Cartier Hugues, Deutsch Jean-Jacques, Braccini Frederic, Garcia Philippe, Ehlinger Agnès, David Michel, Loreto Frederic, Benadiba Laurent, Grand-Vincent Anne, Mathey Elena Rumyantseva, Nadra Karim, Fanian Ferial
Centre Médical Saint Jean, Arras, France.
Private Practice, Paris, France.
J Cosmet Dermatol. 2025 Jan;24(1):e16565. doi: 10.1111/jocd.16565. Epub 2024 Dec 20.
The function of injectable hyaluronic acid-based fillers is to smooth dermal wrinkles formed during aging. The aim of this study is to evaluate the performance and safety of a dermal filler after its commercialization.
In this context, an 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Fine Lines (AFFL) was performed on the forehead, the upper lip, the cheek folds, and the crow's feet. The efficacy, the longevity, and the safety were evaluated after a single filler injection without any re-touch injection. The persistence of the correction was evaluated at 3, 6, 9, 12, 15, and 18 months.
The observations performed on 196 subjects enrolled showed that AFFL injections induced a significant improvement in wrinkle correction for all the assessed areas. These effects were significant as soon as 3 weeks after injection and remained significant until 18 months. Furthermore, injections of AFFL were well tolerated and no severe event was recorded. The minor reported reactions were resolved within 3 weeks.
AFFL with Tri-Hyal technology is suitable and well tolerated for the treatment of superficial wrinkles without any irregularity or Tyndall effect and showed a prolonged efficacy for at least 18 months.
注射用透明质酸类填充剂的作用是抚平衰老过程中形成的皮肤皱纹。本研究的目的是评估一种皮肤填充剂商业化后的性能和安全性。
在此背景下,对196名受试者的前额、上唇、脸颊皱纹和鱼尾纹进行了一项为期18个月的前瞻性随机单盲研究,以评估ART FILLER细纹填充剂(AFFL)的疗效和安全性。在单次填充剂注射后,无需任何补打,评估其疗效、持久性和安全性。在3、6、9、12、15和18个月时评估矫正效果的持久性。
对196名受试者的观察表明,AFFL注射对所有评估区域的皱纹矫正均有显著改善。这些效果在注射后3周时即很显著,并一直持续到18个月。此外,AFFL注射耐受性良好,未记录到严重事件。报告的轻微反应在3周内得到缓解。
采用三重透明质酸技术的AFFL适用于治疗浅表皱纹,耐受性良好,无任何不规则现象或丁达尔效应,且疗效至少持续18个月。