Prospective Clinical Trial Evaluating the Long-Term Safety and Efficacy of Calcium Hydroxylapatite for Chest Rejuvenation

May 2021 | Volume 20 | Issue 5 | Original Article | 534 | Copyright © May 2021


Published online April 16, 2021

Sabrina G. Fabi MD, Marwan Alhaddad MD, Monica Boen MD, Mitchel Goldman MD

Cosmetic Laser Dermatology, Goldman, Fitzpatrick, Butterwick, Groff, Fabi, Wu & Boen, San Diego, CA

Abstract
Background: Calcium hydroxylapatite (CaHA) is indicated for correcting moderate-to-severe facial wrinkles and folds. Hyperdilute CaHA is increasingly being used for stimulating neocollagenesis to improve skin quality and firmness.
Objective: This study assessed long-term effects of hyperdilute CaHA for improving chest wrinkle appearance.
Methods and Materials: Adult female subjects (N=20) were treated with a 1:2 dilution of CaHA and evaluated at week 6, week 12, day 180, and day 360 using validated Merz Décolletage Scales. A Subject Satisfaction Questionnaire was used to assess overall satisfaction on a scale from 0 (Completely Dissatisfied) to 6 (Completely Satisfied).
Results: Subjects achieved significant improvements in baseline Merz Décolletage Scale–Dynamic scores at week 6, after a single treatment (P=0.02), at week 12 (two treatments) (P=0.01), day 180 (P=0.01), and day 360 (P<0.01). Subjects also demonstrated significant improvement in baseline Merz Décolletage Scale–At Rest scores at week 6 (P<0.01), remaining significant at week 12 (P<0.01), day 180 (P<0.01), and day 360 (P<0.01). Subject Satisfaction scores increased from 3.25 at day 180 to 3.59 at day 360 using a 7-point scale. Conclusion: Hyperdilute CaHA significantly improves the dynamic and resting appearance of wrinkles of the décolleté. These durable improvements persist for at least 1 year.

J Drugs Dermatol. 20(5):534-537. doi:10.36849/JDD.5680

INTRODUCTION

The use of dermal fillers is the second most prevalent, minimally invasive aesthetic procedure performed in the United States, reaching 2.6 million in 2018.1 Among the available dermal fillers, calcium hydroxylapatite (CaHA) has emerged as a well-tolerated, semi-permanent injectable filler with unique filling and lifting capabilities2 (Radiesse® Injectable Implant; Merz Aesthetics, Raleigh, NC). The beneficial effects of CaHA are due to its ability to produce immediate augmentation of soft tissue and a prolonged neocollagenesis with long-term deposition of new collagen.3-5 CaHA is indicated for the correction of moderate-to-severe facial wrinkles and creases, such as nasolabial folds and is especially well-suited for improving areas prone to volume loss including the temple, zygomatic arch, anterior cheek, pyriform aperture and pre-jowl sulcus.6

Although primarily utilized for facial volume loss,7-9 CaHA is increasingly being applied to off-face body sites such as the aging hand dorsum10,11 and décolletage12 and enhancing the contour of the upper arm,13-15 abdomen14,15 and thighs.15 In addition to numerous off-label uses, CaHA filler can be safely used together with neuromodulators and energy-based devices.16,17

More recently, CaHA has been used for its neocollagenesis properties. Using multiple, linear subdermal injections of hyperdiluted CaHA (1:2 to 1:6), one investigator demonstrated significant increases in baseline collagen I after 4 and 7 months and increase collagen III levels at 4 months.18 Baseline elastin was also increased after 4 and 7 months. These changes correlated with improvements in skin elasticity, pliability and thickness.

The objective of the following study was to assess the long-term effects of hyperdilute CaHA for improving the appearance of the aging décolleté.

MATERIALS AND METHODS

The study was approved by a centralized Institutional Review Board (Schulman Associates IRB, Inc., Cincinnati, OH) and conducted in accordance with Good Clinical Practices conforming to the ethical guidelines of the 1975 Declaration of Helsinki. Written informed consent was obtained from all participants before participating in any study-related activities.

Participants
Study subjects were healthy adult women who were seeking