Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Cg Bio Co., Ltd.

  collaborator INDUSTRY

• Dr. Joseph M Novoa Libermann

  lead OTHER

Principal Investigators

• Joseph M Novoa Libermann, MBBS · JNL Aesthetics Limited

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-11-22

Primary Completion

2026-05-31

Completion

2026-11-30

Countries

• United Kingdom

Study Locations