Facial Contouring With Monopolar RF and Continuous Water Cooling

NCT ID: NCT07317089

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-09-13

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.

Conditions

Skin Aging; Sagging Skin; Laxity; Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm A

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.

Group Type: EXPERIMENTAL

RF-CWC

Intervention Type: 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.

Interventions

RF-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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Ngoc Ha Nguyen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Global Medical Evaluation Academy

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GIRB-23614-PM

Identifier Type: -

Identifier Source: org_study_id