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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: Completed NA study, sponsored by Teoxane.
NCT04754646 is a NA study that has completed, run by Teoxane. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Non-inferiority of RHA®4 injected with a cannula to the change from Baseline for subjects treated with RHA®4 injected with a needle at 12 weeks after last treatment (initial or touch-up; up to 16 weeks post-baseline)) as assessed by the BLE using the NLF-WSRS. NLF-WSRS (Nasolabial Folds - Wrinkle Severity Rating Scale) is a proprietary validated 5-grade scale with 1 being "Absent" and 5 being "Extreme". An NLF-WSRS change of \>1 grade will be considered clinically significant.
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 |
What the finished NCT04754646 record still lists
NCT04754646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04754646's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 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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