To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

Not Applicable

Terminated

• Conditions: Lip Augmentation
• Interventions: Device: YVOIRE Y-Solution 360; Device: Juvéderm VOLBELLA

• Registration Number: NCT04299295
• Lead Sponsor: LG Chem

Brief Summary

A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

Detailed Description

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Status Verified: 2020-06
• Study Start: 2020-06-05
• Primary Completion: 2020-12-07
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Male or female 18 years or above age.
• 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
• Agree to use proper contraception as guided in the protocol.
• Signed for Informed Consent.

Exclusion Criteria

• have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
• who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
• have undergone oral surgery within 6 weeks
• have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
• have undergone semi-permanent filler in lower face within 24 months
• have undergone temporary dermal filler treatment in the lower face within 12 months
• Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
• Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
• have used lip plumping products within 10 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE Y-Solution 360	YVOIRE Y-Solution 360	Hyaluronic acid dermal filler
Juvéderm VOLBELLA	Juvéderm VOLBELLA	Hyaluronic acid dermal filler

Primary Outcome Measures

Name	Time	Method
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.	12 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated.
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.	12 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced).

Secondary Outcome Measures

Name	Time	Method
Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.	2, 4, 12, 24 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.	2, 4, 12, 24 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.	2, 4, 12, 24 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the responder rate (defined as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.	2, 4, 12, 24 weeks from baseline	To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the responder rate (as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.	2, 4, 12, 24 weeks from baseline	To measure the satisfaction of YVOIRE Y-Solution 360 the GAIS evaluation will be performed by subject and investigator. GAIS Grade are -2 (Much Worse), -1 (Worse), 0 (No change), 1 (Improved), and 2 (Much improved).

Trial Locations

Locations (1)

Haut-und Lasercentrum Potsdam; 🇩🇪 Potsdam, Germany