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NCT05133739 · ClinicalTrials.gov registry record
RHA®4 for Midface Volume Deficiency
A clinical trial, sponsored by Teoxane.
- Completed
- Registry status
- 201
- Enrollment target
NCT05133739 is a clinical trial that has completed, run by Teoxane. The registered enrollment target is 201 participants.
The verdict
NCT05133739 has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- 201 participants
- Enrollment target
Study 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 th
Interventions
- DEVICE injection of RHA®4 in Midface
- DEVICE injection of Comparator Product in Midface
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2024-01-29 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05133739
The ClinicalTrials.gov registry entry for NCT05133739 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 201 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 2 interventions - of which injection of RHA®4 in Midface is the first listed.
NCT05133739 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05133739 about?
NCT05133739 is a clinical study titled "RHA®4 for Midface Volume Deficiency". 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 treatin...
What is the current status of trial NCT05133739?
This trial is currently completed. The enrollment target is 201 participants. The study started on 2021-10-29. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT05133739?
The interventions under investigation include: injection of RHA®4 in Midface (DEVICE), injection of Comparator Product in Midface (DEVICE).
Who is sponsoring clinical trial NCT05133739?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
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