Facial Contouring With Monopolar RF and Continuous Water Cooling

Yonsei University

Status: Completed

Conditions: Laxity; Skin; Skin Aging; Sagging Skin

Treatments: Device: RF-CWC

Study type: Interventional

Funder types: Other

Identifiers

NCT07317089

GIRB-23614-PM

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 38 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Treatment arm A

Experimental group

Description:

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:

Device: RF-CWC