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

NCT03738007 | Completed

• 1 other identifier: LG-HACL009
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Temporary Correction of Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. 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)

Study Arms (2)

HA IDF II

EXPERIMENTAL

Device: HA IDF II

Perlane

ACTIVE COMPARATOR

Device: Perlane

Interventions

HA IDF II DEVICE

Treatment with HA IDF II (YVOIRE volume)

HA IDF II

Perlane DEVICE

Treatment with Perlane

Perlane

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: Women in 30\~55 years.
• 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
• 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.

You may not qualify if:

• Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
• Those with a history of severe allergy
• Those with hypertrophic scar or a history of kelloid
• Patients with an autoimmune disease
• Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
• Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
• 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).
• Patients with a malignant tumor
• Women in pregnancy or lactation
• Hepatitis carriers or VDRL/HIV positive patients
• Those with a hypersensitivity to the investigational medical device of this study
• Other persons including those considered as difficult to perform this study by the principal investigator

Sponsors & Collaborators

• LG Life Sciences: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 26, 2018

Record last verified: 2018-11