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

N/AActive Not RecruitingNCT06816069

CLASSYS Inc.36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: baseline, 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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