Innovative Facial Contouring Using a Monopolar Radiofrequency Device With Continuous Water Cooling: An Integrated Clinical and Preclinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Jawline lifting
Study Overview
Brief Summary
The goal of this clinical trial is to assess whether a single RF-CWC (radiofrequency - continous water cooling) session can produce significant improvements in jawline contour and facial volume in women aged 38-50 years over 8 weeks. The main questions it aims to answer are:
- Can one session of RF-CWC elevate the jawline after 8 weeks?
- Can one session of RF-CWC contour the lower face after 8 weeks? Researchers will compare the jawline lifting effect and mandibular volume at 2, 4, and 8 weeks to baseline values.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 38 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 38-50 years
- •Agreed to abstain from any dermatological procedures, including facial lifting, during the study
- •Able to adhere to the study protocol.
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Failure to comply with contraception
- •Facial lesions
- •Hypersensitivity
- •Inflammatory or infectious facial conditions
- •Recent use of systemic steroids or phototherapy (within 1 month)
- •Recent cosmetic procedures (within 3 months)
- •Any condition deemed unsuitable by the investigator.
Outcomes
Primary Outcomes
Jawline lifting
Time Frame: From baseline to the end of the study at 8 weeks
Jawline lifting was evaluated using Morpheus3D® (Morpheus Co., Ltd., Gyeonggi, Republic of Korea), an LED-based 3D facial imaging system. Jawline lifting was measured as the curved distance (mm) from the chin to the earlobe; a decrease in length indicated improvement.
Facial volume
Time Frame: From baseline to the end of the study at 8 weeks
Facial volume was evaluated using Morpheus3D® (Morpheus Co., Ltd., Gyeonggi, Republic of Korea), an LED-based 3D facial imaging system. Facial volume (ml) was assessed for two regions: the midface (between the eyes and the area from philtrum to nose), where an increase indicated volumization, and the lower face (philtrum to chin), where a decrease indicated contouring.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ngoc Ha Nguyen
Principal Investigator
Yonsei University