Clinical Study of the Bridging Technique Using AILEENE Vol. 2 Filler to Improve Smile Lines in Adults Aged 30 to 65

What this Trial Is About

This clinical trial is designed to evaluate the Bridging Technique for treating nasolabial folds, commonly known as smile lines, in adults aged 30 to 65 years. The study aims to determine whether this new method, which uses very small amounts of hyaluronic acid HA dermal filler placed in thin horizontal threads under the folds, can safely improve their appearance and satisfy patients. The Bridging Technique was developed to provide natural-looking results with less product and reduced risk compared to traditional filler methods. Participants will receive a single treatment with AILEENE Vol. 2 HA dermal filler applied using the Bridging Technique to both nasolabial folds. The total filler used will not exceed 1.0 ml across both sides. An optional top-up treatment may be given at Week 2 or Week 4 if needed, using only the remaining filler allowance and a new sterile syringe. Follow-up visits include a virtual safety check at Week 2 and in-person evaluations at Week 4, Month 3, and Month 6. During the study, standardized photographs will be taken at baseline, Week 4, Month 3, and Month 6 to assess changes in fold severity, with independent reviewers unaware of the visit order. Participants will complete questionnaires about their satisfaction and experience. The primary outcome is the change in nasolabial fold severity, and secondary outcomes include overall aesthetic improvement. The study lasts six months, with no cost to participants and voluntary involvement.

Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1