Laxity; Skin, Sagging Skin, Skin Aging
Conditions
Keywords
Monopolar radiofrequency, continuous water cooling, skin rejuvenation
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: 1. Can one session of RF-CWC elevate the jawline after 8 weeks? 2. 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.
Interventions
DEVICERF-CWC
Participants underwent a single RF-CWC treatment on Day 0 after eligibility screening and baseline assessments. Treatment was applied using two distinct modes based on anatomical regions. The static mode was administered to the outer facial areas, while the sliding mode was applied to the central facial areas. This approach allowed for region-specific assessment of volumetric changes corresponding to each treatment mode. Follow-up visits were conducted at weeks 2, 4, and 8.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jawline lifting | 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 | 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. |
Countries
South Korea
Outcome results
None listed