been a natural progression for the company,” said Sandra Lawrence, CEO of Therative. “We hope that by maintaining our accessibility on the web and bringing ThermaClear to over 200 Sephora store locations, we can better serve our customer, the millions who suffer from acne and breakouts.” Read the rest of this entry »

No matter what the circumstance, the old saying is true, you never get a second chance to make a first impression. Whether it’s a job interview or a first date, you always want to look your best. But according to researchers, acne affects 25 percent of adult men. Unfortunately for guys, if you get a pimple, your options are limited. After all, you can’t exactly cover it with makeup like the ladies would, but you have to get rid of it fast, so what do you do?

Of course, there are creams of all kinds that can treat blemishes for you, everything from simple over the counter fixes to the stuff you see on the TV infomercials. The problem for most guys is that they don’t want to mess around with something they have to apply every day, and they don’t want their skin to look dry and cracked either.

There is a high tech solution that makes this annoying problem go away. It’s a little gadget you can keep on your bathroom counter, or carry along with you in your gym bag or briefcase. Luiz Da Silva invented ThermaClear, a hand-held anti-acne device that many men say they can’t live without. It uses heat technology, similar to the laser treatments you’d receive in a dermatologist’s office, only on a much smaller scale, to fight mild-to-moderate acne. Read the rest of this entry »

Differin is becoming a common product to battle acne. It was only approved by the FDA in 2007 so the overall benefits of it are still not known. It is recommended as a good option for moderate to severe acne though. It is available by prescription and many medical professionals are finding it is getting their patients positive results.

How does Differin work?

Differin (or adapelene) is a gel that doesn’t have any odor to it. Many users like that because so many other acne medications have a strong scent to them. This product is able to penetrate deep down into the pores so it can help to stop acne outbreaks before they even start. Read the rest of this entry »

The makers of Aczone announced today that Health Canada has completed its review of Aczone labeling supplement for Aczone and has removed the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements.

“We are extremely pleased to report Health Canada’s decision to remove the need for blood monitoring from the Aczone label,” said Bob Butchofsky, President and Chief Executive Officer of QLT. “This positive review, along with the FDA’s recent decision to also remove the need for blood monitoring from the Aczone label, validates our regulatory strategy, increases Aczone’s commercial potential, and enhances the product’s overall attractiveness to potential acquirers.”

Aczone was originally approved by Health Canada in June 2006 with a similar label restriction as that required by the US Food and Drug Administration (FDA). The label called for all patients to undergo G6PD screening and for those patients with this enzyme deficiency, regular blood monitoring was required during Aczone treatment. On March 17, 2008 the Company announced that the FDA removed the G6PD screening and monitoring requirements based on a Phase IV clinical trial in 56 safety-evaluable G6PD-deficient patients. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. Data was analyzed by third party clinical experts in dermatology and hematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial. Read the rest of this entry »