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NCT04540913 · ClinicalTrials.gov registry record
RHA® 3 Versus Restylane-L® for Lip Augmentation
A clinical trial of Lip and Lip Augmentation, sponsored by Teoxane.
- Completed
- Registry status
- 202
- Enrollment target
- 1
- Study location
NCT04540913 is a study of Lip and Lip Augmentation that has completed, run by Teoxane. The registered enrollment target is 202 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04540913, a study of Lip and Lip Augmentation, has completed, sponsored by Teoxane.
- COMPLETED
- Registry status
- 202 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up). At screening, the treating investigator (TI) will evaluate the subject's lip fullness using the validated Teoxane Lip Fullness Scale (5-grade) for eligibility of the subject for the study. At screening, the blinded live evaluator (BLE) will evaluate the subject's lip fullness using the TLFS to confirm eligibility and to establish a pre-treatment score for assessment of effectiveness. Enrolled subjects will be randomly assigned in a 3:1 ratio to either the RHA® 3 or the Restylane-L® treatment group. Subjects will be blinded to the study treatment. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection. The study duration was extended from 36 to 52 weeks once all subjects had already been enrolled. Nearly 60% of the subjects consented to extend the study to 52 weeks before being eligible for repeat treatment. All data are presented up to 52 weeks (as well as 4 more weeks follow-up after retreatment at 36 or 52 weeks). Subjects will be followed for 36 to 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 3, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented. The subject will then be followed for an additional 4 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (36 or 52 weeks after the last treatment) will be considered the study Exit vis
Conditions Studied
Interventions
- DEVICE Restylane-L
- DEVICE RHA 3
Study Locations (1)
Florida
- United States, Florida - Bradenton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2022-09-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04540913
The ClinicalTrials.gov registry entry for NCT04540913 describes a study currently listed as completed, categorized as an unspecified phase. 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 2 conditions, with Lip appearing as the primary indexed condition, and to 2 interventions - of which Restylane-L is the first listed.
NCT04540913 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04540913 about?
NCT04540913 is a clinical study titled "RHA® 3 Versus Restylane-L® for Lip Augmentation". This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up). At screening, the treating investigator (TI) will evaluate the subject...
What is the current status of trial NCT04540913?
This trial is currently completed. The enrollment target is 202 participants. The study started on 2020-10-22. Estimated completion is 2022-09-07.
What conditions does trial NCT04540913 study?
This clinical trial studies the following conditions: Lip, Lip Augmentation.
What interventions are being tested in trial NCT04540913?
The interventions under investigation include: Restylane-L (DEVICE), RHA 3 (DEVICE).
Who is sponsoring clinical trial NCT04540913?
This trial is sponsored by Teoxane, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04540913 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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