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.

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.

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.

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.

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.

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.