Follow-Up Study Finds Calcium Hydroxylapatite Safe at 4 Years

WAIKOLOA, HAWAII — Calcium hydroxylapatite, injected as an implant for soft-tissue augmentation of the nasolabial folds and other facial areas, was safe after 4 years of follow-up in a two-center study of over 100 patients.

The investigators found that results lasted about 8 months for the majority of patients; results lasted longer (about 10–12 months) in patients who received multiple injections and touch-up sessions.

Dr. Bruce E. Katz of the department of dermatology at Mount Sinai School of Medicine, New York, described the findings (Dermatol. Surg. 2007;33:122–7) during a presentation at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The 113 patients in the study ranged in age from 26 to 78 years; 100 of them were women. The nasolabial folds were injected in 86 patients. A single injection was given at a single session to 75 patients (66%), and 38 (34%) had more than one session, said Dr. Katz. Most patients were given a 1-mL injection of calcium hydroxylapatite at a session; 12 were given a 2-mL injection.

Calcium hydroxylapatite (Radiesse) is a synthetically sourced, semipermanent, soft-tissue filler that comprises 25- to 45-mcm microspheres suspended in an aqueous gel. The microspheres "form a scaffold for tissue growth," he said. The calcium hydroxylapatite particles degrade over time to calcium particles and phosphate ions. "This material is highly biocompatible, it's durable, it does not migrate, it's not antigenic, and it's [radiopaque]."

Seven patients in the study reported adverse events, which were short term and minor, resolving within a month, according to Dr. Katz. These adverse events included three cases of transient ecchymoses, two patients with inflammation and edema, and two with nongranulomatous submucosal nodules of the lip.

A subset of 41 patients rated efficacy of treatment on a scale of 1 (satisfactory) to 5 (excellent), he said. The mean score of visual satisfaction after treatment was 4.6. The mean scores of those physicians who rated results using the same scale were 4.5 for visual satisfaction and 4.6 for the feel of the implant. At 6 months' follow-up, patients' mean scores were 4.8 for visual satisfaction and 4.9 for the feel of the treatment; physicians' mean scores were 4.5 for visual satisfaction and 4.9 for feel.

Dr. Katz has received compensation from BioForm Medical Inc. for making presentations on calcium hydroxylapatite.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

WAIKOLOA, HAWAII — Calcium hydroxylapatite, injected as an implant for soft-tissue augmentation of the nasolabial folds and other facial areas, was safe after 4 years of follow-up in a two-center study of over 100 patients.

The investigators found that results lasted about 8 months for the majority of patients; results lasted longer (about 10–12 months) in patients who received multiple injections and touch-up sessions.

Dr. Bruce E. Katz of the department of dermatology at Mount Sinai School of Medicine, New York, described the findings (Dermatol. Surg. 2007;33:122–7) during a presentation at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The 113 patients in the study ranged in age from 26 to 78 years; 100 of them were women. The nasolabial folds were injected in 86 patients. A single injection was given at a single session to 75 patients (66%), and 38 (34%) had more than one session, said Dr. Katz. Most patients were given a 1-mL injection of calcium hydroxylapatite at a session; 12 were given a 2-mL injection.

Calcium hydroxylapatite (Radiesse) is a synthetically sourced, semipermanent, soft-tissue filler that comprises 25- to 45-mcm microspheres suspended in an aqueous gel. The microspheres "form a scaffold for tissue growth," he said. The calcium hydroxylapatite particles degrade over time to calcium particles and phosphate ions. "This material is highly biocompatible, it's durable, it does not migrate, it's not antigenic, and it's [radiopaque]."

Seven patients in the study reported adverse events, which were short term and minor, resolving within a month, according to Dr. Katz. These adverse events included three cases of transient ecchymoses, two patients with inflammation and edema, and two with nongranulomatous submucosal nodules of the lip.

A subset of 41 patients rated efficacy of treatment on a scale of 1 (satisfactory) to 5 (excellent), he said. The mean score of visual satisfaction after treatment was 4.6. The mean scores of those physicians who rated results using the same scale were 4.5 for visual satisfaction and 4.6 for the feel of the implant. At 6 months' follow-up, patients' mean scores were 4.8 for visual satisfaction and 4.9 for the feel of the treatment; physicians' mean scores were 4.5 for visual satisfaction and 4.9 for feel.

Dr. Katz has received compensation from BioForm Medical Inc. for making presentations on calcium hydroxylapatite.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.

WAIKOLOA, HAWAII — Calcium hydroxylapatite, injected as an implant for soft-tissue augmentation of the nasolabial folds and other facial areas, was safe after 4 years of follow-up in a two-center study of over 100 patients.

The investigators found that results lasted about 8 months for the majority of patients; results lasted longer (about 10–12 months) in patients who received multiple injections and touch-up sessions.

Dr. Bruce E. Katz of the department of dermatology at Mount Sinai School of Medicine, New York, described the findings (Dermatol. Surg. 2007;33:122–7) during a presentation at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

The 113 patients in the study ranged in age from 26 to 78 years; 100 of them were women. The nasolabial folds were injected in 86 patients. A single injection was given at a single session to 75 patients (66%), and 38 (34%) had more than one session, said Dr. Katz. Most patients were given a 1-mL injection of calcium hydroxylapatite at a session; 12 were given a 2-mL injection.

Calcium hydroxylapatite (Radiesse) is a synthetically sourced, semipermanent, soft-tissue filler that comprises 25- to 45-mcm microspheres suspended in an aqueous gel. The microspheres "form a scaffold for tissue growth," he said. The calcium hydroxylapatite particles degrade over time to calcium particles and phosphate ions. "This material is highly biocompatible, it's durable, it does not migrate, it's not antigenic, and it's [radiopaque]."

Seven patients in the study reported adverse events, which were short term and minor, resolving within a month, according to Dr. Katz. These adverse events included three cases of transient ecchymoses, two patients with inflammation and edema, and two with nongranulomatous submucosal nodules of the lip.

A subset of 41 patients rated efficacy of treatment on a scale of 1 (satisfactory) to 5 (excellent), he said. The mean score of visual satisfaction after treatment was 4.6. The mean scores of those physicians who rated results using the same scale were 4.5 for visual satisfaction and 4.6 for the feel of the implant. At 6 months' follow-up, patients' mean scores were 4.8 for visual satisfaction and 4.9 for the feel of the treatment; physicians' mean scores were 4.5 for visual satisfaction and 4.9 for feel.

Dr. Katz has received compensation from BioForm Medical Inc. for making presentations on calcium hydroxylapatite.

SDEF and SKIN & ALLERGY NEWS are wholly owned subsidiaries of Elsevier.