Enrolling By Invitation NA INTERVENTIONAL 2-arm NCT06305520

Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds (BPLUS-02)

Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds

Sponsor: Asan Medical Center

Conditions Nasal Disease Nasal Surgery

Interventions Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) Investigational medical device (SkinPlus-HYAL Implant Lidocaine)

Updated 4 times since 2024 Last updated: Mar 13, 2024 Started: Mar 10, 2023 Primary completion: Sep 30, 2024 Completion: Oct 31, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Nasal Disease and Nasal Surgery and is currently ongoing. Asan Medical Center leads this study, which shows 4 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

4 versions recorded

Sep 2025 — Present [monthly]

Enrolling By Invitation NA
Sep 2024 — Sep 2025 [monthly]

Enrolling By Invitation NA
Jul 2024 — Sep 2024 [monthly]

Enrolling By Invitation NA
Apr 2024 — Jul 2024 [monthly]

Enrolling By Invitation NA

First recorded

Mar 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Asan Medical Center
Bioplus
Seoul National University Hospital
Soonchunhyang University Hospital

Data source: Bioplus

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Seoul, South Korea