A Randomized, Blinded Evaluator, No-treatment Control, Multicenter, Prospective Clinical Study of RHA® Redensity Eye for the Treatment of Moderate to Severe Tissue Volume Deficiencies in the Infraorbital Regions

Detailed Summary

This is a multicenter, blinded evaluator, randomized, prospective, no treatment control clinical study to identify whether RHA® Redensity Eye (\*) is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital regions. The study will include at least 20% of subjects with Fitzpatrick skin types IV-VI. The Treating Investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate the subject's infraorbital hollows independently of each other using the Teoxane Infraorbital Hollows Scale (TIOHS) at Screening (Visit 1) for eligibility. If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint. Enrolled subjects will be randomly assigned in a ratio of 3:1 at Screening (Visit 1) to receive RHA® Redensity Eye or to receive no treatment (No-treatment control group). Subjects receiving RHA® Redensity Eye will be further divided by the method of administration (i.e. injection with a 30G ½" needle or 25G 1 ½" cannula), which will be defined for each site at the beginning of the study. Site selection will aim to achieve approximately 1:1 distribution between the administration method subgroups. The BLE will be blinded to the study groups (RHA® Redensity Eye group or No treatment control group). For subjects randomly assigned to RHA® Redensity Eye group, the study will be conducted in 2 Phases - Phase 1a and Phase 2. For subjects randomly assigned to No-treatment control group, the study will be conducted in 3 Phases - Phase 1a, Phase 1b and Phase 2. The Phase 1b is not applicable for the subject assigned to the RHA® Redensity Eye group. (\*): TEO-RHA-1902 was conducted with RHA® Redensity Eye Lido, that contains Lidocaine.

Study Details

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Interventions