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

Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Device: VOLNEWMER

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Dongjak-gu, Seoul, Korea, Republic of, 06974
      • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects who are aged 19 to under 65 at the time of consent.
• Subjects who seek improvement in facial skin elasticity (both cheeks).
• Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
• Subjects who provide written consent and commit to full trial participation.

Exclusion Criteria:

• Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
• Subjects with inappropriate skin conditions or treatment history
• Subjects with allergies or predispositions
• Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
• Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
• Subjects deemed inappropriate by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOLNEWMER; Each subject will undergo a procedure using VOLNEWMER's F-Tip or V-tip electrode with either the Basic mode or Easy mode, depending on the treatment area.	Device: VOLNEWMER; Monopolar radiofrequency device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cutometer R7 values	The change in Cutometer R7 values measured on the cheeks at 12 weeks after the application of the investigational medical device compared to baseline will be evaluated.	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cutometer R7 values	The change in Cutometer R7 values measured on the cheeks at 8 weeks after the application of the investigational medical device compared to baseline will be evaluated.	baseline, 8 weeks
Global Aesthetic Improvement Scale (GAIS)	The Global Aesthetic Improvement Scale (GAIS) assessed by both the investigator and the subjects at 4, 8, and 12 weeks after the application of the investigational medical device will be evaluated.; Minimum and Maximum Values: The GAIS ranges from -1 (worse) to +3 (excellent improvement).; Outcome Interpretation: Higher scores indicate a better aesthetic outcome.	4 weeks, 8 weeks, 12 weeks
Numeric Rating Scale (NRS) for Pain	The subject's pain level at the treatment site will be evaluated using the Numeric Rating Scale (NRS) at the baseline visit and at 4, 8, and 12 weeks after the application of the investigational medical device.; Minimum and Maximum Values: The NRS ranges from 0 (no pain) to 10 (worst imaginable pain).; Outcome Interpretation: Higher scores indicate worse pain.	Baseline, 4 weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: CLASSYS Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Skin Elasticity; MRF; VOLNEWMER; Monopolar radiofrequency device; Skin Tightening; Facial skin treatment
• Other Study ID Numbers: VM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No