Hsin-Kai Chen, Hsi-Cheng Liu, Heng-Ju Lin, Donghui Wu
The investigational formulation demonstrated favorable short-term tolerability and early aesthetic improvement in an uncontrolled pilot setting. These findings do not establish comparative effectiveness, long-term durability, tissue integration, or long-term biocompatibility. Controlled studies with extended follow-up are required.
BACKGROUND: Nonsurgical rhinoplasty using hyaluronic acid fillers provides minimally invasive correction of selected nasal contour irregularities. Hybrid formulations incorporating biodegradable polymeric microspheres have been developed to provide immediate volumetric correction together with additional structural support; however, clinical evidence regarding these formulations remains limited.
OBJECTIVE: To evaluate the short-term safety, tolerability, preliminary aesthetic effectiveness, and patient satisfaction associated with an investigational hybrid filler containing cross-linked hyaluronic acid, polycaprolactone, and polylactic acid microspheres.
METHODS: This prospective, single-center, uncontrolled pilot study included 150 adults undergoing nonsurgical rhinoplasty. Participants were assessed at baseline, Day 2, Week 2, Month 1, and Month 3. Outcomes included treatment-emergent adverse events, Global Aesthetic Improvement Scale ratings, patient satisfaction, nasal tip projection, dorsal height, and procedural characteristics.
RESULTS: Improved or Very Improved GAIS ratings were observed in 86.7% of participants at Month 1 and 83.3% at Month 3. Satisfaction scores of 4-5 were reported by 90.0% at Month 1 and 86.7% at Month 3. Tip projection increased by more than 1.5 mm in 70.0%, while dorsal height increased by more than 2.0 mm in 63.3%. Mild events included transient erythema in 3.3%, minor bruising in 13.3%, and injection-site pain with a VAS score greater than 5 in 10.0%. No serious or treatment-requiring adverse event, vascular compromise, skin necrosis, visual disturbance, infection, granuloma, delayed inflammatory reaction, or filler migration was observed during three months of follow-up.
CONCLUSION: The investigational formulation demonstrated favorable short-term tolerability and early aesthetic improvement in an uncontrolled pilot setting. These findings do not establish comparative effectiveness, long-term durability, tissue integration, or long-term biocompatibility. Controlled studies with extended follow-up are required.