1. Long-term duration and safety of Radiesse (+) for the treatment of jawline.
- Author
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Green JB, Del Campo R, Durkin AJ, Funt DK, Nasrallah N, Martinez K, and Moradi A
- Subjects
- Humans, Female, Middle Aged, Adult, Male, Follow-Up Studies, Treatment Outcome, Time Factors, Dermal Fillers administration & dosage, Dermal Fillers adverse effects, Single-Blind Method, Esthetics, Patient Satisfaction, Face, Aged, Durapatite administration & dosage, Durapatite adverse effects, Cosmetic Techniques adverse effects, Skin Aging drug effects, Carboxymethylcellulose Sodium administration & dosage, Carboxymethylcellulose Sodium adverse effects
- Abstract
Background: Calcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment., Methods: Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group., Results: Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild., Conclusions: CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks., Trial Registration: ClinicalTrials.gov Identifier: NCT03583359., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)
- Published
- 2024
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