• Volume correction and longevity of correction [ Time Frame: at 12 and 24 months ]
  

• Safety in non-HIV positive subjects
  

Soft tissue fillers are used to temporarily fill facial lines and wrinkles and augment contour deformities. There are a variety of soft tissue fillers available.

Sculptra™ has been used to correct dermal atrophy in both the HIV and non-HIV populations. Almost all clinical trials have used a visual assessment scale to grade correction as well as persistence. Recently, dermal ultrasound has been used to provide an objective measurement of dermal thickening, but the ultrasound procedure measures only a fraction of the dermis and is subject to a high degree of variability because of the difficulty in measuring the same area. Our protocol utilizes the Primos ½ face system to produce a 3-dimensional evaluation of a large area. This will produce excellent reproducible results as well as outstanding photographs for patient demonstration.

Sculptra™ is an injectable implant that contains microparticles or poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra™ is reconstituted prior to use by the addition of sterile water for injection, USP (SWFI) to form a sterile non-pyrogenic suspension.

Comparison:

Dermik's Vega Study - The Vega study was a 96-week, open-label, uncontrolled, single-center study to determine the treatment effects of Sculptra on the signs of lipoatrophy of the face in 50 patients infected with human immunodeficiency virus. Patients had a mean age of 45 years (range 33-58), 84% were Caucasian and 98% were male. All patients had little or no adipose tissue in cheek area at baseline, indicating severe facial lipoatrophy (mean adipose thickness of 0.5±0.7 mm, ranging from 0.0 to 2.1 mm).

Treatment injection sessions were conducted at approximately two-week intervals, and the majority (86%) of the patients received four to five injection sessions. Generally, one vial of product was injected intradermally into multiple points of each cheek at each injection session. The quantity of injected product and number of injection sessions depended upon the severity of the facial depression.

All patients experienced increases in skin thickness in the treatment area (minimum increase of 2.2 mm noted at Week 8 visit). Statistically significant increases above baseline values of mean skin thickness were noted at all time points (Weeks 8, 24, 48, 72 and 96) during the study. Increases in mean skin thickness changes above baseline persisted for up to 2 years.

This study follows the same general design as the Vega study.