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NCT04754646 · ClinicalTrials.gov registry record · NA
RHA® 4 NLF Cannula
A NA study, sponsored by Teoxane.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT04754646 is a NA study that has completed, run by Teoxane. The registered enrollment target is 50 participants.
The verdict
NCT04754646, a NA study, has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator (BLE) using the Teoxyne NLF-WSRS (proprietary, validated NLF Wrinkle Severity Rating Scale) at 12 weeks from last treatment. At Visit 1 (Week 0), RHA®4 injected with cannula will be administered in a random sequence (first or second injection) and side of the face (left or right NLF) and RHA®4 injected with a sharp needle will be administered to the other side. The TI will administer study devices and will be unblinded to treatment allocation. Blinded assessments of effectiveness will be conducted by the BLE (Blinded Live Evaluator). 4 weeks following initial treatment, subjects will attend Visit 2 and receive, if necessary, touch-up treatments (using a needle or cannula as per the subject's initial treatment assignment). Subjects receiving touch-up treatments at Week 4 (Visit 2) will attend a new Visit 2b (4 weeks following touch-up treatment); subject not receiving touch-up treatment will not attend Visit 2b. After each injection (initial treatment or touch-up), subjects will receive a safety follow-up call from the study site within 3-day. Subjects will then attend scheduled in-office study visits at 8 (Visit 3) and 12 weeks (Visit 4) following last treatment (initial treatment or touch-up) where safety and effectiveness assessments will be conducted.
Interventions
- DEVICE Split-face injection of RHA® 4 with a cannula into a single NLF.
- DEVICE Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2021-11-29 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04754646
The ClinicalTrials.gov registry entry for NCT04754646 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 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 Split-face injection of RHA® 4 with a cannula into a single NLF. is the first listed.
NCT04754646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04754646 about?
NCT04754646 is a clinical study titled "RHA® 4 NLF Cannula". This is a randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determi...
What is the current status of trial NCT04754646?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2021-03-15. Estimated completion is 2021-11-29.
What interventions are being tested in trial NCT04754646?
The interventions under investigation include: Split-face injection of RHA® 4 with a cannula into a single NLF. (DEVICE), Split-face injection of RHA® 4 with a needle (TSK 27G x ½") into the contralateral NLF. (DEVICE).
Who is sponsoring clinical trial NCT04754646?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
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