2014 Wiley Periodicals, Inc.
Adele Sparavigna, MD,1 Pasquale Fino, MD,2 Beatrice Tenconi, Sc.D,1 Nicola Giordan, PharmD,3 Vittoria Amorosi, MD,2 & Nicol!o Scuderi, MD2
1Derming Clinical Research and Bioengineering Institute, Monza, MB, Italy
2Department of Plastic, Reconstructive and Aesthetic Surgery, University of Rome ’Sapienza’, Policlinico ’Umberto I’, Rome, Italy
3Clinical Research Department, Fidia Farmaceutici, Abano Terme, Padua, Italy
Background A novel Hyaluronic Acid (HA) derivative dermal filler has been developed with characteristics especially suited for nasolabial folds (NLF) and facial defects due to volume loss.
Aims An open-label prospective study was carried out to evaluate this HA filler’s performance in correcting facial defects due to volume loss.
Methods A single Italian site treated subjects aged 30–65 for facial defects due to volume loss with a new dermal filler injectable gel; subjects returned to the clinic at 7 and 14 days, and 1, 3, 6, 9, and 12 months for follow-up. The primary effectiveness endpoint was improvement in wrinkle severity (measured using the Wrinkle Severity Rating Scale) (WSRS) and facial volume (measured using the Facial Volume Loss Scale) (FVLS) at 6 and 12 months from baseline. Secondary endpoints were safety evaluation, performance duration, product handling, subjects’ and investigator’s treatment evaluation. Assessment of aesthetic results included the skin
hydration, image analysis of nasolabial folds (3D), and photographic documentation.
Results The reduction in nasolabial wrinkles was statistically significant at 6 months after the first implant. The aesthetic improvement of 1 grade on WSRS was evident in 95% of subjects up to 3 months, in 84% of subjects up to 6 months and in 27% up to 12 months. A clinically (> 1 point improvement) and statistically significant improvement in the FVLS was observed at each study visit; in 100% of treated cases, up to 3 months and in 61% up to 9 months. Good results were obtained during the study in skin hydration. There were no severe adverse events related to treatment.
Conclusion This injectable gel is well tolerated and has been demonstrated to provide a smooth and natural improvement in facial defects due to volume loss in nasolabial folds and the malar region that lasts for up to 1 year.