A Multicenter, 47-Month Study of Safety and Efficacy of Calcium Hydroxylapatite for Soft Tissue Augmentation of Nasolabial Folds and Other Areas of the Face

Authors

  • NEIL S. SADICK MD,

    1. Private Practice, Sadick Dermatology, New York, New York, and Weill Medical College, Cornell University, New York, New York
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  • BRUCE E. KATZ MD,

    1. Private Practice, New York, New York, and Cosmetic Surgery & Laser Center, Mt. Sinai Medical Center, New York, New York
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  • DEBORSHI ROY MD

    1. Private Practice, Sadick Dermatology, New York, New York, and Division of Facial Plastic and Reconstructive Surgery, Lenox Hill Hospital, New York, New York
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Address correspondence and reprint requests to: Neil S. Sadick, MD, Sadick Aesthetic Surgery and Dermatology, 911 Park Avenue, New York, NY 10021, or e-mail: nssderm@sadickdermatology.com

Abstract

OBJECTIVES Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group.

METHODS After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle.

RESULTS Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively.

CONCLUSIONS In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction.

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