Abstract
Introduction: Excess fat in the submental area (FSA) is associated with a negative impact on facial harmony and self-perception, often leading to decreased patient satisfaction with appearance and increased demand for aesthetic interventions Methods: in this prospective, multicentric, cohort study Pbserum HA 1.5 Medium, a combined enzymatic therapy (collagenases G/H PB220, lyase PB72K, lipase PB500), together with non cross-linked high molecular weight hyaluronic acid (HMW-HA)), was used for treating FSA in healthy adults according to a recommended protocol. Primary efficacy outcome was the variation of FSA in every visit, quantified by a scale ranging from 0 (no localized FSA) to 4 (extreme submental convexity). Patient-reported outcomes were also considered. Results: 33 patients (median age: 44; range 21-72; 79% females) were evaluated at visit 1; 87.8% completed the study. At baseline, excess FSA scored ≤ 2 was present in 53.3% of patients. After two treatment sessions, proportion increased to 75.8%. Proportion of patients with an FSA score of 4 was reduced from 26.67% to 6.9%. FSA scale was significantly reduced from baseline to final visit (p<0.05). Regarding safety, 36 % of the patients reported adverse effects, which included itching (23%), pain (23%), edema (15%), isolated rash (8%), dysphonia (8%) and discomfort (8%).
Conclusions: Pbserum HA 1.5 Medium was associated with significant reduction of excess FSA in a three-week period, favorable patient-reported outcomes and a good tolerability profile.
Keywords