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.
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 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 device application area that may influence the conduct or results of the study.
Participants who have metal stents or implants at the investigational medical device application area.
Participants with severe solar elastosis.
Parallel
Test arm
DeviceParticipants receive treatment with the investigational device VOLNEWMER applied to both cheeks.
Control arm
DeviceParticipants receive treatment using the device in training mode that does not deliver radiofrequency energy.
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.
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.
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.
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.
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.
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CLASSYS Inc.
Lead sponsor
Chung-Ang University Hospital
Collaborator
