Lips Enhancement Nasolabial Fold Correction Midface Volume DeficitNCT07763990
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
A study testing HLR-1, HLR-2 and HLR-3 in people with Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit, run by Hallura Ltd. at 2 sites in Israel.
Trial summary
Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
- What is being tested?
- HLR-1, HLR-2 and HLR-3
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesIsrael
- Study dates
- 9 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subject;
- Male or female, over the age of 18;
- Female patients of childbearing potential must declare in the ICF to be non-pregnant at visit 1a prior to initial injection and should use a contraceptive regimen recognized as effective since at least 12 weeks before the beginning of the study, and during the entire duration of the study.
- Subject seeking an aesthetic procedure on the face who can be classified into one of the following groups:
- Group1: Lip volume deficit with ROSSI score between 1.5 and 3 on at least the upper lip, or on both the upper and the lower lips with up to 1-point difference in ROSSI score between upper and lower lips;
- Group 2: Moderate to severe nasolabial folds (NLFs) with WSRS scale score 3 or 4 for each side of the face;
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- Group 3: Mild to significant volume deficit at the cheeks level with MFVDS score 3 to 4 at each side, with up to 1-point difference in MFVDS scale score between the two sides.
- Blinded Live-Evaluator (BLE) and Injector (ILE) must independently agree that the criteria is met on the area to be treated, however concordance of the scores is not required.
- Subject willing to abstain from any aesthetic treatment on the treated area other than the treatments planned in the protocol during the study period.
- Subject informed and having signed and dated the EC approved informed consent form (ICF).
- Subjects agree that his/her imaging will be published without partial covering of the photo, meaning without Anonymization for R\&D, business development, Marketing of Hallura and Publications and for evaluating the 3D imaging by cherry imaging for internal R\&D use.
Who cannot join
- In terms of population
- Subject with abnormal vision assessment at Baseline: either Snellen acuity test worse than 20/40 (with corrections, if applicable) or abnormal confrontational visual field test or abnormal ocular motility test.
- Subject who is pregnant or nursing or planning to become pregnant during the study.
- Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship, such as social or sanitary establishment.
- Subject suspected to be non-compliant according to the investigator's judgment.
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- Participation in another clinical trial concurrent with this study.
- In terms of associated pathology and concomitant treatment
- Subject with a condition or receiving a medication which, in the investigator's judgment, puts the subject under risk.
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- Subject with mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease, and/or severe malocclusion or dentofacial or maxillofacial deformities.
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma, rosacea, blotches or other pathology on the studied zones, at the investigator appreciation). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion.
- Subject who has a known history of multiple allergies, allergic/anaphylactic reactions including allergy to lidocaine or anaesthetics of the amide type, to hyaluronic acid products, or to Gram-positive bacterial proteins.
- Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
- Subject with a history of precancerous lesions/skin malignancies.
- Subject predisposed to keloids or hypertrophic scarring.
- Subject with known history of hyper- or hypo-pigmentation in face.
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject having received high dose of Lidocaine (more than 200mg) and/or high dose of anaesthetics structurally related to amide-type during the week before the injection session.
- Have received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, garlic, gingko), fish oil or vitamin C from 10 days pre- to 3 days post injection [Study device injections may be delayed as necessary to accommodate this 10-day washout period.]
- For group 1, abnormal rating in lip movement / lip function / lip sensation.
- Subject undergoing one of the following systemic or topical (on the test area) treatments:
- anti-histamines during the 2 weeks prior to study start;
- immunosuppressors and/or corticoids during the 4 weeks prior to study start;
- retinoids during the 6 months prior to study start.
- Subjects suffering from untreated epilepsy;
- In terms of lifestyle
- Subject having received injection with a temporary bioresorbable facial dermal filler (e.g., hyaluronic acid, collagen, autologous fat, etc.) within the past 12 months prior to study start.
- Botulinum toxin injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study.
- Subjects having received at any time permanent facial implants (e.g. polyacrylamide, PMMA, silicone) anywhere in the face or neck.
- Had undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid, etc.) in the face within 24 months before enrolment.
- Subject having received at any time a treatment with tensor threads or gold strands on the face.
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 1 recruiting
- Completed
Hallura Ltd
Tel Aviv, 2069202
- Recruiting
Ichilov Medical Center
Tel Aviv
Prof. Ofir Artzi, Prof, 03-6972424, ofira@tlvmc.gov.il
About this study
Official title: PROSPECTIVE, INTERVENTIONAL, NON-RANDOMIZED, OPEN LABEL, BLINDED STUDY FOR THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.
- Being tested
- HLR-1, HLR-2, HLR-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLR-1Device
Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome.
The Maximum allowable dose for the touch up treatments is half of initial dose for the whole lips.
HLR-2Device
Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome.
The Maximum allowable dose for the touch up treatments is half of initial dose by side.
HLR-3Device
Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome.
The Maximum allowable dose for the touch up treatments is half of initial dose by side.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Lips | Experimental | HLR-1, maximum of 3ml per upper and lower lip area, (1.5ml max at the touch-up treat Receives: Device: HLR-1 |
| Group 2 - Nasolabial folds (NLF) | Experimental | HLR-2, maximum of 3ml per NLF, (1.5ml max at the touch-up treatment, if performed) injected in the mid to deep dermis. Receives: Device: HLR-2 |
| Group 3 - Cheeks | Experimental | HLR-3, maximum of 4ml per side, (2 ml max at the touch-up treatment, if performed) injected in the deep dermis or subcutaneous to supraperiosteal layers of the cheeks. Receives: Device: HLR-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate
Clinical scoring:
The assessment of lip volume, wrinkles severity of nasolabial folds and cheeks volume will be performed by the ILE and validated with BLE (blinded live evaluator) assessment using the respectively structured scale ROSSI, WSRS or MFVDS. At each scoring event, one score for the upper lip will be given for subjects in group 1, two scores for right and left NLF for subjects in group 2 and two scores for right and left cheeks for subjects in group 3.
For each group, in order to demonstrate a product efficacy, the responder rate proportion in clinical scoring should be significantly higher than 60% using a one-tailed binomial test at the Alpha=0.05 significance level.
Measured: 3 months for Group 1, 6 months for Groups 2 and 3
Safety Evaluation
Prior to statistical analyses, all the AEs will be coded using the Medical Dictionary MedDRA®.
Will be presented by System Organ Class and Preferred Term:
- All Adverse Events
- All Serious Adverse Events
- All Adverse Device Effects
The number and percentage of patients experiencing at least one AE / SAE / ADE occurring over 6 months and 12 months after the injection will be provided as well.
AEs will also be tabulated by:
- Seriousness criterion
- Severity
- Relationship with the product
- Relationship with CIP procedure
- Outcome
The individual listing of AE will be provided. The main analysis will be performed globally on the entire safety population over the 3 groups. Analysis per group will also be realized, as well as broken down by sub-group of subjects with and without touch-up.
Measured: 12 months after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start9 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lips Enhancement Nasolabial Fold Correction Midface Volume DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallura Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center, Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763990
- Sponsor's protocol ID
- HL01IL2022
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE, INTERVENTIONAL, NON-RANDOMIZED, OPEN LABEL, BLINDED STUDY FOR THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
- ClinicalTrials.gov ID
- NCT07763990
- Acronym / sponsor ID
- HL01IL2022
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hallura Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center, Tel-Aviv Sourasky Medical Center
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the safety and performance of the investigational device in its three concentrations for cheek and lips augmentation and correction of the nasolabial folds, assuming that the performance of the product will be demonstrated based on the responder rates observed compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Lips | Experimental | Device: HLR-1HLR-1, maximum of 3ml per upper and lower lip area, (1.5ml max at the touch-up treat |
| Group 2 - Nasolabial folds (NLF) | Experimental | Device: HLR-2HLR-2, maximum of 3ml per NLF, (1.5ml max at the touch-up treatment, if performed) injected in the mid to deep dermis. |
| Group 3 - Cheeks | Experimental | Device: HLR-3HLR-3, maximum of 4ml per side, (2 ml max at the touch-up treatment, if performed) injected in the deep dermis or subcutaneous to supraperiosteal layers of the cheeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy Subject;
- Male or female, over the age of 18;
- Female patients of childbearing potential must declare in the ICF to be non-pregnant at visit 1a prior to initial injection and should use a contraceptive regimen recognized as effective since at least 12 weeks before the beginning of the study, and during the entire duration of the study.
- Subject seeking an aesthetic procedure on the face who can be classified into one of the following groups:
- Blinded Live-Evaluator (BLE) and Injector (ILE) must independently agree that the criteria is met on the area to be treated, however concordance of the scores is not required.
Key exclusion criteria (35 listed)
- In terms of population
- Subject with abnormal vision assessment at Baseline: either Snellen acuity test worse than 20/40 (with corrections, if applicable) or abnormal confrontational visual field test or abnormal ocular motility test.
- Subject who is pregnant or nursing or planning to become pregnant during the study.
- Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship, such as social or sanitary establishment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLR-1Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose for the whole lips. | Device | Group 1 - Lips |
| HLR-2Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose by side. | Device | Group 2 - Nasolabial folds (NLF) |
| HLR-3Initial injection of HLR-1 and a touch-up treatment can occur 30 ± 7 days after the initial treatment if the Injector and Subject determine that additional HLR Dermal Filler would improve the aesthetic outcome. The Maximum allowable dose for the touch up treatments is half of initial dose by side. | Device | Group 3 - Cheeks |
Primary outcome
Responder Rate
Time frame: 3 months for Group 1, 6 months for Groups 2 and 3
Clinical scoring: The assessment of lip volume, wrinkles severity of nasolabial folds and cheeks volume will be performed by the ILE and validated with BLE (blinded live evaluator) assessment using the respectively structured scale ROSSI, WSRS or MFVDS. At each scoring event, one score for the upper lip will be given for subjects in group 1, two scores for right and left NLF for subjects in group 2 and two scores for right and left cheeks for subjects in group 3. For each group, in order to demonstrate a product efficacy, the responder rate proportion in clinical scoring should be significantly higher than 60% using a one-tailed binomial test at the Alpha=0.05 significance level.
Safety Evaluation
Time frame: 12 months after the injection
Prior to statistical analyses, all the AEs will be coded using the Medical Dictionary MedDRA®. Will be presented by System Organ Class and Preferred Term: * All Adverse Events * All Serious Adverse Events * All Adverse Device Effects The number and percentage of patients experiencing at least one AE / SAE / ADE occurring over 6 months and 12 months after the injection will be provided as well. AEs will also be tabulated by: * Seriousness criterion * Severity * Relationship with the product * Relationship with CIP procedure * Outcome The individual listing of AE will be provided. The main analysis will be performed globally on the entire safety population over the 3 groups. Analysis per group will also be realized, as well as broken down by sub-group of subjects with and without touch-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLR-1, HLR-2 and HLR-3 in people with Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit, run by Hallura Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Antler (972527278333, judith@hallura.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: 3 months for Group 1, 6 months for Groups 2 and 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.