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NCT03092219 · ClinicalTrials.gov registry record · NA
RHA Redensity - Perioral Rhytids
A NA study, sponsored by Teoxane.
- Completed
- Registry status
- NA
- Development phase
- 202
- Enrollment target
NCT03092219 is a NA study that has completed, run by Teoxane. The registered enrollment target is 202 participants.
The verdict
NCT03092219, a NA study, has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- NA
- Development phase
- 202 participants
- Enrollment target
Study Summary
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment). The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study. The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness. This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study. Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the "No-Treatment" control group (ratio 3:1). The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results. The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment). All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropri
Interventions
- DEVICE TEOSYAL RHA Redensity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2016-12-20 |
| Est. Completion | 2019-01-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03092219
The ClinicalTrials.gov registry entry for NCT03092219 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 202 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 TEOSYAL RHA Redensity is the first listed.
NCT03092219 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03092219 about?
NCT03092219 is a clinical study titled "RHA Redensity - Perioral Rhytids". Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment). ...
What is the current status of trial NCT03092219?
This trial is currently completed. It is a NA study. The enrollment target is 202 participants. The study started on 2016-12-20. Estimated completion is 2019-01-08.
What interventions are being tested in trial NCT03092219?
The interventions under investigation include: TEOSYAL RHA Redensity (DEVICE).
Who is sponsoring clinical trial NCT03092219?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
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