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

Lip Augmentation Clinical Trial

Official title:

A 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04299295
• Other study ID #: LG-HACL023
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 118
• Est. completion date: March 1, 2021
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lip Augmentation

Intervention

Device:
• YVOIRE Y-Solution 360
Hyaluronic acid dermal filler
• Juvéderm VOLBELLA
Hyaluronic acid dermal filler

Locations

Country	Name	City	State
Germany	Haut-und Lasercentrum Potsdam	Potsdam

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.	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).	12 weeks from baseline
Primary	Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.	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.	12 weeks from baseline
Secondary	Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.	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).	2, 4, 12, 24 weeks from baseline
Secondary	Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.	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).	2, 4, 12, 24 weeks from baseline
Secondary	Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.	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).	2, 4, 12, 24 weeks from baseline
Secondary	Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.	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).	2, 4, 12, 24 weeks from baseline
Secondary	Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.	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).	2, 4, 12, 24 weeks from baseline