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NCT04069585 · ClinicalTrials.gov registry record · NA
RHA® Redensity With New Anesthetic Agent - Perioral Rhytids
A NA study, sponsored by Teoxane.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04069585 is a NA study that has completed, run by Teoxane. The registered enrollment target is 30 participants.
The verdict
NCT04069585, a NA study, has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.
Interventions
- DEVICE RHA® Redensity with new anesthetic agent
- DEVICE RHA® Redensity with lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2020-11-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04069585
The ClinicalTrials.gov registry entry for NCT04069585 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 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 RHA® Redensity with new anesthetic agent is the first listed.
NCT04069585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04069585 about?
NCT04069585 is a clinical study titled "RHA® Redensity With New Anesthetic Agent - Perioral Rhytids". This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At scr...
What is the current status of trial NCT04069585?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-10-30. Estimated completion is 2020-11-09.
What interventions are being tested in trial NCT04069585?
The interventions under investigation include: RHA® Redensity with new anesthetic agent (DEVICE), RHA® Redensity with lidocaine (DEVICE).
Who is sponsoring clinical trial NCT04069585?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
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