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제목
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RF Aesthetic Medical Device Trial
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간략설명
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Applicants who are concerned about skin wrinkles and facial sagging
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모집기간
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~2025.08.22
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시험대상
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Foreign applicants aged 35 - 65
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 - Study Purpose
: To
evaluate the efficacy and safety of the RF in improving facial skin laxity and wrinkles
- What is RF?
: This RF (Radio Frequency) lifting
treatment utilizes dual high-frequency waves. It delivers high-frequency energy
deep into the dermis and subcutaneous fat layers, stimulating collagen
production and tightening the skin.
It is relatively less painful than other
treatments (a slight burning sensation may be present) and is effective in
reducing fine wrinkles and improving elasticity.
- Inclusion Criteria
1) Foreign applicants aged 35 - 65, including White/Hispanic (The date of signing the informed consent shall prevail), gender is not limited.
2) Facial and periorbital wrinkle and elasticity Scale
(FWES) Score = 3 points. Both the facial and periorbital FWES should meet the
criteria. (Those with visible crow's feet and facial sagging when in a relaxed ________expression)________
3) The subject fully understands the benefits and
risks of this experiment and is still willing to participate and sign the
informed consent.
- Exclusion Criteria
1) Individuals
with skin diseases, scars, open wounds, or metal implants in the area where
clinical trial medical devices will be applied.
2) Subjects
with implanted electrical devices (e.g., pacemakers, AICDs).
3) Those with
a history of hypertrophic scars, keloids, or severe allergic reactions. 4) Individuals
with excessive facial fat requiring surgical treatment.
5) Those with
autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
6) People with
abnormal coagulation function or those taking anticoagulant medications (e.g.,
aspirin, warfarin) within 1 week of screening.
7) Individuals
treated with fillers or botulinum toxin within the last 6 months or permanent
fillers in the treatment area.
8) Those who
have received skin treatments (e.g., deep exfoliation, lasers, light therapy)
in the treatment area within 6 months.
9) Pregnant or
lactating women, or women of childbearing potential not using medically accepted
contraception.
10) People
deemed inappropriate by the investigator to participate in this clinical trial.
Visiting Schedule
1st visit: One day between 2025/08/25 and 2025/08/29 2nd visit: One day between 2025/09/02 and 2025/09/05 3rd visit: One day between 2025/09/29 and 2025/10/02 4th visit: One day between 2025/10/27 and 2025/10/31 5th visit: One day between 2025/11/24 and 2025/11/28 -There will be a total of 5 visits. -At the second visit, you will need to move to the center for skin measurements after receiving skin treatment at the hospital. -Taxi fare(10,000 KRW)will be provided.
Participation fee: 500,000 KRW Recruitment incentive: 100,000 KRW - Address
[Center]
KBI Korea Biomediacal Research Institute, B-dong, 10F, room 1004, Central Biz Tower 2, 99
[Dermatologist's hospital]
OARO Dermatology
2F, room 223, 267, Sanseong-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
Inquiries about participation
'KBI 한국의생명연구원'
Please chat with us through KakaoTalk channel
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