Ada Trindade de Almeida, Lilia Ramos Dos Santos Guadanhim, Ediléia Bagatin, Vivian Barzi Loureiro, Fabiana Wanick, Bruna Felix Bravo, Raquel de Melo Carvalho, Leticia Oba Galvão, Régia Patriota, Graeme Kerson, Shirley Chung, Camila Cazerta de Paula Eduardo
The Brazil HARMONY study provides further support that a combination of HA injectables, biostimulators, and neuromodulators leads to significant improvements in participant satisfaction and psychological and social well-being on validated patient-reported outcome scales.
BACKGROUND: Multimodal facial aesthetic treatment has potential benefits that extend beyond facial enhancements.
OBJECTIVES: The aim of this study was to assess satisfaction with improvement in facial appearance and quantify the psychological, social, and emotional impact of comprehensive, multimodal, full-face aesthetic injectable treatment.
METHODS: In this prospective, open-label, multisite study, participants (n = 64) sequentially received a combination of a hybrid injectable containing hyaluronic acid (HA) plus calcium hydroxyapatite, HA injectables, and onabotulinumtoxinA over 5 months. The primary efficacy endpoint was change in FACE-Q Satisfaction with Facial Appearance Overall scale score. Secondary endpoints included the following assessments: FACE-Q Aging Appraisal, Psychological Function, Social Function, and Satisfaction with Skin; Global Aesthetic Improvement Scale (GAIS); Periorbital Aesthetic Appearance Questionnaire (PAAQ); and participant self-perception of facial age. Outcomes were measured as change in score from baseline to final visit.
RESULTS: Participants demonstrated significant improvement on the FACE-Q Satisfaction with Facial Appearance Overall scale (mean score increase = 46.6; P < .0001). In secondary efficacy analyses, significant improvement was observed on FACE-Q Psychological Function, Social Function, Aging Appraisal, and Satisfaction with Skin scales (P < .0001) and PAAQ (P < .0001). All investigators and participants noted improvement in facial appearance on the GAIS. A majority (85.5%) of participants reported improvement in age-related facial appearance. Most participants documented mild or moderate injection-site reactions (ISRs), and mean ISR durations ranged from 1.0 to 14.5 days.
CONCLUSIONS: The Brazil HARMONY study provides further support that a combination of HA injectables, biostimulators, and neuromodulators leads to significant improvements in participant satisfaction and psychological and social well-being on validated patient-reported outcome scales.