RHA®4 for Midface Volume Deficiency

Plain-language summary

This is a prospective, randomized, controlled, blinded evaluator, multicenter, between subjects clinical study to identify whether RHA4 is non-inferior to a comparator device for treatment of midface volume deficiency 8 weeks after the last treatment (initial or touch-up). At Screening, the treating investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate independently the subject's midface using the validated 5-grade Teoxane Midface Volume Deficit Scale (TMVDS) for eligibility of the subject for the study. The BLE will establish a pretreatment score for assessment of effectiveness. If the assessments of the TI and the BLE are the same or differ exactly by 1 point of the scale, the difference will be considered acceptable. The TI and the BLE need to agree that the subject meets the eligibility criterion (TMVDS grade 2 to 3). If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint. Eligible subjects will be enrolled and randomly assigned in a 3:1 ratio at Screening to receive RHA4 or comparator product. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment with the same product that they received on Visit 1, 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection. Subjects will be followed for 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 4, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented. The subject will then be followed for an additional 12 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (52 weeks after the last treatment) will be considered the study Exit visit. For subjects with re-treatment, the Exit visit will be 12 weeks after the re-treatment. The TI will conduct safety and effectiveness evaluations at each study visit, which will occur: at 4 weeks after the initial and touch-up treatment, 8, 24, and 52 weeks after the last treatment, and after re treatment or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible. A follow-up telephone call for safety will be performed 3 days after each treatment. Subjects will report their common treatment responses (CTRs) in a subject diary for 30 days after each injection. The diary will also include a list of selected AEs potentially associated with injection of dermal fillers for subjects to report if applicable. All efforts should be made by the TI to schedule the applicable visits to allow completion of the CTR diary. A BLE will conduct assessments of effectiveness during the study, including assessment of the primary endpoint 8 weeks after the last treatment. The BLE will be blinded to allocation to groups (RHA4 group or comparator product group). Furthermore, to ensure that they remain blinded and unbiased when making their assessments throughout the study, the BLE, TI, and subjects will not be allowed to refer to each other's effectiveness assessments. All subjects will be instructed to not discuss their study treatment, AEs, or CTRs with the BLE.

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Trial details