Purpose: The purpose of this study is to assess the safety and efficacy of subcutaneous injections of Radiesse™ to restore facial contours in patients with HIV-associated facial lipoatrophy.

Methods: One hundred (100) patients with HIV-associated facial lipoatrophy were enrolled into the one year study between July 2004 and August 2004 at three (3) centers. Inclusion criteria included a grade 2, 3 or 4 on the Carruthers Facial Lipoatrophy Severity Scale (grade 1 being mild and localized lipoatrophy; grade 2 being deeper and longer atrophy with the facial muscles beginning to show through; grade 3 defined as atrophic areas that are even deeper and wider with the muscles clearly showing through; and grade 4 defined as atrophic areas covering a wide area extending up towards the eye sockets with the facial skin lying directly on the muscles). All patients had facial skin depth measurements, a facial global aesthetic improvement rating (GAIS rating) and photographs taken at baseline, and at three (3) month visits. Patient satisfaction with the treatment was documented at follow-up visits. Restorative treatment by Radiesse (Calcium Hydroxylapatite microspheres suspended in a resorbable carrier gel) injections were initially performed at baseline, and touch-up injections were provided four (4) weeks and twenty-four (24) or twenty-eight (28) weeks later, if indicated. Photographic documentation was performed at each visit.

Results: At 4 months, the average volume of product injected at baseline was approximately 5 mls per patient. 85% of the patients received a touch-up injection. The average volume injected at the touch-up treatment was approximately 2 mls. There were no unanticipated adverse events or complications. The results at three months after treatment (four months if the patient received a touch-up injection at four weeks) as measured by the GAIS scale were: 26% very much improved, 72% much improved, 2% improved, 0% no change and 0% worse. Patient satisfaction measures were consistently positive.

Conclusions: This study showed that patients treated with Radiesse had improved aesthetic outcomes after three months and were very pleased with their results. Radiesse is a safe and effective product for facial soft tissue augmentation in patients with HIV-associated lipoatrophy with low morbidity and high patient satisfaction. It fosters a significant improvement in the quality of life of these patients. Continuing follow-up of these patients will determine the longevity of this treatment.