A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

Correction of Nasolabial Folds Clinical Trial

Official title:

A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106751
• Other study ID #: LG-HACL033
• Status: Completed
• Phase: Phase 4
• Start date: October 21, 2021
• Est. completion date: April 3, 2023

Study information

• Verified date: August 2023
• 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 Classic plus on NLF.

Description:

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 3, 2023
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Male or female 21 years or above age.
• 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
• Agree to use proper contraception as guided in the protocol.
• Signed for Informed Consent.

Exclusion Criteria:

• have received permanent facial implants anywhere in the face or neck or planning during the investigation.
• have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
• have undergone semi-permanent filler in lower face
• have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
• Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
• Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
• have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

Device:
• Hyaluronic acid dermal filler
Hyaluronic acid dermal filler used for facial volume or wrinkle correction

Locations

Country	Name	City	State
Germany	LG Chem investigational site 01	Darmstadt

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 Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.	To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).	24 weeks from baseline
Primary	Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.	To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as = 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.	24 weeks from baseline