Bridging Technique with AILEENE Vol. 2 for Softening Nasolabial Folds
A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds
This study will try the Bridging Technique using very small amounts of AILEENE Vol. 2 filler to soften visible nasolabial folds in adults aged 30 to 65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | JNL Aesthetics Limited Academic / other |
| Locations | 1 site (Warrington, Cheshire) |
| Trial ID | NCT07178119 on ClinicalTrials.gov |
What this trial studies
The trial uses a blunt cannula to place thin horizontal threads of hyaluronic acid filler (AILEENE Vol. 2) beneath each nasolabial fold, with each retrograde placement delivering less than 0.05 mL. Treatments are performed bilaterally from a single entry point and aim to provide internal support that lifts and softens the fold while minimizing volume and tissue distortion. Participants receive the Bridging Technique injection and attend structured follow-up visits, including an early virtual safety check and in-person assessments over a six-month period with blinded photographic evaluation and patient-reported outcomes. The protocol is designed to gather systematic safety and effectiveness data to validate the technique beyond anecdotal clinical use.
Who should consider this trial
Good fit: Adults aged 30–65 with visible bilateral nasolabial folds scored ≥2 on the Nasolabial Fold Severity Scale, generally healthy, willing to undergo the Bridging Technique with AILEENE Vol. 2 and to refrain from other facial cosmetic procedures for six months are ideal candidates.
Not a fit: People with very deep or structural facial volume loss, active facial skin disease, uncontrolled chronic illness, prior extensive facial surgery in the treatment area, or those outside the 30–65 age range may not benefit from this approach.
Why it matters
Potential benefit: If successful, the technique could offer natural-looking reduction of nasolabial folds using smaller filler volumes and potentially lower risk of complications compared with bulk filler placement.
How similar studies have performed: The Bridging Technique has several years of positive real-world clinical use reported by practitioners, but it has not previously been validated in a prospective, structured clinical study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Warrington, Cheshire
- JNL Aesthetics Limited — Warrington, Cheshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Joseph M Novoa Libermann, MBBS — JNL Aesthetics Limited
- Study coordinator: Prof. Joseph M Novoa Libermann, MBBS
- Email: drjoe@jnlaesthetics.com
- Phone: +44 7722260964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.