Effect of a New HA Filler in Correcting Nasolabial Fold

Not Applicable

Completed

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

• Registration Number: NCT06574750
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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 Timeline

• Study Start: 2021-10-16
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Juvederm	JuvedermⓇ (Q-Med AB, Uppsala, Sweden)	The left/right assignment was sealed in a nontransparent envelop.
New HA filler (Curea)	CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)	The left/right assignment was sealed in a nontransparent envelop.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of