Lipodystrophy Workshop
Toronto, Sept 13-15, 2000

Abstract:

The Effects of Polylactic Acid (PLA) as Therapy for Lipoatrophy of the Face
(please be cautious in using this information. The abstract seems a little like an advertisemenT)

Authors: P Amard, T Saint-Marc (Dept of Clinical Immunology Hopital E Herriot Lyon, France, P Katz

PLA is a biocompatible and bioabsorabable new generation implant which is responsible for new collagen formation.

The objective of this study is to dtermine if intradermal PLA injections are associated with an increase in dermal thickness of the cheeks in patients reporting lipoatrophy of the face.

Intradermal PLA injections were assessed in patients who had developed fat wasting (FW) of the face under ARV therapy. Patients received a total of 4 injections, each performed every 2 weeks (3cc in each cheek). FW of the face was defined by physical exam. Ultrasonography of the cheeks was performed by the same radiologist on day-14, and at weeks 12 and 24, allowing for measurements of dermal and fat thickness.

Results: Data are available in 26 male patients. Patients were aged 28 to 61 years, with CD4 counts ranging from 21 to 800; 87% were on combination therapy including a PI, and 38.5% had undetectable virus loads (<200 copies/ml). Mean baseline dermal thickness was 2.7 mm. FW was severe in 20/26 patients (fat thickness less than or equal to 1 mm), and moderate in 5/26 (fat thickness: 1-1.9 mm). Mean dermal thickness rose by 4.1 mm (151% increase) and 5.31 (196% increase) at weeks 12 and 24, respectively (p=0.0001). In 22/26 patients, ARV related adverse events had resolved completely (patients admitting to have the face shaped as prior to facial change). The authors concluded that our data confirm the beneficial effects of intradermal PLA injections on facial lipoatrophy while maintaining antiretroviral therapy.

The authors reported that all patients showed major improvements in their condition. The improvement was already noticeable after the first injection, but became obvious after the second injection and definitive in most patients (54.5% by the fourth one. Maximum improvement occurred by the second injection in 1 patient (3.1%), and by the third injection in 6 patients (18.2%). It occurred by the fifth one in 6 patients (24.2%).

At week 12 the mean fat thickness decreased by 0.02 mm (-3.54%) and the mean dermal thickness increased by 4.12 +/- 1.87 mm (+130.06%), whereas at week 24, the mean fat thickness increased by 0.014 mm (+3.11%) and the mean dermal thickness increased by 5.3 +/- 0.85 mm (+153.9%). Intradermal injections were well tolerated.

Authors reported following:

Response to PLA Injections in 33 patients with Facial Fat Wasting (same study)

(there was a standard deviation associated with Fat Thickness numbers & Dermal Thickness numbers but there wasn't enough room to show it.

Background from abstract at Workshop:

PLA (proprietary name New-Fill-registered trademark) is a biocompatible bioabsorbable and immunologically inactive new generation implant. It contains no product of animal origin and is perfectly tolerated by the body. There is no risk of allergic reaction: no preliminary skin tests are required.

New-Fill has to be distinguished from 2 other briad classes of implants:

--biodegradeable implants (of animal or biological origin):

• collagen

• hyaluronic acid

--synthetic, non biodegradeable implants: liquid silicone

Following injection, the action of New-Fil is based on a dual mechanism:

Immediate mechanical action

This is proportional to the quantity injected and relates to the hydrogel volume. This effect is tansient and induces the formation of new colagen as a result of PLA properties.

Delayed action

This is due to the development of a fibrous dermal layer in response to the presence of the implant (neocollagenosis), which is responsible for the filling action. This process of new collagen formation persists despite resorption of the PLA microparticles.

PLA was shown to be effective in treating fine lines, cutaneous wrinkles and furrows or creases, cheekbones.