Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results.
BACKGROUND
Calcium hydroxylapatite (CaHA, Radiesse) is approved by the Food and Drug Administration for treatment of moderate to severe wrinkles and folds, including nasolabial folds (NLF). A pivotal NLF split-face study previously compared the performance of Radiesse to human-based collagen at six months and safety of Radiesse through one year.


OBJECTIVE
The authors assess the long-term safety and effectiveness of Radiesse for the treatment of NLF. Postapproval long-term results now extend to more than three years and are presented here.


METHODS
This study reports an extension phase of a previously reported one-year premarket study of 117 patients comparing Radiesse to collagen. During the initial study, patients were treated to optimal correction and then followed for 12 months; they were offered retreatment with Radiesse between six and 12 months in both folds to balance asymmetry. Of the 117 original split-face study subjects with moderate to severe NLF, 102 were enrolled in this extended follow-up. During this extension study, treating physicians used the Global Aesthetic Improvement Scale (GAIS) and clinical examination to evaluate subjects at intervals up to 39 months after the last injection of Radiesse.


RESULTS
Forty percent of the folds evaluated at least 30 months after the last Radiesse treatment were graded as "improved" or better on the GAIS. Expectedly, the reported improvement was substantially less at this later time point than had been seen at earlier points in the premarket study, indicating some moderate, sustained improvement in some patients. There were no long-term or delayed-onset adverse events in these 102 patients followed for three years, including no reports of nodules, granulomata, or infections, such as have been reported with certain other dermal fillers.


CONCLUSIONS
These results demonstrate the long-term safety and effectiveness of Radiesse. Three years after Radiesse injection, no delayed-onset or long-term adverse events were reported. In addition, many patients showed some long-term cosmetic improvement. The durability and safety of Radiesse compare favorably with other injectable fillers.
Bass
Lawrence S
LS
Institute of Reconstructive Plastic Surgery, New York University School of Medicine, New York, New York, USA. DrBass@DrBass.net
Smith
Stacy
S
Busso
Mariano
M
McClaren
Marla
M
D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D003357:Cosmetic Techniques; D017886:Durapatite / Q000008:administration & dosage* / Q000009:adverse effects; D005145:Face; D005782:Gels; D006801:Humans; D007267:Injections; D008863:Microspheres; D017060:Patient Satisfaction; D015361:Rhytidoplasty / Q000295:instrumentation*
D001672:Biocompatible Materials; D005782:Gels; D017886:Durapatite