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A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds (BRIDGING)
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.
Details
| Lead sponsor | Dr. Joseph M Novoa Libermann |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 60 |
| Start date | 2025-11-22 |
| Completion | 2026-11 |
Conditions
- Nasolabial Fold Correction
- Facial Aging
- Skin Rejuvenation
- Wrinkles Such as Nasolabial Folds
Interventions
- (Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2
Primary outcomes
- Change in Nasolabial Fold Severity using the Nasolabial Fold Severity Scale (NLFSS) — 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
Countries
United Kingdom