None listed
Conditions
Interventions
Medical Device : The face is divided bilaterally vertically, and the test device is applied to the clown area of ??one side, the anterior part of the ball, and the clown area by random assignment, and
Sponsors
Across
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man and woman aged 35 to 65 2) The volume of the frontal middle part or the cadaver area of ??both sides, the frontal part of the ball, and the lower part of the clown was 3 points (moderate) or more on both sides symmetrically as a result of independent field evaluator's MFVDS evaluation 3) Those who agreed not to receive filler, botulinum toxin, laser treatment, chemical peeling, or cosmetic surgery in the middle of the face during the clinical trial. 4) After thoroughly listening to the detailed explanation of the clinical trial, it is decided to participate voluntarily and agree with the written consent of the subject.
Exclusion criteria
Exclusion criteria: 1) Those who have taken the drug within 10 days from the date of application of the clinical test medical device or who are scheduled to take the following drug within 3 days after the application (but it is possible to apply the medical device for clinical test after 10 days of in vitro release); (Up to 300 mg / day dose is acceptable for low dose aspirin (less than 100 mg / Tablet)) and blood clotting time is delayed (eg, oral anticoagulants, anticoagulants, antiplatelet agents, Ingredients (Vitamin E, Garlic, Ginkgo biloba, etc.) 2) Before the screening, cosmetic surgery (except for upper eyelid surgery and postoperative 24-month nose surgery or lower eyelid correction) for facial cosmetic purposes or tissue grafting or tissue enlargement of silicone, fat, permanent or semi-permanent filler Or who is scheduled to be administered during the clinical trial 3) Those who have undergone facial procedures under the edge of orbit within 6 months from the screening date 4) Hyaluronic acid filler in the facial area within 12 months from the screening date, or donor collagen filler within 24 months or scheduled to be performed during the clinical trial5) Within 6 months from the screening date, a person who has undergone neuromodulator injections or mesotherapy, skin regeneration (laser, wave length, high frequency, mechanical or chemical peeling) 6) Those who received calcium hydroxyapatite (CaHA) treatment within 12 months from the screening date 7) Within 3 months from the screening date Oral or topical medicines, medicines or cosmetics (alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) Who will take / use 8) Those who have a thin skin on the central part of the face and tend to accumulate body fluid on the lower eyelid or orbital floor pad 9) Patients with acute abdominal fat associated with immune-mediated diseases such as congenital defects, trauma or systemic lipodystrophy, 10) Those who had a scarring disease (chickenpox, malignant acne, etc.) within 12 months, or who had scars or marks on the medical device 11) Those with skin diseases (skin infections, eczema, psoriasis, injections, herpes, etc.) or wound infections affecting the clinical trial 12) Persons with impaired or suspected immunity, patients with autoimmune disease 13) Anaphylaxis or severe allergic (allergy) Those with a history of symptoms 14) Those with a history of hypertrophic scars or keloids 15) Persons who are sensitive to lidocaine or amide-based local anesthetics 16) Those who have clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that has a significant effect on the trial 17) Malignant tumor patients 18) Those who participated in other clinical trials within 30 days from the screening date 19) Contraceptive use of medically acceptable methods (condoms, contraceptive methods continued for at least 3 months, intrauterine contraceptive devices, etc., when using contraceptive or injectable contraceptives) Do not agree with 20) Pregnant or lactating women 21) Those who have clinical findings that are deemed inappropriate for this clinical trial,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall MFVDS improvement rate assessed by independent photographer at 24 weeks after application of the clinical trial medical device | — |
Secondary
| Measure | Time frame |
|---|---|
| 3) Overall MFVDS change as assessed by independent photograph evaluators at 4 weeks, 12 weeks, 24 weeks, 32 weeks, 40 weeks, 48 weeks after baseline medical device application;4, 12, 24, 32, 40, 48 weeks after baseline versus medical device for clinical trial Overall MFVDS change as assessed by independent field assessors;MFVDS improvement rate by site assessed by independent photograph evaluator at 4 weeks, 12 weeks, 24 weeks, 32 weeks, 40 weeks, and 48 weeks after application of clinical test medical device;MFVDS improvement rate by site assessed by independent field evaluator at 4 weeks, 12 weeks, 24 weeks, 32 weeks, 40 weeks, and 48 weeks after application of clinical test medical device;Changes in MFVDS by sites assessed by independent photograph evaluators at 4, 12, 24, 32, 40, and 48 weeks after baseline medical device application;Changes in MFVDS by sites assessed by independent field evaluators at 4, 12, 24, 32, 40, and 48 weeks after baseline medical device application;Overall GAIS improvement rate as assessed by independent field assessors at 4, 12, 24, 32, 40, and 48 weeks after the application of the clinical trial medical device;Overall GAIS improvement rates assessed by subjects at 4 weeks, 12 weeks, 24 weeks, 32 weeks, 40 weeks, and 48 weeks after the application of the clinical trial medical device;safety assessment;Overall MFVDS improvement rate as assessed by independent photograph evaluators at 4 weeks, 12 weeks, 32 weeks, 40 weeks, and 48 weeks after application of the clinical trial medical device;Overall MFVDS improvement rate as assessed by independent field assessors at 4 weeks, 12 weeks, 24 weeks, 32 weeks, 40 weeks, 48 weeks after the application of the clinical trial medical device | — |
Countries
Korea, Republic of
Contacts
Public ContactBeomjoon Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed