Nasolabial Fold CorrectionBRIDGINGNCT07178119
Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
A study testing (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2 in people with Nasolabial Fold Correction and Facial Aging, run by Dr. Joseph M Novoa Libermann at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold Correction, Facial Aging, Skin Rejuvenation
- What is being tested?
- (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
JNL Aesthetics Limited
Warrington, Cheshire, WA4 1DQ
Prof. Joseph M Novoa Libermann, MBBS, 07722260964, admin@jnlaesthetics.com
About this study
Official title: A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds
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?
Read more
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.
Read the detailed description
Nasolabial folds (NLF) are a visible sign of facial aging and one of the most frequent concerns expressed by patients seeking non-surgical facial rejuvenation. These folds develop due to natural changes in skin elasticity, soft tissue support, and fat distribution. Many patients now request outcomes that are natural in appearance, rather than overly augmented, and wish to achieve this with the least amount of product and downtime.
The Bridging Technique was developed by Dr. Joseph Novoa Libermann in response to this clinical demand. The technique involves the placement of small threads of HA filler across the nasolabial folds using a cannula introduced through a single entry point. This approach is intended to minimize trauma, reduce the risk of vascular compromise (VC), and provide visible improvement with reduced filler volume compared to more traditional methods.
Although the method has been applied in aesthetic practice for over three years with positive results, it has not yet been validated in a structured clinical study. This trial is therefore designed to generate systematic evidence on safety and effectiveness. The focus is on confirming whether the Bridging Technique can consistently achieve natural-looking improvement in nasolabial fold severity while maintaining a favorable safety profile.
The study will also explore the broader impact on patient satisfaction and perceived improvement by combining independent photographic assessment with patient-reported outcome measures (PROMs). By formally documenting outcomes under ethical review and structured follow-up, the study aims to provide clinicians with robust evidence supporting a safer and more conservative approach to nasolabial fold treatment.
The results are intended to support wider adoption of the technique in aesthetic practice, with potential benefits for patient safety, cost-effectiveness, and treatment satisfaction.
- Conditions
- Nasolabial Fold Correction, Facial Aging, Skin Rejuvenation, Wrinkles Such as Nasolabial Folds
- Being tested
- (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2
- Keywords
- Hyaluronic Acid Filler, Dermal Filler, AILEENE Vol. 2, Bridging Technique, Minimally Invasive Aesthetics, Non-Surgical Facial Rejuvenation, Wrinkle Correction, Global Aesthetic Improvement Scale (GAIS), Nasolabial Fold Severity Scale (NLFSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2Procedure or surgery
Also called Bridging Technique for Nasolabial Folds, Horizontal Cannula Injection for Nasolabial Folds, Cannula Technique for Nasolabial Folds, 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.
| Study group | Role | What they receive |
|---|---|---|
| Bridging Technique with AILEENE Vol. 2 | Experimental | Although AILEENE Vol. 2 is a hyaluronic acid (HA) dermal filler that is Conformité Européenne (CE)-marked and registered with the Medicines and Healthcare products Regulatory Agency (MHRA) for use in routine aesthetic practice, the Bridging Technique for the correction of nasolabial folds (NLF) has not yet been formally evaluated in a structured clinical study. For this reason, the intervention is designated as Experimental in this trial. Receives: Procedure: (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasolabial Fold Severity using the Nasolabial Fold Severity Scale (NLFSS)
The Nasolabial Fold Severity Scale (NLFSS) is a 5-grade photographic severity scale used to rate the depth and appearance of nasolabial folds. It is based on a modified version of the Wrinkle Severity Rating Scale (WSRS), adapted specifically for nasolabial fold evaluation.
Scale:
Grade 0 - Absent: No visible fold Grade 1 - Mild: Shallow fold, barely visible indentation Grade 2 - Moderate: Clear fold, moderate indentation Grade 3 - Severe: Deep and prominent fold Grade 4 - Very Severe: Very deep, highly visible fold with sharp demarcation
Two independent blinded observers will compare baseline and follow-up photographs of each participant against the NLFSS reference images and assign scores. Any discrepancies will be resolved by consensus. Improvement is defined as a decrease in score from baseline.Statistical analysis will use a paired t-test
Measured: Baseline (Day 0), Week 4, Month 3, and Month 6
Secondary outcomes (1)
Change in Aesthetic Appearance using the Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale (GAIS) is a five-point scale that measures overall aesthetic improvement compared with baseline:
- = Very much improved
- = Much improved
- = Improved
- = No change
- = Worse
Two independent blinded observers will assess standardized photographs using the GAIS. Participants will also complete a self-assessment GAIS questionnaire at each follow-up visit.
Measured: Week 4, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start22 Nov 2025
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm clinical evaluation study of the Bridging Technique using AILEENE Vol. 2 hyaluronic acid (HA) dermal filler for the correction of nasolabial folds (NLF). All enrolled participants will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Joseph M Novoa Libermann
- Sponsor type
- University, hospital or other
- Collaborators
- Cg Bio Co., Ltd.
- Responsible party
- Sponsor-investigator, Dr. Joseph M Novoa Libermann, JNL Aesthetics Limited
- Investigators
- Joseph M Novoa Libermann, MBBS, Principal investigator, JNL Aesthetics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178119
- Sponsor's protocol ID
- JNL-BridgingNL-2025
- Other IDs
- JNL-BridgingNL-2025
- Acronym
- BRIDGING
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This is a single-site aesthetic medicine study with a small sample size (n=60). To protect participant confidentiality, only anonymised summary results will be made publicly available on ClinicalTrials.gov. Study findings will also be submitted for publication in a peer-reviewed scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07178119
- Acronym / sponsor ID
- BRIDGING / JNL-BridgingNL-2025
- Conditions
- Nasolabial Fold Correction, Facial Aging, Skin Rejuvenation, Wrinkles Such as Nasolabial Folds
- Keywords
- Hyaluronic Acid Filler, Dermal Filler, AILEENE Vol. 2, Bridging Technique, Minimally Invasive Aesthetics, Non-Surgical Facial Rejuvenation, Wrinkle Correction, Global Aesthetic Improvement Scale (GAIS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Joseph M Novoa LibermannUniversity, hospital or other
- Collaborators
- Cg Bio Co., Ltd.
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nasolabial folds (NLF) are a visible sign of facial aging and one of the most frequent concerns expressed by patients seeking non-surgical facial rejuvenation. These folds develop due to natural changes in skin elasticity, soft tissue support, and fat distribution. Many patients now request outcomes that are natural in appearance, rather than overly augmented, and wish to achieve this with the least amount of product and downtime.
The Bridging Technique was developed by Dr. Joseph Novoa Libermann in response to this clinical demand. The technique involves the placement of small threads of HA filler across the nasolabial folds using a cannula introduced through a single entry point. This approach is intended to minimize trauma, reduce the risk of vascular compromise (VC), and provide visible improvement with reduced filler volume compared to more traditional methods.
Although the method has been applied in aesthetic practice for over three years with positive results, it has not yet been validated in a structured clinical study. This trial is therefore designed to generate systematic evidence on safety and effectiveness. The focus is on confirming whether the Bridging Technique can consistently achieve natural-looking improvement in nasolabial fold severity while maintaining a favorable safety profile.
The study will also explore the broader impact on patient satisfaction and perceived improvement by combining independent photographic assessment with patient-reported outcome measures (PROMs). By formally documenting outcomes under ethical review and structured follow-up, the study aims to provide clinicians with robust evidence supporting a safer and more conservative approach to nasolabial fold treatment.
The results are intended to support wider adoption of the technique in aesthetic practice, with potential benefits for patient safety, cost-effectiveness, and treatment satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm clinical evaluation study of the Bridging Technique using AILEENE Vol. 2 hyaluronic acid (HA) dermal filler for the correction of nasolabial folds (NLF). All enrolled participants will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Bridging Technique with AILEENE Vol. 2 | Experimental | Procedure: (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2Although AILEENE Vol. 2 is a hyaluronic acid (HA) dermal filler that is Conformité Européenne (CE)-marked and registered with the Medicines and Healthcare products Regulatory Agency (MHRA) for use in routine aesthetic practice, the Bridging Technique for the correction of nasolabial folds (NLF) has not yet been formally evaluated in a structured clinical study. For this reason, the intervention is designated as Experimental in this trial. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2Also: Bridging Technique for Nasolabial Folds, Horizontal Cannula Injection for Nasolabial Folds, Cannula Technique for Nasolabial Folds, AILEENE Vol. 2Participants 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. | Procedure or surgery | Bridging Technique with AILEENE Vol. 2 |
Primary outcome
Change in Nasolabial Fold Severity using the Nasolabial Fold Severity Scale (NLFSS)
Time frame: Baseline (Day 0), Week 4, Month 3, and Month 6
The Nasolabial Fold Severity Scale (NLFSS) is a 5-grade photographic severity scale used to rate the depth and appearance of nasolabial folds. It is based on a modified version of the Wrinkle Severity Rating Scale (WSRS), adapted specifically for nasolabial fold evaluation. Scale: Grade 0 - Absent: No visible fold Grade 1 - Mild: Shallow fold, barely visible indentation Grade 2 - Moderate: Clear fold, moderate indentation Grade 3 - Severe: Deep and prominent fold Grade 4 - Very Severe: Very deep, highly visible fold with sharp demarcation Two independent blinded observers will compare baseline and follow-up photographs of each participant against the NLFSS reference images and assign scores. Any discrepancies will be resolved by consensus. Improvement is defined as a decrease in score from baseline.Statistical analysis will use a paired t-test
1 secondary outcome
Change in Aesthetic Appearance using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Week 4, Month 3, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- PDF brochure detailing physical and structural properties of AILEENE Vol. 2, including its multi-layered phasic structure and rheological metrics.Link provided by the sponsor.
- CG Bio research page. CG Bio is the manufacturer of AILEENE Vol. 2 dermal filler and publishes educational scientific materials, although it is not the study sponsor.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This is a single-site aesthetic medicine study with a small sample size (n=60). To protect participant confidentiality, only anonymised summary results will be made publicly available on ClinicalTrials.gov. Study findings will also be submitted for publication in a peer-reviewed scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph M Novoa Libermann, MBBS principal investigator
JNL Aesthetics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2 in people with Nasolabial Fold Correction and Facial Aging, run by Dr. Joseph M Novoa Libermann at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Joseph M Novoa Libermann, MBBS (+44 7722260964, drjoe@jnlaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nasolabial Fold Severity using the Nasolabial Fold Severity Scale (NLFSS) (time frame: Baseline (Day 0), Week 4, Month 3, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.