Efficacy and Safety of Monophasic Versus Biphasic Hyaluronic Acid Dermal Fillers in Correction of Moderate-to-Severe Nasolabial Folds: A Randomized, Controlled, Double Blinded and Intraindividual Study
摘要
Facial aging leads to volume loss, especially in the midface, resulting in deeper nasolabial folds (NLFs). Hyaluronic acid (HA) fillers are widely used for correction, with monophasic and biphasic formulations differing in structure and rheology. However, comparative studies between them are limited.
AimTo compare the efficacy and safety of monophasic and biphasic fillers in treating moderate-to-severe NLFs using WSRS, GAIS, PROM, and VAS scores.
ObjectivesThe objective of this study was to evaluate and compare the outcomes using following parameters: (i) Efficacy using Wrinkle Severity Rating Scale (WSRS), (ii) Aesthetic improvement using Global Aesthetic Improvement Scale (GAIS), (iii) Patient satisfaction using a 5-grade Ad hoc PROM scale, (iv) Pain assessment using Visual Analog Scale (VAS).
MethodsA randomized, controlled, double-blinded, intra-individual study was conducted on 11 patients (22 NLF sites). Each patient received both types of fillers—one on each side. Assessments were done at 12, 24, and 36 weeks by the treating investigator, a blinded live evaluator, and the patient.
ResultsAt 12 and 24 weeks, both fillers showed similar improvements. By 36 weeks, monophasic fillers demonstrated significantly better wrinkle reduction, aesthetic outcomes, and higher patient satisfaction. Pain scores were also significantly lower with monophasic fillers, indicating better tolerability.
ConclusionMonophasic fillers provide better long-term efficacy, patient satisfaction, and comfort compared to biphasic fillers for the treatment of moderate-to-severe nasolabial folds.