Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device

CLASSYS Inc.96 enrolled

Overview

The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.

This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lifting Efficacy

Interventions

Test armDEVICE

Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.

Control armDEVICE

Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent. 2. Participants whose average Cutometer R7 value for both checks is ≤0.6. 3. Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy. 4. Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period. 5. Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study 6. Participants who have adequately understood the objectives and procedures of the clinical trial, voluntarily consent in writing to participate, and are able to complete the study as required. Exclusion Criteria: 1. Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study. 2. Participants who have scars or open lesions at the investigational medical

Locations (1)

Classys Inc

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change in Cutometer R7 values

Change from baseline in Cutometer R7 value at Week 12 following treatment with the investigational medical device, as assessed by an independent evaluator.

Time frame: 12 weeks

Secondary Outcomes

Change in Cutometer R7 values

Change from baseline in Cutometer R7 value at 8 weeks after application of the investigational medical device, as assessed by an independent evaluator.

Time frame: 8 weeks

Percentage change from baseline in Cutometer R7 value

Percent change from baseline in Cutometer R7 value at Weeks 8 and 12 after application of the investigational medical device, as assessed by an independent evaluator.

Time frame: week 8 and week 12

Global Aesthetic Improvement Scale (GAIS)

Global Aesthetic Improvement Scale(GAIS) scores at Weeks 4, 8, and 12 after application of the investigational medical device, as assessed by the investigator.

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

Global Aesthetic Improvement Scale(GAIS) assessment

Global Aesthetic Improvement Scale(GAIS) scores assessed by participants at 4, 8, and 12 weeks following treatment with the investigational medical device.

Time frame: 4, 8, and 12 weeks

Central Contacts

Jihye Min

CONTACT

82-2-6313-2242 mins0131@classys.com

Data from ClinicalTrials.gov

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