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.

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.

Acne And Rosacea Getting You Down? Laser, Light And Cosmetic Treatments Give Patients A Much Needed Boost

It is estimated that approximately 50 million people in the United States alone are affected by acne vulgaris, and another 14 million Americans experience the redness, flushing and pronounced blood vessels associated with rosacea. While there are no cures for these persistent skin conditions, dermatologists are broadening their treatment options to include laser, light and cosmetic therapies that are proving effective in managing these conditions and improving patient satisfaction.

Speaking at the 66th Annual Meeting of the American Academy of Dermatology, dermatologist Jenny J. Kim, MD, PhD, FAAD, assistant professor of medicine and dermatology at the David Geffen School of Medicine, University of California at Los Angeles (UCLA), in Los Angeles, Calif., discussed the latest approaches for treating acne, acne scarring and rosacea with laser and light therapies by themselves, in combination with each other or with cosmetic treatments, such as fillers.

Skincare for Acne: Newest Skin Care Solutions for Scars and Blemishes

Skincare-News.com discusses advanced treatment options for acne scars.

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.

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.

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.

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.

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.

Acne And Rosacea Getting You Down? Laser, Light And Cosmetic Treatments Give Patients A Much Needed Boost

It is estimated that approximately 50 million people in the United States alone are affected by acne vulgaris, and another 14 million Americans experience the redness, flushing and pronounced blood vessels associated with rosacea. While there are no cures for these persistent skin conditions, dermatologists are broadening their treatment options to include laser, light and cosmetic therapies that are proving effective in managing these conditions and improving patient satisfaction.

Speaking at the 66th Annual Meeting of the American Academy of Dermatology, dermatologist Jenny J. Kim, MD, PhD, FAAD, assistant professor of medicine and dermatology at the David Geffen School of Medicine, University of California at Los Angeles (UCLA), in Los Angeles, Calif., discussed the latest approaches for treating acne, acne scarring and rosacea with laser and light therapies by themselves, in combination with each other or with cosmetic treatments, such as fillers.

Skincare for Acne: Newest Skin Care Solutions for Scars and Blemishes

Skincare-News.com discusses advanced treatment options for acne scars.

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.

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.

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.