Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection

A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection

This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.

Study Overview

• Status: Completed
• Conditions: Temporary Correction of Wrinkles
• Intervention / Treatment: Device: HA IDF II; Device: Perlane

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: Women in 30~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
3. Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
2. Those with a history of severe allergy
3. Those with hypertrophic scar or a history of kelloid
4. Patients with an autoimmune disease
5. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
6. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
7. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
8. Patients with a malignant tumor
9. Women in pregnancy or lactation
10. Hepatitis carriers or VDRL/HIV positive patients
11. Those with a hypersensitivity to the investigational medical device of this study
12. Other persons including those considered as difficult to perform this study by the principal investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA IDF II	Device: HA IDF II; Treatment with HA IDF II (YVOIRE volume)
Active Comparator: Perlane	Device: Perlane; Treatment with Perlane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.	Wrinkle Severity Rating Scale (WSRS); Absent: no visible fold; continuous line; Mild: Shallow but visible fold with slight indentation; minor facial feature; Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.; Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched; Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone	Week 26 (Visit 7)

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: LG-HACL009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No