Radiesse makes the grade: Multicenter study establishes safety of calcium hydroxylapatite filler in darker skin types

November 1, 2008

A multicenter study enrolling 100 patients investigated the safety of calcium hydroxylapatite microspheres (Radiesse, BioForm) injection for treatment of nasolabial folds. After follow-up to six months, there were no clinically significant adverse reactions, including no cases of keloids, hypertrophic scarring or hypo- or hyperpigmentation.

Key Points

Chicago - Subdermal injection of calcium hydroxylapatite microspheres (Radiesse, BioForm) is an effective, safe and well-tolerated technique for improving the appearance of nasolabial folds in patients with skin of color, according to the results of a multicenter, open-label study.

The study was conducted at five centers and enrolled 100 patients with Fitzpatrick skin types IV to VI.

At scheduled follow-up visits conducted after three and six months, response was assessed, but the main objective of the study was to characterize safety.

All participants were evaluated at three months, and 98 were followed at six months. At both intervals, there was no evidence of any of keloids, hypertrophic scarring, hypo- or hyperpigmentation, or any other clinically significant adverse events.

"There has been limited data on use of injectable fillers in persons with skin of color. Concern about potential adverse reactions has made some of these individuals reluctant to be treated," says Ellen S. Marmur, M.D., chief, division of dermatologic and cosmetic surgery, and assistant clinical professor, Mount Sinai Medical Center, New York.

"This is the first large-scale trial of calcium hydroxylapatite injection in patients with dark skin types. The positive results should liberate a large segment of the population to feel confident about undergoing this very effective and gratifying procedure," she says.

Study details

The patients included in the study represented a mix of racial-ethnic groups. The majority were African-American (85 percent), and there were also patients of Hispanic (12 percent) and Asian (2 percent) origin. About one-fourth of the patients were categorized as Fitzpatrick skin type IV, 35 percent were skin type V, and 41 percent had skin type VI. There were 94 women and six men. The mean age for the patients was 52 years.

Calcium hydroxylapatite was injected into the subdermis with a 27-gauge needle using a linear threading technique and a volume ranging from 0.6 ml to 2.4 ml (mean 1.24 ml) to achieve desired correction.

Patients were eligible for touch-up at six months. Follow-up at this time showed good persistence. Of patients who did receive a touch-up, almost all were small volume using the 0.3-ml syringe.

Benefits

"The data from this study are exciting, considering the benefits of calcium hydroxylapatite for providing durable improvement for a variety of indications. It is approved for treatment of moderate-to-severe facial wrinkles and folds, which is the focus of the safety study.

"However, clinical experience shows it also has good safety and efficacy for chin augmentation, cheek augmentation, nonsurgical rhinoplasty, and for restoring volume in aging hands," Dr. Marmur says.

Market statistics underline the importance of establishing the safety of injectable fillers in skin of color patients.

Consumers are increasingly interested in minimally invasive rejuvenation techniques, and fillers are one of the most popular cosmetic procedures.

Wrinkles and folds are a prominent feature of aging in persons with skin of color, who represent a large and growing proportion of the U.S. population.

Disclosure: Dr. Marmur is a member of the BioForm Medical Education faculty. BioForm provided investigators with product and equipment for the procedures.

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