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

NCT ID: NCT03738007

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HA IDF II

Group Type: EXPERIMENTAL

HA IDF II

Intervention Type: DEVICE

Treatment with HA IDF II (YVOIRE volume)

Perlane

Group Type: ACTIVE_COMPARATOR

Perlane

Intervention Type: DEVICE

Treatment with Perlane

Interventions

HA IDF II

Treatment with HA IDF II (YVOIRE volume)

Intervention Type: DEVICE

Perlane

Treatment with Perlane

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LG-HACL009

Identifier Type: -

Identifier Source: org_study_id