Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands.
To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months.
This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed.
A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies.
Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.
*Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc., San Diego, California;
†Private Practice, Vista, California;
‡Tennessee Clincal Research Center, Nashville, Tennessee;
§Cosmo Plastic Surgery, Great Neck, New York;
‖Texas Pharmaceutical Research LP/Research Across America, Plano, Texas;
¶Juva Skin and Laser Center, New York, New York
Address correspondence and reprint requests to: Mitchel P. Goldman, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc., 9339 Genesee Avenue, Suite 300, San Diego, CA 92121, or e-mail: firstname.lastname@example.org
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Sponsored by Merz North America, Inc.
All authors have been investigators and/or consultants for Merz North America, Inc. Michael Hast provided editorial help with this manuscript, but not full medical writing assistance.