Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.