1. Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour.
- Author
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Moradi A and Dakovic R
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Anesthetics, Local administration & dosage, Clinical Studies as Topic, Dermal Fillers administration & dosage, Jaw drug effects, Treatment Outcome, Cosmetic Techniques, Durapatite administration & dosage, Lidocaine administration & dosage, Patient Satisfaction, Skin Aging drug effects
- Abstract
Summary What is this article about? A study (ClinicalTrials.gov identifier: NCT03583359) that tested whether an injectable filler treatment called calcium hydroxylapatite with lidocaine, or CaHA (+), could improve the shape of the jawline. How was the study in this summary conducted? Loss of jawline shape is a change to jawline appearance, like sagging or deflating, that occurs as people get older. A total of 123 participants received CaHA (+) injections on day 1 of the study (immediate treatment). Fifty-seven participants did not receive CaHA (+) until week 12 (delayed treatment). Jawline shape at week 12 was rated on a five-point scale (0 = no loss of shape or volume; 4 = extreme loss). Researchers also looked at participants' satisfaction and self-reported improvement, ratings of how old participants thought they looked, and side effects. What were the results of the study? In the immediate treatment group, 76% of participants had improvement in jawline shape at week 12 (compared with 9% of participants in the delayed treatment group), which typically lasted approximately 8 months, and 94% self-reported improvement in jawline appearance. The participants were more satisfied with their jawlines and reported looking approximately 3 years younger at week 12 compared with before treatment. Regardless of sex or skin tone, side effects were categorized as mostly mild or moderate reactions, like lumps or bruising, at the site where CaHA (+) was injected. What do the results of this study mean? The results showed that CaHA (+) injections improved jawline shape in most participants and caused only mild or moderate side effects regardless of sex or skin tone, suggesting that CaHA (+) is safe and works well for diverse groups of patients. Who should read this article? This summary is for patients and others interested in learning about how CaHA (+) works, its safety, and its ability to improve jawline shape. Who sponsored this study? The study was sponsored by Merz North America, Inc.
- Published
- 2024
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