Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
United Kingdom60 participantsStarted 2025-11-22
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 V…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Nasolabial Fold Severity using the Nasolabial Fold Severity Scale (NLFSS)