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New Study Shows Isolaz Can Reduce Acne Up to 90 Percent

SANTA MONICA, Calif., Feb. 1 /PRNewswire-FirstCall/ -- Southern California-based dermatologist Ava Shamban, MD and co-investigators Mikiko Enokibori, MD, and Vic Narurkar, MD, conducted a global multi-center study using Isolaz to treat patients suffering from various degrees of acne, ranging from mild and moderate inflammatory acne to severe nodular and cystic acne.

The February edition of the Journal of Drugs in Dermatology will report the results of this study using the Isolaz device (Aesthera Corp(TM), Pleasanton, CA) for the treatment of mild to severe acne.

Prospective and retrospective data was collected from 56 patients who had undergone two to four treatments with a photopneumatic device (Isolaz). Evaluation criteria included lesion counts, using blinded physician evaluations of acne clearance, as well as treatment satisfaction surveys given to the participating physicians and patients.


Isolagen Modifies Ongoing Clinical Program For Acne Scars

FDA has provided follow-up on the Phase III program investigating Isolagen's Therapy for the treatment of moderate to severe acne scars. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies. However, the FDA asked the Company to further clarify certain protocol issues and raised questions related to the acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended that in order to address these issues, the Company should conduct a Phase II study; therefore, the Company will propose modifying the ongoing Phase III Study IT- A-008 as a Phase II/III study (as discussed further below). The FDA requests are specific to the acne scar clinical program and do not impact the Company's ongoing, pivotal Phase III clinical program evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.Isolagen's two randomized, double-blind, placebo-controlled acne scar clinical trials (IT-A-008 and IT-A-009) of approximately 120 patients eachwere designed and powered as Phase III studies.


Isolagen Initiates Phase III Clinical Program to Investigate Isolagen ...

EXTON, Pa., Nov. 7 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX: ILE) announces the initiation of a Phase III clinical program to investigate Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. Isolagen also has a pivotal Phase III clinical program underway to evaluate the Isolagen Therapy in treating nasolabial folds, or wrinkles.

"Millions of people in the U.S. suffer from acne which often scars, a condition that can be very distressing and difficult to treat as there are few options currently available," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Isolagen. "We are pleased to be initiating this important clinical development program which we believe will address this largely unmet medical need."

Two randomized, double-blind, placebo-controlled trials will evaluate the safety and efficacy of Isolagen Therapy in patients with moderate to severe acne scarring on both sides of the face.


Acne Drug Accutane Ups Cholesterol

In a study involving almost 14,000, mostly young patients taking the drug, elevations in blood cholesterol, triglycerides (a blood fat), and a blood liver function test were more common than have been previously reported.

Blood levels returned to normal or to pretreatment levels in the vast majority of patients in the months after they stopped taking Accutane, however.

Researchers say this finding is reassuring, but they add that patients should be followed longer to see if there are long-term implications for cardiovascular and liver disease risk.

"We do want to know if there are long-term consequences, but that was not a part of this research," researcher Michele Manos, PhD, MPH, tells WebMD.

Tighter Controls on Drug

First approved in 1982 for the treatment of severe disfiguring acne , Accutane use in women has long been linked to an increased risk of miscarriage and birth defects.


Reid helps Sunderland's learner drivers steer clear of relegation

Roy Keane likens his Sunderland side to an improving learner driver with cause for cautious optimism about passing their test in May. Since starting weekly lessons last August there have been moments of despair but, these days, the instructor is not looking quite so nervous and has reason to believe that clutch control could soon be perfected.

"It's a bit like driving lessons. We're getting more and more right and we now need to do all the good things at the same time to pass the test," explained Keane, whose hopes of avoiding relegation were boosted by a fourth consecutive home league win which leaves Sunderland four points clear of the drop zone and three ahead of Wigan.

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Counting Bones With Nina Nastasia

The mirror behind the Mohawks inside stage produces an oddly unsettling effect. The frosted glass reflects another world, one paralleling its own wood and brick reality. The audience stares dumbed upon themselves, and the performer is left naked and open in the hindsight. Seated before the full room with only her acoustic guitar Wednesday night, it seemed an appropriate environment for Nina Nastasia.

The New Yorkers songs have always exposed an unnerving intimacy, her powerful voice confidently pitching high and whispering soft in a confessional paradoxically strengthened in her own insecurities. Yet there was also an easy reciprocation from the crowd, who seemed largely her friends, in the discarding of hard stances, the following of her intimations through the looking glass.


KELLER'S WWE RAW REPORT 2/4: Ongoing "virtual time" coverage of live ...

KELLER'S WWE RAW REPORT FEBRUARY 4, 2008 TAPE DELAY FROM AUSTIN, TEX. WHAT HAPPENED: 1ST HOUR -A full pyro show opened the show. Then Randy Orton was shown standing in mid-ring as Jim Ross and Jerry Lawler introduced the show. Orton said John Cena accepted his invite to wrestle him at No Way Out for the WWE Title. He said Cena's word means nothing to him, so he wants it in writing so there's no way he can back out of the match in two weeks. He said Cena therefore cannot claim he is not fully recovered. He was there to be "no way out" for Cena. Get it? He said he had his lawyers draw up the contract, which he has already signed. He called Cena to the ring. Cena came out and signed the document quickly. Orton told him that if he suffers a pec injury later in an arm wrestling contest against Mark Henry, he'll still have to fulfill his match at No Way Out.


 
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