Efficacy and Safety of a Proposed Hyaluronic Acid (Lunaphil Ultra) Compared to the Reference Product (Juvéderm Ultra 4) for the Management of Moderate or Severe Nasolabial Folds: A Randomized, Double-Masked, Within-Subject, Equivalency-Controlled Trial.

Abstract

Nasolabial folds (NLFs) are a natural alteration that become more noticeable with aging and dramatically affect facial skin beauty. Hyaluronic acid (HA) dermal fillers are frequently utilized to correct these visible signs of aging. The objective of this study was to evaluate and compare the effectiveness and safety of Lunaphil Ultra vs Juvéderm Ultra 4 in the treatment of NLFs. Each participant received Lunaphil Ultra and Juvéderm Ultra 4 in 1 of their NLFs. For each participant the products were injected at the first visit, and if needed an additional injection (touch-up) was done at the second visit. The duration of the study was 24 weeks for each participant. The primary outcome of this study was to assess the mean level of NLF severity score improvement compared to baseline with the Wrinkle Severity Rating Scale (WSRS) at Week 24. The mean ± SD level of improvement by WSRS was -0.80 ± 0.66 for Lunaphil Ultra and -0.81 ± 0.67 for the Juvéderm Ultra 4 group (P value > .99). The difference between the 2 groups was within the predefined equivalency margin of ± 0.17. Of the treated NLFs, 71.15% in the Lunaphil Ultra group and 66.35% in the Juvéderm Ultra 4 group received a touch-up injection (P value = .33). As indicated by the study results, Lunaphil Ultra had an acceptable efficacy and safety profile in the Iranian population and was equivalent to Juvéderm Ultra 4 in WSRS improvement.