Safety and Efficacy Assessment of a Cross-linked Hyaluronic Acid Dermal Filler for Correction of Moderate-to-Severe Nasolabial Folds in Skin Types III and IV

Abstract

Introduction. Hyaluronic acid fillers are widely used to correct nasolabial folds. This treatment provides favorable aesthetic outcomes. The aim of this study was the safety and efficacy evaluation of Lunaphil Ultra intradermal filler for correcting nasolabial folds in the Iranian population with Fitzpatrick skin types III and IV. Methods. In this before and after clinical study, Lunaphil Ultra dermal filler was injected in nasolabial folds of 24 female and 6 male volunteers (mean age: 43.36 and SD: 11.55). Two independent physicians assessed the severity of nasolabial folds before injection and 2, 12, and 24 weeks later, according to the Allergan scale. The volume, depth, and area of both nasolabial folds and the thickness and density of the dermis in the right nasolabial fold were also measured. Adverse events and subject satisfaction were also recorded. Results. One grade or more improvement was detected in 81%, 57%, and 65% of participants at weeks 2, 12, and 24, respectively. The median score for the Allergan scale decreased significantly in all follow-up visits. The median value of the area of nasolabial folds significantly reduced in all follow-up visits. Two weeks after injection, dermis density showed a significant increase. The mean score for pain level during the injection was 1.96 out of 10. Adverse events were mild and transient. The median satisfaction scores were 9-10 out of 10 at different visits. Conclusion. The findings showed that cross-linked hyaluronic acid dermal filler containing lidocaine could be applied in clinical practice for correction of nasolabial folds in skin types III and IV, with high safety and efficacy. More comprehensive future research could approve these results. This trial is registered with IRCT20150101020514N11.