Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
Healthy Volunteers
NCT07178119

Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

Led by Dr. Joseph M Novoa Libermann · Updated on 2025-12-04

60

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

Sponsors

D

Dr. Joseph M Novoa Libermann

Lead Sponsor

C

Cg Bio Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

Who Can Participate

Age: 30Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 30 to 65 years, inclusive, at the time of screening.
  • Male or female, able and willing to comply with study procedures.
  • Visible bilateral nasolabial folds with a severity score of 2 or higher.
  • Willing to receive facial dermal filler treatment using the Bridging Technique with AILEENE Vol. 2.
  • Generally in good health without uncontrolled chronic illness or active skin disease affecting treatment.
  • Able to provide written informed consent and understand the study.
  • Willing to avoid other facial cosmetic procedures during the 6-month study.
  • Agree to photographic documentation and use of anonymized photos for evaluation and publication.
  • For women of childbearing potential: negative urine pregnancy test at baseline.
Not Eligible

You will not qualify if you...

  • Nasolabial folds scored less than 2 on either side.
  • Allergic or hypersensitive to hyaluronic acid, lidocaine, or any component of AILEENE Vol. 2.
  • History of severe allergic reactions, anaphylaxis, or allergy to local anesthetics.
  • Dermal filler, permanent implant, or cosmetic procedure in the nasolabial fold 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 6 months.
  • Active skin infection, inflammation, herpes simplex, acne, or other skin condition in the treatment area.
  • Use of topical retinoids or corticosteroids on the face within 30 days before treatment.
  • Use of anticoagulant, antiplatelet, or NSAIDs within 14 days before treatment.
  • History of bleeding disorders.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

JNL Aesthetics Limited

Warrington, Cheshire, United Kingdom, WA4 1DQ

Actively Recruiting

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Research Team

P

Prof. Joseph M Novoa Libermann, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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