|
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.
Adult sufferers find acne is hard to face
Age lines and acne? This wasn't supposed to happen. Acne, normally the bane of teenagers, was flaring up on Kim Noble's 50-year-old face, causing the Atlanta businesswoman no small degree of frustration. "I started when I was a teenager with acne problems, and as I got older, it got worse," she says. "I was told it was due to stress and hormones. I've tried everything that was out there, from (rubbing) alcohol to injections to Accutane to Proactiv," says Noble, who has been seeing a dermatologist for years but still has flare-ups. She's not alone. Dr. Jodi Ganz, an Atlanta dermatologist, estimates half her patients are adults with mild to severe acne breakouts. "There are a ton of people with adult acne. For women, flare-ups usually occur the week before their periods; that's what we call hormonally linked acne.
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.
|
