Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study

May 2022 | Volume 21 | Issue 5 | 481 | Copyright © May 2022


Published online April 22, 2022

Tatjana Pavicic MDa, Gerhard Sattler MDb, Tanja C. Fischer MDc, Thomas Dirschka MDd, Martina Kerscher MDe, Gerd G. Gauglitz MDf, Hanna Dersch g, Maria Kravtsov Msc,g, Iryna Heide MDg, Welf Prager MDh

aPrivate Practice Private for Dermatology and Aesthetics, Munich, Germany
bRosenpark Research, Darmstadt, Germany
cSkin and Laser Centre, Potsdam, Germany
dCentroderm GmbH, Wuppertal, Germany
eUniversity of Hamburg, Hamburg, Germany
fHaut- und Laserzentrum im Glockenbachviertel, Munich, Germany
gMerz Pharmaceuticals GmbH, Frankfurt am Main, Germany
hPrager & Partner Dermatologische Praxis, Hamburg, Germany

Abstract
Background: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks.
Methods: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting.
Results: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity.
Conclusion: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months.

J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737

INTRODUCTION

The introduction of soft tissue augmentation with injectable dermal fillers has revolutionized the aesthetics market and is now an eminent routine procedure. An array of filler products is currently available to attenuate signs of facial aging and improve aesthetic disharmonies, eventually contributing to a better quality of life.

Calcium hydroxylapatite with 0.3% integral lidocaine (CaHA(+), Radiesse® (+), Merz North America, Inc, Raleigh, NC) was developed from Radiesse®, a product with a well-established safety and performance profile renowned for its ability to induce neocollagenesis and yield long-lasting aesthetic results.1

Pre-incorporated lidocaine in the CaHA formulation effectively reduces pain during injection without impacting the safety and performance of the product.2,3

CaHA’s versatility makes it suitable for most aspects of facial rejuvenation, such as line filling, skin tightening, lifting, contouring, and volumizing.3 Although it is common practice to treat several facial areas in one session, few clinical data on this holistic treatment approach are available. This study aimed to confirm safety and effectiveness of CaHA(+) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks during the same session.