Nasolabial fold wrinkles

This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds

The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. The main questions it aims to answer are:
If the products are safe
- Acceptable local tolerance, with acceptable clinical signs after injection.
If the clinical performance is as intended compared to baseline
* Evaluation of performance by assessing the improvement of the appearance of the defect to be corrected by using Global Aesthetic Improvement Scale (GAIS)
* Quantification of the improvement using the appropriate scale when available or other appropriates tool (angle for chin, for instance).
* Pain felt during injection and after injection
* Subject satisfaction