Speaking here at the Cosmetic Dermatology Seminar, Dr. Humble addressed the Historical use of New-Fill in Europe and its transformation in the United States as Sculptra, indicating that this filler will endure time due to the product's longevity as a "revolumizer." While the primary ingredient in the filler, polylactic acid, was first synthesized by a French chemist in 1954 and showed value in non-absorbable sutures, fixation devices and urethral and tracheal stents, its capabilities for cosmetic purposes have only been realized in the last decade.
Impressive, reimbursable longevity "The effects of New-Fill in lipoatrophy patients remain at least 18 months, although I don't think patients ever go back to baseline," says Dr. Humble, medical director of Blue Pacific Aesthetic Medical Group, Hermosa Beach, Calif.Of most interest, Dr. Humble explains, is that the filler not only works well in patients with lipoatrophy due to HIV, it is also the first product approved to treat this condition.
Lipoatrophy is felt to be multifactorial. In the beginning it was felt to be due to the class of drugs known as protease inhibitors, (used to treat HIV). Now it is felt to be due to the disease process itself, medications used to treat it and the normal aging process.
Documented evidence In 2002, Dr. Humble and partner Doug Mest, M.D. enrolled 100 patients to receive one to six treatments of Sculptra spaced three weeks apart. Caliper skin thickness was used to measure changes in transcutaneous thickness. Baseline labs were taken and repeated every three, six and 12 months to verify no change in lactic acid level, in addition to a well-being questionnaire filled out prior to treatment, at the end of treatment, and at six and 12 months follow up.
Throughout the study there were no serious adverse results, with 9.2 percent of the patients noting small and transient nodule formation, according to Dr. Humble. There was occasional ecchymoses, with pain level being 1.7 on a scale of one to five. Additionally, there were no clinically significant changes in serum lactate levels.
"In the older European experiences that were published, they had a higher percentage of nodule formation," Dr. Humble says. "The technique for injecting has changed with Sculptra. Sculptra comes in powder form. The dilution has been changed to 5 cc of sterile water as apposed to the original 3 cc. It is used in a grid pattern at a 30 to 45 degree angle." Massage is very important, according to Dr. Humble, to decease the incidence of granuloma formation.
For the follow-up protocol number two, which is under way, Dr. Humble says that injections of Sculptra will be done at five-week intervals, as opposed to three-week intervals. The powder should be reconstituted with 5 ccs of sterile water to consist of 150 mg of PLA per 5 ccs, and may be mixed with some lidocaine. The patient receives an infraorbital block either intraorally or transcutaneously with injections in the malar, temple, neck, infraorbital and perioral areas, and the chin and hands.
"The results in supplementing facial volume loss have been quite impressive, with the end result out-performing those seen by Artecoll and silicone," Dr. Humble says. "For those with lipoatrophy, cheek transplants do not work and fat transplantation does not work because they have no fat. Sculptra will be of great help to those with HIV, and the aging population overall."