Status:
RECRUITING
Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
Lead Sponsor:
Dr. Joseph M Novoa Libermann
Collaborating Sponsors:
Cg Bio Co., Ltd.
Conditions:
Nasolabial Fold Correction
Facial Aging
Eligibility:
All Genders
30-65 years
Phase:
NA
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 t...
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 chang...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07178119
Start Date
November 22 2025
End Date
November 1 2026
Last Update
December 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
JNL Aesthetics Limited
Warrington, Cheshire, United Kingdom, WA4 1DQ