Actively Recruiting
A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds
Led by Dr. Joseph M Novoa Libermann · Updated on 2025-12-04
60
Participants Needed
1
Research Sites
26 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
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.
CONDITIONS
Brief Title
Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
Who Can Participate
Eligibility Criteria
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 on the Nasolabial Fold Severity Scale
- Willing to undergo facial dermal filler treatment using the Bridging Technique with AILEENE Vol. 2
- Generally good health without uncontrolled chronic illness or active skin disease affecting treatment or healing
- Able to provide written informed consent and understand the study purpose
- Willing to avoid other facial cosmetic procedures during the six-month study period
- Agree to photographic documentation and use of anonymized photos for evaluation and publication
- For women of childbearing potential: negative urine pregnancy test at baseline
You will not qualify if you...
- Nasolabial folds graded less than 2 on the Nasolabial Fold Severity Scale on either side
- Allergy or hypersensitivity to hyaluronic acid, lidocaine, or components of AILEENE Vol. 2
- History of severe allergic reactions or allergy to local anesthetics
- Prior dermal fillers, permanent implants, or cosmetic procedures in the nasolabial fold or lower face within 12 months
- Use of botulinum toxin, chemical peels, laser, radiofrequency, or cryotherapy in the mid- or lower face within 6 months
- Active skin infection, inflammation, herpes simplex, acne, or other skin conditions in the treatment area
- Use of topical retinoids or corticosteroids on the face within 30 days before treatment
- Current or recent use (within 14 days) of anticoagulant, antiplatelet, or NSAID medications
- History of bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with follow-up for 6 months
Participants receive one treatment using the Bridging Technique with AILEENE Vol. 2 dermal filler for nasolabial folds. An optional single top-up may be provided at Week 2 or Week 4 if needed.
1 baseline treatment visit and up to 1 optional top-up visit at Week 2 or Week 4
Duration - 6 months
Participants are followed for safety and effectiveness with standardized photographs and assessments over 6 months after treatment.
Visits at Week 4, Month 3, and Month 6 for assessments and photographs
Trial Site Locations
Total: 1 location
1
JNL Aesthetics Limited
Warrington, Cheshire, United Kingdom, WA4 1DQ
Actively Recruiting
Research Team
P
Prof. Joseph M Novoa Libermann, MBBS
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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