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
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
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.
Phase 1a:
Subjects who will be randomly assigned to the RHA® Redensity Eye group at Screening will receive their injection at Visit 1. Subjects will come to the site 12 weeks (primary endpoint) after the initial treatment. Afterwards, subjects will proceed directly to Phase 2.
Subjects randomly assigned to the No-treatment control group at Screening will receive no treatment in Phase 1a of the study. They will come to the site 12 weeks (primary endpoint) after randomization. After completing all assessments, subjects will immediately begin Phase 1b (Visit 1b is on the same day as Visit at Week 12) and will receive their initial treatment with RHA® Redensity Eye.
Phase 1b:
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Once all evaluations applicable for Visit at Week 12 are completed, subjects will proceed directly to Visit 1b (on the same day). Evaluations completed at Week 12 will be used for Visit 1b and will become the new Baseline for Phase 1b.
Subjects will receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects will follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye will be administered on the same day (Visit 1b). Subjects will come to the site 12 weeks after their initial treatment. Afterwards, subjects will proceed to Phase 2.
Phase 2 and Exit visit:
Phase 2 will occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group (after Phase 1b).
All these subjects will come to the site 24 weeks, and 52 weeks after their initial treatment. All subjects will be followed for 52 weeks after their initial treatment with RHA® Redensity Eye.
Subjects will be offered retreatment (52 weeks after their initial treatment). Retreatment will be administered if the TI deems it to be appropriate and the subject agrees. If the subject does not receive retreatment, Visit at 52 weeks after initial treatment will become the Exit visit.
If the subject receives retreatment, the subjects will come to the site 12 weeks after retreatment for follow-up and safety assessments. This will be the Exit visit.
Inclusion Criteria:
Exclusion Criteria: