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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.
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. .
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.
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.
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. .
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.
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.
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