A Potential New Filler Application Use For A New Cause - HIV Associated Facial Lipoatrophy

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Many Americans that suffer from HIV associated lipoatrophy have been aided in the last few years by other FDA approved dermal filler agents that have limited length of stay. Artefill would offer these same patients a more permanent solution to facial lipoatrophy and an improved quality of life.

"The quest for a more permanent facial filler solution for patients with HIV associated lipoatrophy may soon become a reality with Artefill®

Early this year, Anthony Caglia, M.D. was appointed to the HIV advisory board of Suneva Medical Inc., San Diego, California Company that manufactures the long-term filler Artefill®. This injectable microsphere-enhanced dermal implant is currently approved by the FDA for the cosmetic correction of nasolabial folds. Artefill® consists of 20% polymethylmethacrylate microspheres (PMMA) and 80% purified bovine collagen with 0.3% lidocaine used for anesthesia to ease injection discomfort. Currently there are two soft tissue fillers approved by the FDA for HIV associated facial lipoatrophy; (Sculptra®) Poly-L-Lactic Acid and (Radiesse®) Calcium Hydroylapatite both of which are semi-permanent filler materials. With multiple treatments these fillers are able to restore a patient to a normal facial contour, however, they only typically last from 14-24 months . "The quest for a more permanent facial filler solution for patients with HIV associated lipoatrophy may soon become a reality with Artefill®," said Dr. Caglia.

A meeting on February 27, 2010 took place at the Suneva Medical Headquarters with company representatives and a panel of 8 other physician board members to discuss the use of ArteFill® in HIV associated facial wasting.

During this meeting the advisory panel discussed their experience managing this disease and in particular the challenges of managing facial lipoatrophy. Dr. Caglia shared his experience in facial fillers and use of Artefill® in a case report of a single patient he had treated. The advisory board made definitive recommendations regarding study design considerations for a pivotal trial to substantiate the safety and efficacy of Artefill® for this new indication. These recommendations and the proposed design have been reviewed at Suneva with anticipated trials to begin late this fall.

On March 23, 2010 the Center for Medicare and Medicaid Services announced it would begin covering the cost of FDA approved treatments for facial lipoatrophy, which is typically caused by antiretroviral drug use in those patients that have associated diagnosis of depression. "This is the first in many milestones to come," said Dr. Caglia. "Not long ago breast implants were not covered after surgical mastectomy for breast cancer. After Medicare covered them other insurance carriers followed suite and this is what should be expected for treating HIV associated lipoatrophy," explains Dr. Caglia. Gaining FDA approval for ArteFill® would provide healthcare providers another treatment alternative in their therapeutic armamentarium that could potentially offer greater durability of effect in contrast to the currently approved fillers for this condition. The treatment of facial lipoatrophy is not just a cosmetic therapy as noted by the Center for Medicare and Medicaid Services recent decision; if offers these patients quality of life and self-image enhancement which may also reduce depressive symptoms often associated with the stigmatism of facial fat loss.

Dr. Caglia's cosmetic dermatology & laser surgery practice (Derm Aesthetics & Laser Center) is located in the Dallas/Plano area where he provides custom programs coupled with personalized care to meet the needs of each patient. Dr. Caglia treats a variety of pigmented, vascular, and acne skin conditions with laser treatments as well as laser hair removal. He also uses state of the art Fractional CO2 (SmartXide DOT) laser resurfacing for lax, wrinkled, and sun damaged skin, stretch marks and acne scars. He has the latest technology in Laser Liposuction with SlimLipo body contouring, Botox for wrinkles and excessive sweating (Hyperhidrosis), and leg veins. For facial contouring and wrinkles various dermal filler products (Radiesse®, Sculptra®, Artefill®, Juvederm®, Restylane®) are now an option. Other medical treatments for warts, hair loss, precancerous lesions, skin tags, melasma and moles are also available. You may contact Dr. Caglia's office at Derm Aesthetics & Laser Center cosmetic surgery and cosmetic laser surgery]for an appointment at 972-690-7070 or go to our web site at http://www.dermlasercenter.net and you can subscribe to our newsletter for educational information and special offerings and join us on Facebook at http://www.facebook.com/dermaesthetics and Twitter at http://www.twitter.com/dracaglia.


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Anthony Caglia, M.D.
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