Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04577898 · ClinicalTrials.gov registry record · NA
RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows
A NA study, sponsored by Teoxane.
- Completed
- Registry status
- NA
- Development phase
- 248
- Enrollment target
NCT04577898 is a NA study that has completed, run by Teoxane. The registered enrollment target is 248 participants.
The verdict
NCT04577898, a NA study, has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- NA
- Development phase
- 248 participants
- Enrollment target
Study 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.
Interventions
- DEVICE RHA® Redensity Eye
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2025-02-14 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04577898
The ClinicalTrials.gov registry entry for NCT04577898 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teoxane, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RHA® Redensity Eye is the first listed.
NCT04577898 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04577898 about?
NCT04577898 is a clinical study titled "RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows". 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 l...
What is the current status of trial NCT04577898?
This trial is currently completed. It is a NA study. The enrollment target is 248 participants. The study started on 2020-12-02. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT04577898?
The interventions under investigation include: RHA® Redensity Eye (DEVICE).
Who is sponsoring clinical trial NCT04577898?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.