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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorCLASSYS Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Test arm
  • Control arm

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

CLASSYS Inc.

Lead sponsor

Chung-Ang University Hospital

Collaborator