None listed
Conditions
Interventions
Drug : ? Divide the subject'
s face from left side to right side and inject the botulinum toxin intradermally (1 unit / 0.05 cc) at 1 cm intervals on the cheek area from the lower eyelid to the tail of the mouth on one side
* Sin
discomfort and adverse reactions at Visit 2 (Week 2), 3 (Week 4), 4 (Week 8), and 5 (Week 12).
? At the time of Visit 1 (week 0), pregnancy tests are performed with blood or urine for women of childbe
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adult men and women in their 30s and 50s 2) Those who can follow up during the clinical trial schedule (12 weeks) 3) Those who have no serious abnormalities in pre-examination or examination 4) A person who understands the consent before conducting all test-related evaluation / procedures, discloses the intention to participate in the clinical trial through himself or a legal representative, and signs the consent. 5) Those who can and willing to comply with the schedule of visits and other clinical trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1) Those with systemic neuromuscular junction disorder (Example: myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.) 2) Those who have the following treatment skills or who have plans during the clinical trial period that are thought to influence the evaluation of this clinical trial before the screening visit. -Those who have undergone a permanent filler (silicone, fat grafting, tissue grafting, etc.) procedure that may affect wrinkle evaluation -Those who have undergone a semi-permanent filler (CaHA (Calcium Hydroxyapatite), collagen-stimulator, etc.) procedure within 1 year prior to participation in clinical research -Those who have undergone temporary filler (hyaluronic acid, etc.) treatment within 6 months of participation in clinical research -Those who have undergone cosmetic procedures (radio-frequency treatment, HIFU, fractional laser, thread, chemical peeling over medium depth, etc.) on the face within 6 months of participation in clinical research -In the case of using cosmetics, external preparations, or oral drugs with wrinkle improvement function, there has been a change in use from 1 month prior to the screening time, or is expected to change during the clinical trial participation period even if they are used stably. 3) People with facial asymmetry, skin relaxation, or deep scars on the face that interfere with wrinkles and texture evaluation, or those with excessively thick skin 4) Those who are allergic to a drug for clinical trials or its components or have a history of hypersensitivity reactions 5) Those who received botulinum toxin treatment within 3 months prior to the administration of the drug for clinical trials, or who intend to receive botulinum toxin treatment other than the clinical trial drug during the clinical trial period 6) Subjects who are prone to bleeding or who have taken anticoagulant drugs within 7 days prior to administration of the drug for clinical trials or who cannot stop the anticoagulant medication during the clinical trial period 7) People with skin abnormalities or infections at the site to be scanned 8) Those who have a history of drug and alcohol abuse and mental illness 9) Women who are pregnant, lactating, or whose pregnancy has been confirmed through pregnancy tests, or who do not agree to contraceptive through the methods allowed in this clinical trial during the period of participation in the clinical trial. * All women of childbearing potential, except for women who have undergone amenorrhea or surgical infertility (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) for at least 12 months, have a negative pregnancy test (urine) result prior to the start of the trial / control drug. Only if you can participate in a clinical trial. Medically acceptable methods of contraception include spermicide, oral contraceptives, intrauterine implants, and complete abstinence. 10) Participating in other clinical trials at the time of screening or participating in another clinical trial within 30 days of screening. 11) People who are taking drugs that interact with botulinum toxins 12) Those who cannot communicate or are unable to follow directions 13) Patients who are not suitable for this clinical trial at the discretion of other investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between coretox injection site and physiological saline injection site ANTHERA® pores, wrinkles, and skin texture index | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in measurement of sebum secretion of visit 2, 3, 4, and 5 compared to visit 1, respectively, of coretox injection site and physiological saline injection site | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Je Kim
Samsung Medical Center
Outcome results
None listed