Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

NCT07178119 | Recruiting

• 1 other identifier: JNL-BridgingNL-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkles Such as Nasolabial Folds; Nasolabial Fold Correction; Facial Aging; Skin Rejuvenation

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)

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (Day 0), Week 4, Month 3, and Month 6

Secondary Outcomes (1)

• Change in Aesthetic Appearance using the Global Aesthetic Improvement Scale (GAIS)

  Week 4, Month 3, and Month 6

Other Outcomes (2)

• Patient Satisfaction and Treatment Experience Using a Five-Item Patient-Reported Outcome Measure (PROM)

  Week 4, Month 3, and Month 6

• Proportion of Participants Requesting Top-Up Treatment at Week 4

  Week 4

Study Arms (1)

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.

Procedure: (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2

Interventions

(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2 PROCEDURE

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.

Also known as: Bridging Technique for Nasolabial Folds, Horizontal Cannula Injection for Nasolabial Folds, Cannula Technique for Nasolabial Folds, AILEENE Vol. 2, Hyaluronic Acid Dermal Filler, HA Filler

Bridging Technique with AILEENE Vol. 2

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Joseph M Novoa Libermann: lead
• Cg Bio Co., Ltd.: collaborator

Study Sites (1)

JNL Aesthetics Limited

Warrington, Cheshire, WA4 1DQ, United Kingdom

RECRUITING

Related Links

• PDF brochure detailing physical and structural properties of AILEENE Vol. 2, including its multi-layered phasic structure and rheological metrics.
• 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.

Study Officials

• Joseph M Novoa Libermann, MBBS

  JNL Aesthetics Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Joseph M Novoa Libermann, MBBS

CONTACT

+44 7722260964; drjoe@jnlaesthetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a prospective, single-arm study and is therefore registered as Open Label. Participant, care provider, and investigator masking is not possible. However, outcome assessment is blinded. Standardized photographs obtained at Baseline (Day 0), Week 4, Month 3, and Month 6 will be evaluated by two independent observers who are not involved in treatment or follow-up. Observers are blinded to participant identity and to the chronological order of images; discrepancies are resolved by consensus. A virtual safety check is performed at Week 2; no formal outcome scoring occurs at this time.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 17, 2025
• Study Start: November 22, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)