RHA® 3 Versus Restylane-L® for Lip Augmentation

Status Completed

Clinical Trial 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 visit. For subjects with re-treatment, the Exit visit will be 4 weeks after the re-treatment. The TI will conduct safety and effectiveness evaluations at each study visit (up to 36 weeks or 52 (if applicable) weeks after the last treatment, and 4 weeks after re treatment) or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04540913
Study type	Interventional
Source	Teoxane SA
Contact
Status	Completed
Phase
Start date	October 22, 2020
Completion date	September 7, 2022

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03967444` - Study to Evaluate Satisfaction After Treatment With Kysse	N/A
Terminated	`NCT04299295` - To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.	N/A
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Terminated	`NCT04029545` - A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation	Phase 3
Active, not recruiting	`NCT05342753` - Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects	N/A
Completed	`NCT00935272` - Safety/Efficacy Study of Restylane® in Lip Augmentation	N/A
Recruiting	`NCT05314504` - Clinical Investigation of YVOIRE Y-Solution 360 for Lip Augmentation in China	N/A
Completed	`NCT04029519` - A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation	Phase 3
Completed	`NCT03796728` - A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation	Phase 4
Completed	`NCT01197495` - Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.