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

• ClinicalTrials.gov Identifier: NCT03738020
• Recruitment Status: Completed
• First Posted: November 13, 2018
• Results First Posted: December 18, 2019
• Last Update Posted: December 18, 2019
• Sponsor: LG Life Sciences
• Information provided by (Responsible Party): LG Life Sciences

Tracking Information

• First Submitted Date: November 9, 2018
• First Posted Date: November 13, 2018
• Results First Submitted Date: November 27, 2018
• Results First Posted Date: December 18, 2019
• Last Update Posted Date: December 18, 2019
• Actual Study Start Date: January 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2019)

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 [ Time Frame: Week 26 (Visit 7) ]

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

• Original Primary Outcome Measures (submitted: November 9, 2018): Average Wrinkle Severity Rating Scale (WSRS) evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device [ Time Frame: Week 26 (Visit 7) ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection
• Official Title: A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of HA IDF Versus Restylane in Nasolabial Fold Intradermal Injection
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

IND approved from KFDA

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Temporary Correction of Wrinkles

Intervention

• Device: HA IDF (YVOIRE classic)
  Treatment with HA IDF
• Device: Restylane
  Treatment with Restylane

Study Arms

• Experimental: HA IDF
  Intervention: Device: HA IDF (YVOIRE classic)
• Active Comparator: Restylane
  Intervention: Device: Restylane

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2018): 58
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 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.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
2. Patients with a disorder in autoimmune system
3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.
5. 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).
6. Patients with a malignant tumor
7. Women in pregnancy or lactation
8. Hepatitis carriers or VDRL/HIV positive patients
9. Those with a hypersensitivity to the investigational medical device of this study
10. Other persons including those considered as difficult to perform this study by the principal investigator

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03738020
• Other Study ID Numbers: LG-HACL008
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: LG Life Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: LG Life Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: LG Life Sciences
• Verification Date: November 2019