Prospective, controlled, randomized, monocentric, double-blind, split-face non-inferiority clinical study to evaluate the safety and performance of injectable implant based on hyaluronic acid hydrogel with lidocaine for correction of moderate-to-severe nasolabial folds
This study will be a prospective, randomized, controlled, monocentric, double blind (evaluator/s and subject) within subject (split-face) non-inferiority clinical study. 40 Subjects will be randomized to be treated with RefillHA Solid in the NLF on one side of the face and comparator product in the NLF on the other side of the face. The side of the face for each product will be randomly assigned. The investigator performing the evaluations and the subject will be blinded to the treatment assignment. Injections of the study products will be performed by an unblinded Treating Investigator (TI). At Visit 1 (considered baseline if no touch-up performed) eligible subjects, following signing informed consent, will receive injection of RefillHA Solid into left or right NLF, and injection of the control study device into the contralateral NLF (Initial treatment). for a given subject, the RefillHA Solid and control devices to be injected at the same depth between mid to deep dermis, and with the same technique, to be determined at the TI's discretion. The injected volume will be chosen by the TI and depend on the depth of wrinkle to be corrected. The minimum volume into a single NLF per injection session is 0.5 mL and the maximum volume is 2.5 mL, irrespective of the device. At Visit 2, after 4 weeks from baseline, additional NLF correction with the study devices will be provided, if, per treating investigator's opinion, optimal correction was not achieved (touch-up treatment, considered baseline if performed). Only the NLF requiring touch-up will be treated using the same device as originally injected. All subjects are scheduled to return for follow-up examinations at W4, W12, W24, W36 and W52 (Visits 3 to 7, respectively) after final treatment. Subjects will be offered Early Re-Treatment at W24 or W36 (optional retreatment in case of facial asymmetry or if at least one NLF had returned to baseline level). Furthermore, Re-Treatment will be offered to all subjects attending the study visit in W52. Any Re-Treatment will be performed with the RefillHA Solid implant formulation used at the initial treatment, irrespective of the side of face treated.
Study Type
OBSERVATIONAL
Enrollment
12
Glyance Ltd
Lod, Israel, Israel
Wrinkle Severity Rating Scale (WSRS) Improvement Difference Between Treatment Groups at Week 24
Based on primary outcome - Wrinkle Severity Rating Scale (WSRS) improvement difference between treatment groups at week 24. The improvement in WSRS will be analyzed by a non-inferiority statistical model with a 0.5 margin for the difference between treatment groups. WSRS (Wrinkle Severity Rating Scale) is a validated 5-grade instrument for quantitative assessment of the severity of nasolabial folds. The aesthetic results of the treatment will be evaluated by the blind evaluator, separately for NLF on each side (right/left), using the 5-grade photonumeric WSRS. The grades are (grade 1) absent, (grade 2) mild, (grade 3) moderate, (grade 4) severe and (grade 5) extreme. The WSRS score ranges from 1 to 5, with higher scores indicating greater severity of nasolabial folds.
Time frame: [Time Frame: Up to 56 weeks after treatment]
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