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Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening

NCT06816069 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-18

No results posted yet for this study

Summary

Objective:

The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.

Research Questions:

1. Does the VOLNEWMER device improve skin elasticity?
2. Is the safety profile of the VOLNEWMER device acceptable?

Subject Procedures:

Subjects will:

* Receive a single treatment session using the VOLNEWMER device.
* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.

The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.

Conditions

  • Skin Aging

Interventions

DEVICE

VOLNEWMER

Monopolar radiofrequency device

Sponsors & Collaborators

  • CLASSYS Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-03-01
Completion
2025-03-01

Countries

  • South Korea

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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 NCT06816069 on ClinicalTrials.gov