Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

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.

Inclusion criteria

Adults aged 30 to 65 years, inclusive, at the time of screening.

Male or female, able and willing to comply with study procedures.

Presence of visible bilateral nasolabial folds (NLF), each with a score of 2 or higher on the Nasolabial Fold Severity Scale (NLFSS), as assessed by the Principal Investigator.

Willing to undergo facial dermal filler treatment using the Bridging Technique with AILEENE Vol. 2.

In generally good health, without uncontrolled chronic illness or active skin disease that could interfere with treatment or healing.

Able to provide written informed consent and understand the nature and purpose of the study.

Willing to refrain from undergoing any other facial cosmetic procedures (e.g., dermal fillers, botulinum toxin, laser, surgery, or radiofrequency) during the six-month study period.

Agree to photographic documentation of the treatment area and follow-up assessments, and willing to allow use of anonymized photographs for blinded evaluation and publication.

For women of childbearing potential: negative urine pregnancy test at baseline.

Female participants of childbearing potential will undergo a urine pregnancy test on the day of treatment as a safety precaution, since there is insufficient evidence on filler safety during pregnancy.

Exclusion criteria

Presence of NLF graded less than 2 on the NLFSS on either side of the face.

Known allergy or hypersensitivity to hyaluronic acid (HA), lidocaine, or any component of AILEENE Vol. 2.

History of severe allergic reactions, anaphylaxis, or allergy to local anesthetics.

Prior use of dermal fillers, permanent implants, or other cosmetic procedures in the NLF area or lower face within the past 12 months.

Use of botulinum toxin, chemical peels, laser, radiofrequency, or cryotherapy in the mid- or lower face within the last six months.

Active skin infection, inflammation, herpes simplex (cold sore), acne, or other dermatologic condition in the treatment area.

Use of topical medications such as retinoids or corticosteroids on the face within 30 days prior to treatment.

Current or recent use (within 14 days) of anticoagulant, antiplatelet, or non-steroidal anti-inflammatory drugs (NSAIDs) that may increase the risk of bruising or bleeding.

History of bleeding disorders.