Effect of a New HA Filler in Correcting Nasolabial Fold

NCT06574750 | Completed DMC

• 1 other identifier: E-2105/684-001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging Problems

Outcome Measures

Primary Outcomes (1)

• WSRS

  Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)

  at 24 weeks after treatment

Secondary Outcomes (2)

• GAIS

  at 24 weeks after treatment

• Adverse events related to the procedure

  up to 24 weeks

Study Arms (2)

New HA filler (Curea)

EXPERIMENTAL

The left/right assignment was sealed in a nontransparent envelop.

Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)

Juvederm

ACTIVE COMPARATOR

The left/right assignment was sealed in a nontransparent envelop.

Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)

Interventions

CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) DRUG

Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.

Also known as: experimental group

New HA filler (Curea)

JuvedermⓇ (Q-Med AB, Uppsala, Sweden) DRUG

Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.

Also known as: active control group

Juvederm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Related Publications (1)

• Kim BR, Shin JW, Kim DW, Choung JJ, Jang Y, Lee SH, Seo BS, Huh CH. Efficacy and Safety of New Hyaluronic Acid Filler for Nasolabial Fold Correction: A Double-Blind, Randomized Trial. Plast Reconstr Surg. 2026 Feb 1;157(2):249-256. doi: 10.1097/PRS.0000000000012320. Epub 2025 Jul 21.

  PMID: 40707029 DERIVED

MeSH Terms

Interventions

Long-Term Synaptic Depression

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bo Ri Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: October 16, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)