Trial Information

A Phase IV, Prospective, Non-Blinded, Non-Randomized, Single-Center Clinical Trial to Determine the Longevity, Duration, and Volume-Correcting Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy

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.