NCT07178119

Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dr. Joseph M Novoa Libermann · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to learn whether the Bridging Technique can safely and effectively treat nasolabial folds (NLF, also known as smile lines) in adults. The main questions are: Does the Bridging Technique, which places very small amounts of filler in thin horizontal threads (less than 0.05 milliliters \[ml\] per retrograde placement), improve the appearance of nasolabial folds? Is the treatment safe, and are participants satisfied with the results? The Bridging Technique is a new method of filler injection where very small amounts of hyaluronic acid (HA) filler are placed in thin horizontal lines under the fold using a blunt cannula. These small "bridges" of filler act like internal support, helping to lift and soften the fold without overfilling or distorting the natural shape of the face. Participants will: Receive an HA dermal filler (AILEENE Vol. 2) injected with the Bridging Technique to both nasolabial folds. Attend follow-up visits at Week 2 (virtual safety check), Week 4, Month 3, and Month 6. Have photographs taken at baseline, Week 4, Month 3, and Month 6, which will be reviewed by independent observers who are blinded to the visit sequence. Complete short questionnaires about their satisfaction and experience. The study includes 60 adults aged 30 to 65 years. Each participant may receive up to 1.0 ml of filler in total across both folds. An optional top-up treatment may be offered at Week 2 or Week 4 if clinically indicated, using only the remaining balance of the total 1.0 ml allowance. Any top-up will be performed with a new, sterile syringe, not with filler physically left over from the first visit. There is no cost to participants, and participation is voluntary.

Detailed description

Nasolabial folds (NLF) are a visible sign of facial aging and one of the most frequent concerns expressed by patients seeking non-surgical facial rejuvenation. These folds develop due to natural changes in skin elasticity, soft tissue support, and fat distribution. Many patients now request outcomes that are natural in appearance, rather than overly augmented, and wish to achieve this with the least amount of product and downtime. The Bridging Technique was developed by Dr. Joseph Novoa Libermann in response to this clinical demand. The technique involves the placement of small threads of HA filler across the nasolabial folds using a cannula introduced through a single entry point. This approach is intended to minimize trauma, reduce the risk of vascular compromise (VC), and provide visible improvement with reduced filler volume compared to more traditional methods. Although the method has been applied in aesthetic practice for over three years with positive results, it has not yet been validated in a structured clinical study. This trial is therefore designed to generate systematic evidence on safety and effectiveness. The focus is on confirming whether the Bridging Technique can consistently achieve natural-looking improvement in nasolabial fold severity while maintaining a favorable safety profile. The study will also explore the broader impact on patient satisfaction and perceived improvement by combining independent photographic assessment with patient-reported outcome measures (PROMs). By formally documenting outcomes under ethical review and structured follow-up, the study aims to provide clinicians with robust evidence supporting a safer and more conservative approach to nasolabial fold treatment. The results are intended to support wider adoption of the technique in aesthetic practice, with potential benefits for patient safety, cost-effectiveness, and treatment satisfaction.

Conditions

• Nasolabial Fold Correction
• Facial Aging
• Skin Rejuvenation
• Wrinkles Such as Nasolabial Folds

Interventions

Type	Name	Description
PROCEDURE	(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2	Participants will receive treatment to both NLF using the Bridging Technique. This involves injecting an HA dermal filler (AILEENE Vol. 2) in thin horizontal threads (less than 0.05 milliliters \[ml\] per retrograde placement) under the fold using a blunt cannula. The maximum total dose per participant is 1.0 ml across both folds. Each participant will receive one treatment at baseline (Day 0). An optional single top-up may be given at Week 2 (virtual or in-clinic) or Week 4 if clinically indicated, using only the remaining balance of the 1.0 ml total. Any top-up will be performed with a new, sterile syringe, not with filler left over from the initial treatment. This is a single-treatment course with follow-up for 6 months. Standardized photographs will be taken at Baseline, Week 4, Month 3, and Month 6 for blinded assessment.

Timeline

• Start date: 2025-11-22
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-09-17
• Last updated: 2025-12-04

Locations

1 site across 1 country: United Kingdom