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OpenTrials
Completed

NCT Number: NCT07317089

Facial Contouring With Monopolar RF and Continuous Water Cooling

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.

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Key information

Age range

38 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Global Medical Evaluation Academy

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Jawline lifting

    Time frame: 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.

  2. Facial volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Innovative Facial Contouring Using a Monopolar Radiofrequency Device With Continuous Water Cooling: An Integrated Clinical and Preclinical Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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