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.

IF 3 2区医学 Q1 SURGERY

Aesthetic Surgery Journal Pub Date : 2025-08-05 DOI:10.1093/asj/sjaf156

Kamran Jazayeri, Omid Zargari, Hoshyar Gholami, Araz Sabzvari, Hamidreza Kafi, Kamran Balighi

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引用次数: 0

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

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一种推荐的透明质酸（Lunaphil Ultra）与参考产品（juv Ultra 4）治疗中度或重度鼻唇褶皱的疗效和安全性：一项随机、双盲、受试者内、等效对照试验

背景：鼻唇褶皱是一种自然变化，随着年龄的增长而变得更加明显，并显著影响面部皮肤美观。透明质酸（HA）真皮填充物经常被用来纠正这些可见的衰老迹象。目的：本研究的目的是评价和比较Lunaphil Ultra和juv derm Ultra 4治疗NLFs的有效性和安全性。方法：每个参与者在1例NLFs中接受Lunaphil Ultra和juv Ultra 4。对于每个参与者，产品在第一次访问时注射，如果需要，在第二次访问时进行额外的注射（补片）。每个参与者的研究持续时间为24周。本研究的主要结果是在第24周用皱纹严重程度评定量表（WSRS）评估NLF严重程度评分与基线相比改善的平均水平。结果：经WSRS治疗后，Lunaphil Ultra组的平均±SD改善水平为-0.80±0.66,juv derm Ultra 4组的平均±SD改善水平为-0.81±0.67 （P值为bb0.99）。两组之间的差异在预定的等效范围内±0.17。在治疗的NLFs中，Lunaphil Ultra组71.15%和juvsamuderm Ultra 4组66.35%接受补注（P值= 0.33）。结论：研究结果表明，Lunaphil Ultra在伊朗人群中具有可接受的疗效和安全性，在WSRS改善方面与juv Ultra 4相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Aesthetic Surgery Journal SURGERY-

CiteScore

6.20

自引率

20.70%

发文量

309

审稿时长

6-12 weeks

期刊介绍： Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.