Facial Contouring With Monopolar RF and Continuous Water Cooling

Yonsei University22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging Sagging Skin Laxity; Skin

Interventions

RF-CWCDEVICE

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.

Eligibility

Sex: FEMALEMin age: 38 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Global Medical Evaluation Academy

Seoul, South Korea

Outcomes

Primary Outcomes

Jawline lifting

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.

Time frame: From baseline to the end of the study at 8 weeks

Facial volume

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.

Time frame: From baseline to the end of the study at 8 weeks

Data from ClinicalTrials.gov

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