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

CLASSYS Inc.

Status: Active, not recruiting

Conditions: Skin Aging

Treatments: Device: VOLNEWMER

Study type: Interventional

Funder types: Industry

Identifiers

NCT06816069

VM-01

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

VOLNEWMER

Experimental group

Description:

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.

Treatment:

Device: VOLNEWMER