Validation of a Midfacial Scale and Its Use in a Randomized, Evaluator-Blinded Study of CPM-HA-V

January 2024 | Volume 23 | Issue 1 | 1284 | Copyright © January 2024


Published online December 16, 2023

doi:10.36849/JDD.7981

Amir Moradi MDa, Jason D. Bloom MDb, Amit Verma DrPH MPHc, Ashlee W. Duncan MS PhDd

aMoradi MD, Vista, CA
bBloom Facial Plastic Surgery, Bryn Mawr, PA
cFormerly Global Clinical Development, Merz North America, Raleigh, NC, Currently ABK Biomedical, Halifax, NS, Canada
dGlobal Clinical R&D, Merz North America, Raleigh, NC

Abstract
Background: Age-related loss of midfacial contour is frequently corrected using dermal fillers. A validated photonumeric scale is beneficial when evaluating post-treatment aesthetic improvement.
Objective: To present scale-development activities for the Merz Cheek Fullness Assessment Scale (MCFAS) and report pilot-study results of a hyaluronic-acid filler (Belotero Volume with Lidocaine; CPM-HA-V) to treat midfacial volume loss.
Methods: A 5-point photonumeric scale was developed to objectively assess midface volume loss. Rater reliability was evaluated using live assessments. The clinical relevance of a 1-point difference in severity grade was evaluated using photographic comparisons. Pilot-study participants, with moderate-to-severe volume loss on the MCFAS, were randomized 2:1 to treatment or untreated control. Effectiveness was evaluated using the MCFAS, and adverse events were recorded.
Results: The MCFAS demonstrated substantial intra- and interrater agreement among physicians (weighted kappa > 0.6). The mean absolute difference (95% confidence interval) in scale ratings was 1.12 (1.00, 1.24) for photographic pairs differing by one grade and was 0.55 (0.48, 0.63) for pairs of the same grade, suggesting a 1-point difference is clinically relevant. In the pilot study, significant  (P < 0.0001) differences were observed in MCFAS response rates between treatment and control. No safety concerns were identified.
Conclusion: The MCFAS is a validated, reliable, and clinically relevant photonumeric scale for rating midfacial volume loss in males and females of various ages and skin types. In a pilot study, CPM-HA-V was found to be safe and tolerable, and the MCFAS was able to detect clinically meaningful post-treatment changes.

J Drugs Dermatol. 2024;23(1):1284-1291.     doi:10.36849/JDD.7981

INTRODUCTION

Primary markers of facial aging include a noticeable, and often undesirable, lack of midfacial contour, generally characterized by a loss of cheek volume and a shift in soft tissue fullness from the midface to the lower facial regions.1-3 Loss of volume and the ligamentous attachments of skin to bone results in specific patterns of deflation, ptosis, and shadowing, resulting in a heavier, rectangular-shaped face, rather than the preferred youthful, heart-shaped face.3

Minimally invasive treatments, including dermal fillers, are often used to reestablish cheek volume and contour. To demonstrate treatment effectiveness, regulatory agencies often require meaningful and measurable treatment-related improvements from baseline using scientifically valid photonumeric scales.

Consistent with other facial aesthetic scales intended for use in clinical trials,4-11 the current work describes the validation of the Merz Cheek Fullness Assessment Scale (MCFAS) and establishes that a 1-point difference in scale-severity grade is clinically relevant. Furthermore, this manuscript presents the results of a pilot study in which a Cohesive Polydensified Matrix (CPM) hyaluronic-acid filler (Belotero Volume with Lidocaine; CPM-HA-V) was used for volume augmentation in the midface. The safety and effectiveness of CPM-HA-V, as well as the MCFAS's ability to detect clinically relevant post-treatment changes, are reported.

MATERIALS AND METHODS

The following subsections outline the: (1) MCFAS development, reliability, and clinical relevance and (2) design and analysis of a pilot study assessing the safety and effectiveness of CPM-HA-V and the ability of the MCFAS to detect clinically relevant post-treatment changes.

MCFAS Development
Development and layout of the MCFAS was similar to other published facial aesthetic scales.4-6 Figure 1 describes the overall 
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