Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour

November 2021 | Volume 20 | Issue 11 | 1231 | Copyright © November 2021


doi:10.36849/JDD.6442

Amir Moradi MDa, Jeremy B. Green MDb, Joel L. Cohen MDc, John H. Joseph MDd, Rada Dakovic PhDe, Gemma Odena PhDf, Amit Verma PhDf, Richard Scher MDf

aMoradi MD, Vista, CA
bSkin Research Institute and Skin Associates of South Florida, Coral Gables, FL
cAboutSkin Dermatology and AboutSkin Research Greenwood Village and Lone Tree, CO; Department of Dermatology, University of California, Irvine, CA
dClinical Testing Center of Beverly Hills, Encino, CA
eMerz Pharmaceuticals GmbH, Frankfurt am Main, Germany
fMerz North America, Inc., Raleigh, NC

Abstract
Background: One of the early signs of aging is loss of jawline contour. Not all cases require surgical intervention and soft-tissue augmentation with injectable fillers may restore the profile and youthful appearance of the jawline.
Objective: To demonstrate the effectiveness and safety of calcium hydroxylapatite with lidocaine [CaHA (+); Radiesse (+)] to improve the contour of jawline after deep (subdermal and/or supraperiosteal) injection.
Methods: Healthy eligible patients with moderate or severe ratings on the Merz Jawline Assessment Scale (MJAS) were randomized 2:1 to treatment with CaHA (+) or to control. Patients in the control group remained untreated until week 12, then received delayed treatment. Touch-ups were allowed in both groups, and re-treatment was allowed in the treatment group only. Effectiveness was evaluated on the MJAS, patient and investigator Global Aesthetic Improvement Scales, and FACE-Q questionnaires. Adverse events were recorded over a 60-week period.
Results: Treatment response rate (1-point or greater MJAS improvement) was 93/123 (75.6%) for the treatment group and 5/57 (8.8%) for the control/delayed-treatment group at week 12. The difference between response rates was statistically significant (P<0.0001), showing superiority of treatment over control. Satisfaction with aesthetic improvement was reported by patients and treating investigators throughout the study. A total of 76/113 (67.3%) patients who responded to treatment 12 weeks after initial injection also demonstrated persistent improvement 48 weeks after initial treatment. The study demonstrated a favorable safety profile, with no reported unexpected adverse events.
Conclusions: CaHA (+) is a safe and effective treatment for improving the contour of the jawline.

J Drugs Dermatol. 2021;20(11): 1231-1238. doi:10.36849/JDD.6442

INTRODUCTION

Multiple factors, including hereditary and aging aspects, lead to a noticeable, undesirable contour of the jawline, such as loss of bone volume, fat atrophy (volume loss), and descent of fat.1 Volume loss in relation to the attachment points of the skin to the underlying superficial muscular aponeurotic system and/or bone results in specific patterns of deflation, pseudoptosis, and shadowing -- all of which characterize the aging face. As soft tissue fullness shifts from the upper face to the lower face, the aging face changes from a youthful heart-shaped appearance to a more rectangular shape.2 A surgical facelift is the standard treatment used to address these signs of aging and aids in redefining the jawline. As the aesthetic market evolves, patients are increasingly seeking to enhance their appearance with less invasive procedures and reduced downtime.3

Soft tissue fillers may be injected to replenish volume and restore the contour of the jawline; fillers also provide an opportunity to enhance the prominence of the jaw by adding volume at the chin and/or on the sides of the jawline. This enhancement can be achieved through filling volume and contour deficits, repositioning of ptotic, superficial fat compartments, and tightening the skin around the jawline.3,4 To reestablish or correct optimal jawline contour, a soft tissue filler with high elasticity and viscosity offers the best volumizing capacity.2

Over the last decade, multiple published reports have demonstrated that fillers, such as calcium hydroxylapatite (CaHA; Radiesse, Merz North America, Raleigh, NC, USA) improve the appearance of the aging jawline.4-11 The available
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