Evaluation of Clinical Safety and Effectiveness of Hyaluronic Acid-based Temporary Dermal Filler Used in Nasolabial Folds

Abstract

Basis: Hyaluronic acid-based temporary dermal filler are used in the treatment of facial folds and wrinkles. Objectives: Evaluate the effectiveness and safety of Rennova®, a hyaluronic acid-based filler used in nasolabial folds. Methods: An open label, single-center, phase IV, prospective, observational clinical study, with duration of 360 days, totaling 11 visits. The study included 30 female volunteers, between 30 and 60 years of age, presenting nasolabial folds classified as 3 and 4 according to the Wrinkle Severity Rating Scale and skin phototypes I to V, according to the classification of Fitzpatrick. The effectiveness was subjectively evaluated using the wrinkle severity scale and the Global Aesthetic Improvement Scale and objectively analyzed suing photographs and biopsies. The volunteers gave their opinions about the procedure and results in a questionnaire. The safety was evaluated by observing adverse events; pain, discomfort and local sensitivity; tolerability and biopsies. Results: In the beginning of the study, 76% of the volunteers presented moderate wrinkles and 24% severity. At the end, 8% presented severe, 56% moderate and 36% mild wrinkles. The adverse events with positive causal nexus were: local erythema/edema, ecchymosis, hematoma and local pain. They presented mild to moderate intensity, short to medium duration. Conclusions: In relation to the wrinkle severity rating scale and global aesthetic improvement scale, the results were satisfactory (p<0.05). The adverse events with positive causal nexus were temporary and the biopsy did not show any inflammatory process, which demonstrates the product safety.