THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER

NCT07763990 | Recruiting DMC

• 1 other identifier: HL01IL2022
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months after the injection

Study Arms (3)

Group 1 - Lips

EXPERIMENTAL

HLR-1, maximum of 3ml per upper and lower lip area, (1.5ml max at the touch-up treat

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.

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.

Device: HLR-3

Interventions

HLR-1 DEVICE

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.

Group 1 - Lips

HLR-2 DEVICE

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.

Group 2 - Nasolabial folds (NLF)

HLR-3 DEVICE

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.

Group 3 - Cheeks

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Hallura Ltd.: lead
• Shaare Zedek Medical Center: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (2)

Hallura Ltd

Tel Aviv, 2069202, Israel

COMPLETED

Ichilov Medical Center

Tel Aviv, Israel

RECRUITING

Central Study Contacts

Judith Antler

CONTACT

972527278333; judith@hallura.com

Galit Dodek

CONTACT

972526334352; galit@hallura.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: January 9, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

IL (2)