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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: Completed NA study, sponsored by Teoxane.
NCT04577898 is a NA study that has completed, run by Teoxane. The registered enrollment target is 248 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
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 |
What the finished NCT04577898 record still lists
NCT04577898 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which RHA® Redensity Eye is the first listed.
NCT04577898 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04577898's enrollment target sits among peer trials
248 434th of 2000 higher than 1,565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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