DISCUSSION
CaHA (+) demonstrated clinically and statistically significant sustained improvements in the contour of the jawline. This objective measure was further supported by multiple patient and investigator-reported endpoints demonstrating aesthetic improvements following treatment.
The study population, which included male and female patients of various ages and races and all Fitzpatrick skin types, was representative of the diverse group of patients that typically receive aesthetic treatments in the facial region.13
Overall, the injection volumes utilized led to the desired aesthetic outcome and were in line with standard clinical practice.4,12,14,15
At week 12, responder rates were calculated according to the MJAS as assessed by a blinded rater. Treatment response was defined as a 1-point or greater improvement on both jawlines compared to baseline; this metric of improvement is a common criterion for aesthetic-medicine clinical trials, indicating demonstration of clinically relevant results.16-20 The treatment response rate for the CaHA (+) group was 75.6%, exceeding the targeted margin of 50% (P<0.0001). In contrast, 8.8% of patients in the untreated control group were assessed as responders at week 12. The difference between the response rates in the treated and untreated groups at week 12 was statistically significant (66.8%, P<0.0001). Overall, comparable results were observed when stratifying results by Fitzpatrick skin type categories (I-III vs IV-VI) and sex (females vs males).
These findings demonstrate that CaHA (+) is an effective treatment for improving the contour of the jawline area. All patients categorized as responders at week 12 were assessed for duration of treatment effectiveness with the majority of patients demonstrating retention of treatment response at 48 weeks. Additionally, a small subset of patients who did not receive re-treatment retained treatment response up to 60 weeks posttreatment.
All results from the secondary endpoints related to patient- and investigator-reported assessments (eg, FACE-Q Satisfaction with Lower Face and Jawline and investigator and patient GAIS) successfully support the primary endpoint indicating that CaHA (+) is an effective treatment for improving contour of the jawline area.
Overall, study findings indicate improvements reported by investigators and patients 12 weeks after treatment with CaHA (+) (ie, when patients were expected to experience maximum treatment benefit), and additionally support the sustained effect of CaHA (+) treatment for up to 48 weeks when injected in the jawline.
This CaHA (+) pivotal study demonstrated a favorable safety profile, with no treatment-related SAEs and no unexpected or atypical events reported. Treatment-related adverse events consisted primarily of administration site conditions, were generally mild to moderate in intensity, lasted for less than 15 days, and mainly resolved prior to study end. Findings from the patient's CTR diary were in line with expectations for injection procedures with dermal fillers in the face and the expected safety profile of CaHA (+) from a patient self-reporting perspective.16-20 In general, safety findings were similar in incidence, severity, and duration when stratified by Fitzpatrick skin type categories (I-III vs IV-VI) and sex (females vs males). These findings demonstrate that injected CaHA (+) is a safe and well-tolerated treatment option to improve jawline contour.
The study population, which included male and female patients of various ages and races and all Fitzpatrick skin types, was representative of the diverse group of patients that typically receive aesthetic treatments in the facial region.13
Overall, the injection volumes utilized led to the desired aesthetic outcome and were in line with standard clinical practice.4,12,14,15
At week 12, responder rates were calculated according to the MJAS as assessed by a blinded rater. Treatment response was defined as a 1-point or greater improvement on both jawlines compared to baseline; this metric of improvement is a common criterion for aesthetic-medicine clinical trials, indicating demonstration of clinically relevant results.16-20 The treatment response rate for the CaHA (+) group was 75.6%, exceeding the targeted margin of 50% (P<0.0001). In contrast, 8.8% of patients in the untreated control group were assessed as responders at week 12. The difference between the response rates in the treated and untreated groups at week 12 was statistically significant (66.8%, P<0.0001). Overall, comparable results were observed when stratifying results by Fitzpatrick skin type categories (I-III vs IV-VI) and sex (females vs males).
These findings demonstrate that CaHA (+) is an effective treatment for improving the contour of the jawline area. All patients categorized as responders at week 12 were assessed for duration of treatment effectiveness with the majority of patients demonstrating retention of treatment response at 48 weeks. Additionally, a small subset of patients who did not receive re-treatment retained treatment response up to 60 weeks posttreatment.
All results from the secondary endpoints related to patient- and investigator-reported assessments (eg, FACE-Q Satisfaction with Lower Face and Jawline and investigator and patient GAIS) successfully support the primary endpoint indicating that CaHA (+) is an effective treatment for improving contour of the jawline area.
Overall, study findings indicate improvements reported by investigators and patients 12 weeks after treatment with CaHA (+) (ie, when patients were expected to experience maximum treatment benefit), and additionally support the sustained effect of CaHA (+) treatment for up to 48 weeks when injected in the jawline.
This CaHA (+) pivotal study demonstrated a favorable safety profile, with no treatment-related SAEs and no unexpected or atypical events reported. Treatment-related adverse events consisted primarily of administration site conditions, were generally mild to moderate in intensity, lasted for less than 15 days, and mainly resolved prior to study end. Findings from the patient's CTR diary were in line with expectations for injection procedures with dermal fillers in the face and the expected safety profile of CaHA (+) from a patient self-reporting perspective.16-20 In general, safety findings were similar in incidence, severity, and duration when stratified by Fitzpatrick skin type categories (I-III vs IV-VI) and sex (females vs males). These findings demonstrate that injected CaHA (+) is a safe and well-tolerated treatment option to improve jawline contour.
CONCLUSION
These study findings demonstrate that CaHA (+) is a safe and
effective treatment for improving moderate to severe loss of
jawline contour and have substantiated its FDA-approval for this
indication.
DISCLOSURES
This research was supported and funded by Merz North America, Inc.
Dr. Cohen has served as a consultant, clinical investigator, and member of the Global Key Opinion Leader Network for Merz Aesthetics. Dr. Green is a consultant, clinical investigator, and speaker for Merz Aesthetics. Dr. Scher, Dr. Verma, and Dr. Odena are employees of Merz North America, Inc. Dr. Dakovic is an employee of Merz Pharmaceuticals GmbH.
Dr. Cohen has served as a consultant, clinical investigator, and member of the Global Key Opinion Leader Network for Merz Aesthetics. Dr. Green is a consultant, clinical investigator, and speaker for Merz Aesthetics. Dr. Scher, Dr. Verma, and Dr. Odena are employees of Merz North America, Inc. Dr. Dakovic is an employee of Merz Pharmaceuticals GmbH.
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3. Pavicic T, Few JW, Huber-Vorlander J. A novel, multistep, combination facial rejuvenation procedure for treatment of the whole face with incobotulinumtoxinA, and two dermal fillers- calcium hydroxylapatite and a monophasic, polydensified hyaluronic acid filler. J Drugs Dermatol. 2013;12(9):978-84.
4. Dallara JM, Baspeyras M, Bui P, et al. Calcium hydroxylapatite for jawline rejuvenation: consensus recommendations. J Cosmet Dermatol. 2014;13(1):3-14.
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9. Bartus CL, Sattler G, Hanke CW. The tower technique: a novel technique for the injection of hyaluronic acid fillers. J Drugs Dermatol. 2011;10(11):1277-80.
10. Braz A, Humphrey S, Weinkle S, et al. Lower face: clinical anatomy and regional approaches with injectable fillers. Plast Reconstr Surg. 2015;136(5 Suppl):235S-57S.
11. Buckingham ED, Glasgold R, Kontis T, et al. Volume rejuvenation of the facial upper third. Facial Plast Surg. 2015;31(1):43-54.
2. Lorenc ZP, Lee JC. Composite volumization of the aging face: supraperiosteal space as the foundation for optimal facial rejuvenation. J Drugs Dermatol. 2016;15(9):1136-41.
3. Pavicic T, Few JW, Huber-Vorlander J. A novel, multistep, combination facial rejuvenation procedure for treatment of the whole face with incobotulinumtoxinA, and two dermal fillers- calcium hydroxylapatite and a monophasic, polydensified hyaluronic acid filler. J Drugs Dermatol. 2013;12(9):978-84.
4. Dallara JM, Baspeyras M, Bui P, et al. Calcium hydroxylapatite for jawline rejuvenation: consensus recommendations. J Cosmet Dermatol. 2014;13(1):3-14.
5. Sclafani AP, Kwak E. Alternative management of the aging jawline and neck. Facial Plast Surg. 2005;21(1):47-54.
6. Graivier MH, Bass LS, Busso M, et al. Calcium hydroxylapatite (Radiesse) for correction of the mid- and lower face: consensus recommendations. Plast Reconstr Surg. 2007;120(6 Suppl):55s-66s.
7. Dayan SH, Lieberman E, Larimer K. High-volume calcium hydroxylapatite filler to the lower one-third of the face. Arch Facial Plast Surg. 2009;11(2):145-7.
8. Hamilton D. Calcium Hydroxylapatite for Augmentation of the Posterior Mandibular Angle in Men. Cosmetic Dermatology. 2009;22(9):474-78.
9. Bartus CL, Sattler G, Hanke CW. The tower technique: a novel technique for the injection of hyaluronic acid fillers. J Drugs Dermatol. 2011;10(11):1277-80.
10. Braz A, Humphrey S, Weinkle S, et al. Lower face: clinical anatomy and regional approaches with injectable fillers. Plast Reconstr Surg. 2015;136(5 Suppl):235S-57S.
11. Buckingham ED, Glasgold R, Kontis T, et al. Volume rejuvenation of the facial upper third. Facial Plast Surg. 2015;31(1):43-54.
