Effect of a New HA Filler in Correcting Nasolabial Fold

New HA Filler Versus Juvederm for Nasolabial Fold Correction

The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction

Study Overview

• Status: Completed
• Conditions: Aging Problems
• Intervention / Treatment: Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea); Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)

Detailed Description

A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides

Exclusion Criteria:

• patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler
• participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study
• participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study
• participants who had been injected with other biomaterials, including HA within 6 months before the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New HA filler (Curea); The left/right assignment was sealed in a nontransparent envelop.	Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea); Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.; Other Names: experimental group
Active Comparator: Juvederm; The left/right assignment was sealed in a nontransparent envelop.	Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden); Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.; Other Names: active control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS	Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)	at 24 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAIS	Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse).	at 24 weeks after treatment
Adverse events related to the procedure	Patients were required to report any adverse events up to 24 weeks	up to 24 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Bo Ri Kim, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: E-2105/684-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No