Facial Contouring With Monopolar RF and Continuous Water Cooling

NCT07317089 | Completed

• 1 other identifier: GIRB-23614-PM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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. 1.Can one session of RF-CWC elevate the jawline after 8 weeks?
2. 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.

Conditions

Sagging Skin; Skin Aging; Laxity; Skin

Keywords

Monopolar radiofrequency; continuous water cooling; skin rejuvenation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From baseline to the end of the study at 8 weeks

Study Arms (1)

Treatment arm A

EXPERIMENTAL

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.

Device: RF-CWC

Interventions

RF-CWC DEVICE

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.

Treatment arm A

Eligibility Criteria

• Age: 38 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Global Medical Evaluation Academy

Seoul, South Korea

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 5, 2026
• Study Start: July 1, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)