Study Evaluating the Safety and Effectiveness of AnGelHA 2 Filler for Treating Moderate to Severe Wrinkles and Facial Contour Remodeling in Routine Practice

What this Trial Is About

Researchers are evaluating the performance and safety of AnGelHA 2 filler for correcting moderate to severe wrinkles and folds and for facial contour remodeling in regular clinical practice. This post-market, prospective, non-interventional, open-label study includes adults over 18 years who choose to undergo non-surgical aesthetic procedures using AnGelHA 2. The study aims to observe how this filler works in routine use without changing standard treatment methods. Participants will receive at least one injection of AnGelHA 2, with their healthcare provider deciding the injection technique, volume, depth, and treated areas based on individual needs. Treatments can address a single area or multiple areas and may be repeated anytime during the study as part of normal care. The study does not interfere with how treatments are given and follows patients through their usual clinical visits. The study involves an initial visit at baseline and optional follow-up visits at 1, 3, 6, 9, and 12 months after treatment. Additional visits can occur if requested by the patient or deemed necessary. At each visit, safety will be assessed along with how well the treatment performs by evaluating each treated area and overall facial appearance. The main outcome measured is the number of participants who show improvement in the investigators Global Aesthetic Improvement Scale iGAIS up to 56 weeks after treatment.

Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2