Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorDr. Joseph M Novoa Libermann
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2
Procedure/SurgeryParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Bridging Technique with AILEENE Vol. 2Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline (Day 0), Week 4, Month 3, and Month 6Secondary 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: 1. = Very much improved 2. = Much improved 3. = Improved 4. = No change 5. = 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.
Time frame
Week 4, Month 3, and Month 6Other outcomes
1
Patient Satisfaction and Treatment Experience Using a Five-Item Patient-Reported Outcome Measure (PROM)
A five-item questionnaire will be administered using a five-point Likert scale to assess: 1. -Satisfaction with appearance 2. -Comfort during treatment 3. -Perceived improvement 4. -Willingness to repeat the procedure 5. -Overall satisfaction
Time frame
Week 4, Month 3, and Month 62
Proportion of Participants Requesting Top-Up Treatment at Week 4
The proportion of participants who request or receive an optional top-up filler at the Week 4 visit will be documented in the Case Report Forms(CRFs).
Time frame
Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Joseph M Novoa Libermann
Lead sponsor
JNL Aesthetics Limited
Sponsor institution
Cg Bio Co., Ltd.
Collaborator
Source ClinicalTrials.gov