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NCT06378086 · ClinicalTrials.gov registry record · NA
RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)
A NA study of Pain and Aging, sponsored by Teoxane.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT06378086 is a NA study of Pain and Aging that is active but no longer recruiting, run by Teoxane. The registered enrollment target is 20 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06378086, a NA study of Pain and Aging, is active but no longer recruiting, sponsored by Teoxane.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
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 Principal Investigator (PI) 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 PI 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 effectiveness 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
Study Locations (3)
Alabama
- United States - Birmingham
New York
- United States, New York - New York
Other
- Puerto Rico - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2025-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06378086
The ClinicalTrials.gov registry entry for NCT06378086 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (93% lower). The listed sponsor is Teoxane, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which RHA® Redensity with new anesthetic agent is the first listed.
NCT06378086 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, New York, Other.
Frequently Asked Questions
What is clinical trial NCT06378086 about?
NCT06378086 is a clinical study titled "RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)". 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 NCT06378086?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-06-11. Estimated completion is 2025-09.
What conditions does trial NCT06378086 study?
This clinical trial studies the following conditions: Pain, Aging.
What interventions are being tested in trial NCT06378086?
The interventions under investigation include: RHA® Redensity with new anesthetic agent (DEVICE), RHA® Redensity with lidocaine (DEVICE).
Who is sponsoring clinical trial NCT06378086?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06378086 being conducted?
This trial has 3 study locations across Alabama, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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