Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

NCT03738020 | Completed Results

• 1 other identifier: LG-HACL008
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, 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

EXPERIMENTAL

Device: HA IDF (YVOIRE classic)

Restylane

ACTIVE COMPARATOR

Device: Restylane

Interventions

HA IDF (YVOIRE classic) DEVICE

Treatment with HA IDF

HA IDF

Restylane DEVICE

Treatment with Restylane

Restylane

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 and 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.

You may not qualify if:

• Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
• Patients with a disorder in autoimmune system
• 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 material within 3 months prior to the study (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

Results Point of Contact

• Title: Study Leader
• Organization: LG Chem

sodam@lgchem.com

82-2-6987-4148

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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

Model Details: IND approved from KFDA

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Study Start: January 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-11