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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 10, 2023

Primary Completion Date

September 30, 2024

Study Completion Date

October 31, 2024

Conditions
Nasal DiseaseNasal Surgery
Interventions
DEVICE

Investigational medical device (SkinPlus-HYAL Implant Lidocaine)

\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).

DEVICE

Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)

\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).

Trial Locations (1)

03080

Seoul National University Hospital, Seoul

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Seoul National University Hospital

OTHER

collaborator

Asan Medical Center

OTHER

collaborator

Soonchunhyang University Hospital

OTHER

lead

Bioplus

INDUSTRY

NCT06305520 - Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds | Biotech Hunter | Biotech Hunter