A Potential New Filler Application Use For A New Cause - HIV Associated Facial Lipoatrophy
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.
September 21, 2010 - 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 www.dermlasercenter.net and you
can subscribe to our newsletter for educational information and special offerings and join us on Facebook at www.facebook.com/dermaesthetics and
Twitter at www.twitter.com/dracaglia .
Anthony Caglia, M.D.
Derm Aesthetics & Laser Center
"Reproduced with permission - Derm Aesthetics & Laser Center "
Derm Aesthetics & Laser Center