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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.
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.
SLU researchers to look at laser treatment for acne scars
ST on Monday, January 14, 2008 ST. LOUIS (AP) -- Researchers at the Saint Louis University School of Medicine plan to test a special laser treatment that might improve acne scars on people with darker skin. The scars are difficult to remove. Physicians usually treat the scars by removing the surface of the skin with powerful lasers or chemical treatments. These treatments can cause discoloration for people with darker skin. Dermatologists at Saint Louis University plan a clinical trial to see if a gentler laser treatment might help. The technique would use lasers that bypass the surface of the skin and stimulate collagen growth underneath. .
Skincare for Acne: Newest Skin Care Solutions for Scars and Blemishes
Skincare-News.com discusses advanced treatment options for acne scars. Sacramento, CA (PRWEB) January 30, 2008 -- Acne can cause a host of changes in the skin and, leave behind a few parting gifts: scars or hyper-pigmentation. But can these marks ever be vanquished? Skincare-News.com's latest article, "Options for Acne Scars," discusses several brand-new advanced treatment options available which can improve the appearance of acne scars.
http://www.skincare-news.com/articles.php?ArtID=500 What are acne scars? According to Skin Care: Beyond the Basics, (acne) scars form when "the skin, in a desperate attempt to heal itself, produces lots of collagen to try to compensate for the lack of normal skin functioning." The result can be anything from a red spot or macule, to a raised scar to the typical 'pit' scarring commonly seen with more aggressive forms of acne.
Patients Seek Better Results in Nonsurgical Cosmetic Treatments
WALTHAM, Mass., Nov. 14 /PRNewswire/ -- Physicians attending the American Society of Dermatologic Surgery in Chicago were invited to a Hot Topics session on the latest advances in plasma skin regeneration. Co-moderated by Richard Fitzpatrick, MD, and Christopher Zachary, MD, the session focused on new studies, expanded protocols, treatment of acne scars, skin tightening -- especially around the eyes -- and delivering CO2-like results with less recovery time. Presentations were made by a world-renowned faculty that included Drs. Kenneth Arndt, Brian Biesman, Jeffrey Dover, David Goldberg and Nathan Uebelhoer. According to David Goldberg, MD of Skin Laser & Surgery Specialists of New York & New Jersey, "The reason why this technology all of a sudden is becoming very exciting is that the whole pendulum with what we are trying to accomplish is swinging back with patients wanting to see some results.
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