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.
Description
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.
Eligibility
Inclusion Criteria:
- Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
- Participants whose average Cutometer R7 value for both checks is ≤0.6.
- Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
- Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
- Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
- 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:
- 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.
- Participants who have scars or open lesions at the investigational medical
