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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Temporary Correction of Wrinkles Device: HA IDF (YVOIRE classic) Device: Restylane Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: IND approved from KFDA
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: HA IDF Device: HA IDF (YVOIRE classic)
Treatment with HA IDF
Active Comparator: Restylane Device: Restylane
Treatment with Restylane


Outcome Measures
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Primary Outcome Measures :
  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 [ 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT03738020    
Other Study ID Numbers: LG-HACL008
First Posted: November 13, 2018    Key Record Dates
Results First Posted: December 18, 2019
Last Update Posted: December 18, 2019
Last Verified: November 2019

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