Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Participants of ages 19 and older
Those with at least 3 points (Moderate) of the IGA-LCL severity scale on both sides in the rest state during screening
Those who have visually symmetrical periorbital wrinkles on both sides and have the same IGA-LCL severity scale score in the rest state
Those who agreed to discontinue all dermatological treatments including facial wrinkle improvement during this study period
Subjects with healthy and undamaged skin at the sampling area (e.g., behind the ears, inside of the arms, armpits, groin, etc.)

Those who meet the following criteria based on the blood test at screening or baseline visits

White Blood Cell : ≥4.5x10^3/μl and ≤11.0x10^3/μl
Platelet count : ≥100x10^3/μl
Hemoglobin : ≥9 g/dL
Those who sign the written consent form after hearing the explanation of the purpose, method, and efficacy of this study
Those who can be followed up during the study period

Exclusion Criteria:

Those with arterial bleeding or severe variceal bleeding in the body
Those with hypersensitivity to bovine protein or gentamicin
Pregnant and breast-feeding or who planning to conceive within six months of clinical trial medication
Out of who are pregnant or breast-feeding and A woman who is likely to be pregnant in a postmenopausal or a state of non-Infertility surgery and men with reproductive abilities not willing or planning to use the appropriate contraception defined in this clinical trial during their participation in clinical trials
Those with or suspected of having autoimmune diseases (e.g., myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, etc.)
At the screening visit, patients with chronic skin disease or such a medical history
Those with a medical history or a positive test result for any of the following: hepatitis C virus antibody (HCV Ab), hepatitis B surface antigen (HBsAg), human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody (However, if HCV is proven to be completely cured based on the HCV RNA test, he/she can be enrolled as a subject.)
Those with severe heart diseases (e.g., myocardial infarction, heart failure, etc.) or severe liver diseases (e.g., hepatocirrhosis, liver failure, etc.) or severe kidney diseases (e.g., renal failure, etc.)
Those who have tumors or have such medical history within 5 years of screening (However, if the malignant tumor does not relapse for more than 5 years, the candidate may be enrolled as a subject, and in the case of basal cell carcinoma or intradermal squamous cell carcinoma that does not relapse after resection, he/she can be enrolled as a subject.)
Those with genetic diseases affecting fibroblast or collagen
Those who have undergone anticoagulant therapy or antiplatelet therapy within 10 days prior to administration of the study drug, or those who are expected to need to receive them within 3 days after administration of the study drug (However, if the drug is being administered at the time of screening, it is possible to participate in the clinical trial after a seven-day not administering medication period only if the temporary suspension does not pose a medical risk under the tester's judgment, tried tissue biopsy Schedule.)
Those who have active or infectious skin diseases (skin infection, inflammation, herpes, etc.), keloids, unhealed wounds or scars, tumors, etc. at the site where the study drug will be administered, or those who have previously received radiation treatment
Those with hypersensitivity to local anesthetics (however, those who agree to receive the procedure without applying an anesthetic agent due to hypersensitivity to local anesthetics, do not fall under this criteria.)
A person who has a history of significant adverse or hypersensitive reactions to the composition of medications for clinical trials
Those who have undergone procedures that can affect periorbital wrinkles, such as dermabrasion, skin regeneration, and plastic surgery, etc, among facial procedures including the eye area* or those who are expected to have such procedures during the study period
Those who participated in another study and received an investigational drug or used an investigational medical device within 6 months prior to participation in this study, or those who are scheduled to participate in another study during this study period
Those with a medical history of autologous dermal fibroblast treatment
Those with a medical history of anaphylaxis or severe complex allergies
Those with a medical history of keloid formation, hyperpigmentation, or hypertrophic scars on the face
Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, or central nervous system, or have had or currently have a mental disorder that significantly affects this study
Those who received systemic corticosteroid within 12 weeks prior to participation in this study
Those who refuse to take pictures of the site where the study drug is administered
Those who are judged to be ineligible by the investigator to participate in this study for other reasons