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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.
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.
Britney Spears and Adnan: ‘Classiest Couple ‘08’
Britney Spears and her paparazzi man-candy Adnan Ghalib have been embarking on daily shopping sprees over the past week. One stop was the Betsey Johnson store in Sherman Oaks where Britney apparently came out of a dressing room buck-ass naked, according to Life & Style: "I was blown away. Britney's private parts were right in front of me!" a store employee tells Life & Style.
"I grabbed a dress to cover her and she screamed, 'Get away from me! Don't you f------ come near me!' says the employee.
"Then she disappeared in the dressing room with Adnan for 45 minutes. They were making weird noises. It was disgusting." When Britney and Adnan finally came out, what followed is probably the most accurate description of how I imagine Britney talking: "I couldn't understand a word she was saying.
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