Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06816069

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Skin Aging

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital

Dongjak-gu, Seoul, 06974, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VOLNEWMER

Device

Monopolar radiofrequency device

Primary outcomes

  1. Change in Cutometer R7 values

    Time frame: baseline, 12 weeks

    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.

Secondary outcomes

  1. Change in Cutometer R7 values

    Time frame: baseline, 8 weeks

    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.

  2. Global Aesthetic Improvement Scale (GAIS)

    Time frame: 4 weeks, 8 weeks, 12 weeks

    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.

  3. Numeric Rating Scale (NRS) for Pain

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

CLASSYS Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.