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RECRUITING

NCT07178119

Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1

Sponsor: Dr. Joseph M Novoa Libermann

View on ClinicalTrials.gov

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.

Official title: A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-22

Completion Date

2026-11

Last Updated

2025-12-04

Healthy Volunteers

Yes

Conditions

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

Interventions

PROCEDURE

(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using 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.

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.

Locations (1)

JNL Aesthetics Limited

Warrington, Cheshire, United Kingdom