Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540913
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2020-08-28
Brief Title:
RHA 3 Versus Restylane-L for Lip Augmentation
Sponsor:
Teoxane SA
Organization:
Teoxane SA
Study Overview
Official Title:
A Controlled Randomized Double-blinded Between-subject Multicenter Prospective Clinical Study to Evaluate Safety and Effectiveness of RHA 3 Versus Restylane-L for Lip Augmentation
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects 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 subjects 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 31 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
At screening the treating investigator TI will evaluate the subjects 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 subjects 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 31 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None