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

NCT06816069 | Active Not Recruiting

• 1 other identifier: VM-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

VOLNEWMER; Monopolar radiofrequency device; MRF; Skin Tightening; Facial skin treatment; Skin Elasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Cutometer R7 values

  baseline, 8 weeks

• Global Aesthetic Improvement Scale (GAIS)

  4 weeks, 8 weeks, 12 weeks

• Numeric Rating Scale (NRS) for Pain

  Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (1)

VOLNEWMER

EXPERIMENTAL

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

Interventions

VOLNEWMER DEVICE

Monopolar radiofrequency device

VOLNEWMER

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CLASSYS Inc.: lead

Study Sites (1)

Chung-Ang University Hospital

Dongjak-gu, Seoul, 06974, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: November 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)