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

NCT06305520 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-15

No results posted yet for this study

Summary

Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.

Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design

Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)

Population: Number of subject 100

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

Conditions

  • Nasal Disease
  • Nasal 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).

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • Bioplus

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305520 on ClinicalTrials.gov