A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds
Phase: NA
Conditions: Nasolabial Fold Correction, Facial Aging, Skin Rejuvenation, Wrinkles Such as Nasolabial Folds
Sponsor: Dr. Joseph M Novoa Libermann

 
Study Title: A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal 
Filler for the Treatment of Nasolabial Folds 
IRAS Short Title: Bridging Technique Validation for Nasolabial Folds – JN-BRIDGE1 
IRAS Project ID: 360828 
REC Reference: 25/NW/0251 
NHS REC Form Reference: 25/PR/1094 
Sponsor Reference: JNL-BridgingNL-2025 
Protocol Number: JN-BRIDGE-2025-01 
Sponsor: JNL Aesthetics Limited, 10 Marsh Street, Warrington, WA1 3QA, UK 
Chief Investigator: Prof. Joseph Mitchell Novoa Libermann (GMC #7200191 | MBBS | QCCP-qualified in 
Dermal Fillers & Neurotoxins) 
NCT Number: (to be assigned upon PRS registration) 
Document Title: Study Protocol 
Version / Date: Version 1.0, 01 August 2025 – REC approved 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Research Protocol 
IRAS Project ID: 360828 
Internal study reference code: JNL-BridgingNL-2025 
Title: A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for 
the Treatment of Nasolabial Folds 
Chief Investigator: Prof. Joseph Mitchell Novoa Libermann 
Sponsor: JNL Aesthetics Limited 
Site: Ascencia Aesthetics Academy, 10 Marsh Street, Warrington, UK 
Version: 1.0 
Date: 01 August 2025 
 
1. Background and Rationale 
Nasolabial folds (NLFs), the lines extending from the sides of the nose to the corners of the mouth, are 
among the most common age-related concerns in aesthetic medicine. Loss of volume in deep facial fat 
compartments and changes in skin elasticity contribute to their formation. While several filler techniques 
are available and widely used, clinical practice lacks standardisation on a technique that balances safety, 
minimal invasiveness, and natural outcomes. 
The Bridging Technique is a novel filler method that uses a blunt-tipped cannula to place horizontal 
threads of HA filler across the fold within the deep dermis and subdermal (superficial fat) layer. This 
strategy supports the skin internally, aiming for a natural correction with low product volume and 
reduced risk of vascular compromise. 
The term “Bridging” refers to the creation of bridge-like internal support structures beneath the 
nasolabial fold using small, precisely placed filler threads. These threads act as scaffolding, helping to lift 
and soften the fold without overfilling or distorting the natural contours of the face. 
This study will evaluate the clinical and subjective outcomes of this technique using AILEENE Vol. 2, a CE-
marked and MHRA-registered HA filler. 
2. Objectives 
Primary Objective 
To assess changes in nasolabial fold appearance using the validated Nasolabial Fold Severity Scale 
(NLFSS) from baseline to 6 months. 
Secondary Objectives 
• 
To assess patient satisfaction using the Global Aesthetic Improvement Scale (GAIS). 
• 
To measure treatment longevity over a 6-month period. 
• 
To document how many participants request a top-up treatment at 4 weeks. 
• 
To evaluate subjective feedback using a short 5-item PROM (Patient-Reported Outcome 
Measure). 

 
 
 
3. Study Design 
This study is designed as a prospective, interventional, single-arm clinical evaluation. It will be carried 
out at a single private aesthetic clinic in the UK and aims to assess the performance, safety, and patient 
satisfaction associated with a specific dermal filler technique used in routine aesthetic practice. 
A total of 60 adult participants will receive one treatment session with AILEENE Vol. 2 dermal filler using 
the Bridging Technique. Participants will attend a total of four clinic visits over a six-month period, with 
an additional check-in conducted remotely at two weeks post-treatment. An optional top-up may be 
offered at the four-week visit, depending on clinical judgement and patient preference. 
This is an open-label study with no control group. The intention is to evaluate the technique in a real-
world clinical setting, using standardised outcome tools and anonymised photographic assessments. 
Key elements of the study design are as follows: 
• 
Study type: Prospective, single-arm, non-randomised, interventional 
• 
Setting: Ascencia Aesthetics Academy, Warrington (private non-NHS site) 
• 
Sample size: 60 participants 
• 
Product: AILEENE Vol. 2 dermal filler (maximum of 1.0ml per participant) 
• 
Injection method: Bridging Technique using a 25G blunt-tipped cannula 
• 
Injection plane: Deep dermis / subdermal (superficial fat layer) 
• 
Follow-up visits: Day 0 (treatment), Week 2 (virtual check-in), Week 4, Month 3, and Month 6 
• 
Outcome assessments: NLFSS scoring, GAIS, a 5-item patient-reported outcome questionnaire 
(PROM), and documentation of any adverse events 
This design was chosen to provide observational performance data for a CE-marked, MHRA-registered 
product used in a novel but routine aesthetic application. The absence of a control arm reflects the 
exploratory nature of the study and the focus on documenting standard clinical outcomes in a well-
defined patient group. 
 
 
 
 
 
 

 
4. Eligibility Criteria 
Inclusion Criteria 
• 
Adults aged 30 to 65 years 
• 
Bilateral nasolabial folds graded ≥2 on the NLFSS 
• 
General good health 
• 
Willingness to abstain from additional facial aesthetic procedures for the study duration 
• 
Capacity to provide written informed consent 
• 
Individuals of childbearing potential will be required to undergo a urine pregnancy test on the 
day of treatment. The test will be provided at the clinic. Only those with a negative result will be 
eligible to proceed with treatment on that day. 
Exclusion Criteria 
• 
Known allergy to hyaluronic acid, lidocaine, or any filler components 
• 
Active local skin infection or inflammation 
• 
History of permanent implants or semi-permanent fillers in the treatment area 
• 
Anticoagulant therapy or bleeding disorder 
• 
Pregnancy or breastfeeding: 
o 
 There is currently insufficient research to establish the safety of dermal fillers, including 
AILEENE Vol. 2, during pregnancy or breastfeeding. Although no specific risks to the 
mother or fetus have been conclusively identified, the absence of evidence does not 
confirm the absence of risk. As a precaution, individuals who are pregnant, planning to 
become pregnant, or breastfeeding are not eligible to participate in this study and 
should not undergo this treatment. 
• 
Keloid or hypertrophic scarring history 
• 
Uncontrolled diabetes or severe systemic illness 
• 
Recent cosmetic procedures in the lower face (within 6–12 months depending on treatment 
type) 
 
 
 
 
 
 

 
5. Study Schedule 
Each participant will be involved in the study for a period of six months and will attend four in-person 
visits, along with one virtual check-in. The schedule is as follows: 
• 
Visit 1 (Day 0): Following informed consent and screening, participants will undergo baseline 
assessments, including clinical photographs, and will receive the initial treatment using the 
Bridging Technique. 
• 
Check-in (2 weeks post-treatment): A virtual follow-up will be conducted by phone or video to 
assess short-term safety and patient experience. 
• 
Visit 2 (Week 4): Participants will return for an in-clinic review. Standardised photographs will be 
taken, PROMs collected, and an optional top-up treatment offered if clinically indicated. 
• 
Visit 3 (Month 3): A follow-up appointment will assess progress, capture updated photography, 
and gather further feedback using GAIS and PROMs. 
• 
Visit 4 (Month 6): The final study visit will include repeat clinical photography, final PROM 
completion, and closure of participation. 
 
6. Outcome Measures 
Primary Endpoint 
Change in NLFSS score from baseline to 6 months, assessed by blinded independent reviewers using 
anonymised photographs. 
Statistical Method: Paired T-Test 
Secondary Endpoints 
• 
GAIS scores at each follow-up 
• 
Subjective PROM results on satisfaction, comfort, and naturalness 
• 
Proportion receiving top-up filler at Week 4 
• 
Documentation of adverse events 
 
7. Data Management 
Each participant will be assigned a unique study ID. 
Clinical photographs will be obtained using the Bitmoji A5-AI device, stripped of metadata and securely 
stored. 
All data will be recorded electronically in Clever Clinic, with access restricted to the investigator and 
authorised staff. Data will be managed in accordance with the UK GDPR and Data Protection Act 2018. 
 

 
 
8. Safety and Risk Considerations 
Risks are consistent with routine aesthetic filler procedures and include bruising, swelling, tenderness, 
nodules, asymmetry, or in rare cases, vascular occlusion or allergic reaction. 
Emergency protocols, including the use of hyaluronidase, will be in place. The Chief Investigator has 
extensive training in complication management. No data monitoring committee is required due to the 
low-risk profile and non-NHS setting. 
 
9. Insurance and Indemnity 
The study is sponsored by JNL Aesthetics Limited, which holds indemnity cover. The Chief Investigator 
holds additional professional indemnity insurance. This is not a CTIMP and does not involve the use of an 
investigational device. 
 
10. Dissemination 
Study findings will be submitted for publication in academic journals and presented at national or 
international conferences. A plain-language summary will be made available to participants who opt in 
to receive it. The study will be listed on ClinicalTrials.gov prior to the first enrolment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
End of Document 
Protocol Version: 1.0  Date: 01 August 2025