BridgeMD
New treatment option for Nasolabial Fold Correction
Official title Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1
ClinicalTrials.gov ID: NCT07178119
What this study is testing
- What it's testing
- 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?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65. Healthy volunteers may be eligible.
You may be able to join 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warrington, Cheshire, United Kingdom
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warrington, Cheshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.