The US Food and Drug Administration has approved an injectable treatment called Radiesse for the correction of facial fat loss in people with HIV, it announced last week.
Radiesse consists of microspheres of synthetic calcium hydroxylapatite suspended in a gel carrier, and is injected under the skin where it stimulates the production of new collagen. This leads to a thickening under the surface of the skin that restores volume in sites where fat has been lost. Radiesse is already marketed for the correction of facial wrinkles and scars in the United States.
Radiesse is the second facial filler to be approved for treatment of lipoatrophy in the US; Sculptra (polylactic acid), which is widely used in Europe, was approved in the US in August 2004.
Radiesse manufacturer BioForm Medical states that the treatment’s effect on wrinkles is not permanent, and typically lasts one to two years.
Radiesse has not been studied for longer than one year in people with HIV-associated lipoatrophy.
A clinical trial in 100 people with moderate to severe facial lipoatrophy gave an initial treatment and a follow-up treatment one month later where needed. Restoration was evaluated six months later, when participants received further injections where needed.
All treatments were performed with a 25 gauge, 1½ inch needle. Mean initial treatment volumes were 4.8ml for the initial treatment and 1.8ml after one month if necessary (85% of patients were treated at 1 month). At six months, the mean touch up volume was 2.4ml (89% of patients). Four percent 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 4.7mm (N=100). At three months, the mean thickness was 7.3mm (N=100), representing an increase of 2.6 mm from baseline (p = 0.0001). At six months the mean thickness was 7.1mm (N=97), representing an increase of 2.4 mm from baseline (p = 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 (p=0.0001). At six months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline (p = 0.0001).
The most common adverse events reported were temporary swelling, bruising, reddening and/or pain at the injection site.