Radiesse
Approved for Facial Lipoatrophy by FDA On
December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable
(under the skin) implant to restore or correct signs of facial lipidatrophy [lipoatrophy],
or fat loss, in people with human immunodeficiency virus (HIV). Radiesse,
a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite
suspended in a gel carrier, is a medical device. It is already approved for use
as a tissue marker, for treatment of vocal fold insufficiency, and to correct
certain dental defects. The
safety and effectiveness of Radiesse for the treatment of facial lipoatrophy was
evaluated in a prospective, open-label, multi-center study of 100 patients with
human immunodeficiency virus and facial lipoatrophy. Study subjects were at least
18 years of age, HIV positive, with a CD4 count >250 cells/mm3 and viral load
<5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years,
and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial
Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic,
non-smoking males (94% male) with a mean age of 48 years. Forty-four percent (44%)
of patients were Black, Hispanic or Asian. Fifty-six percent (56%) percent were
Caucasian. Patients
received an initial treatment (initial injection and an additional injection at
1 month as needed). Six months later, all patients were assessed for the need
for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from
initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating,
cheek skin thickness measurements, and patient satisfaction assessment. Safety
was assessed by the recording of adverse events through 12
months. All
treatments were performed with a 25 gauge, 1 and one-half inch needle. Mean initial
treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month
if necessary (85% of patients were treated at 1 month). At 6 months, the mean
touch up volume was 2.4 mL (89% of patients). Four percent (4%) of patients received
only one treatment, 18% of patients received a total of two treatments, and 78%
of patients received a total of three treatments. No patient received more than
three treatments. Mean
left cheek thickness measurements at baseline was 4.7 mm (N=100). At 3 months,
the mean thickness was 7.3 mm (N=100), representing an increase of 2.6 mm from
baseline, with P-Value = 0.0001. At 6 months the mean thickness was 7.1 mm (N=97),
representing an increase of 2.4 mm from baseline, with a P-Value = 0.0001. Mean
cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months,
the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from
baseline, with a P-Value of 0.0001. At 6 months the mean thickness was 7.5 mm
(N=97), representing an increase of 2.7 mm from baseline, with a P-Value of 0.0001. The
most common adverse events reported were temporary edema (swelling), ecchymosis
(bruising), erythema (reddening) and/or pain at the injection site. The
calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and
CT Scans. It is important that patients inform their doctor and other health care
professionals that they have had Radiesse injected in the face. In a radiographic
study of 58 patients, there was no indication that Radiesse potentially masked
abnormal tissues or was interpreted as tumors in CT Scans. | 
In
late December, the U.S. Food and Drug Administration (FDA) approved Radiesse,
a new injectable therapy for the treatment of facial fat loss (lipoatrophy) in
people with HIV; Radiesse was also approved as a cosmetic treatment for moderate-to-severe
facial wrinkles and folds.
