None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Subjects are randomly assigned to either the test group or the placebo group according to the registered order.
The test drug or placebo is administered intraderm
Sponsors
S.Biomedics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants of ages 19 and older and younger than 60 2) Participants with acne scars of level 4 or higher in the standardized 7-level Photoguide index based on the investigator's assessment 3) Women of childbearing potential who have consented to clinically proven contraception 4) Participants with a depressed scar occurred during the treatment of acne and who have been diagnosed to have a medical treatment by a specialist 5) Participants with the following results in hematopoietic and coagulation functions: - White Blood Cell = 4.5×10^3/µL, = 11.0×10^3/µL - Platelet count = 100×10^3/µL - Hemoglobin = 9.0 g/dL 6) A participant who has consented in writing him/herself or through a legal representative.
Exclusion criteria
Exclusion criteria: 1) Pregnant and breast-feeding women 2) Individuals who are hypersensitive to bovine protein and gentamicin 3) Individuals who are HIV, HCV, and HBV antigen positive 4) Individuals who have participated in other clinical studies related to acne scars within the last 6 months 5) Individuals with a chronic skin disease or a local infection in the area of denatured epidermal tissue 6) Individuals with acute or chronic infectious diseases requiring medical treatment during the study period 7) Individuals with blood sugar levels above 300 mg/dl or who have uncontrolled diabetes 8) Patients with severe cardiac diseases (myocardial infarction, angina pectoris, arrhythmia, and congestive heart failure, etc.) 9) Patients with chronic kidney failure 10) Individuals with severe liver diseases (liver failure, acute or chronic hepatitis, and hepatocirrhosis, etc.) 11) Individuals with a history of hypersensitivity to drugs or other substances 12) Individuals with autoimmune diseases (lupous erythematosus, rheumatoid arthritis, and severe myasthenia gravis, etc.) 13) Patients with arterial bleeding and severe venous bleeding 14) Keloid patients 15) Patients with serious acnes 16) If corticosteroids are used in combination with or used alone (it is allowed if administered for treatment of acute hypersensitivity reactions or administered in low doses [Methyl prednisolone 20 mg or less or equivalents] from 6 months prior to administration of the investigational product) 17) Individuals with a previous drug exposure for autologous fibroblasts 18) Individuals who have taken medications for acne treatment within one year of enrollment 19) Individuals who have had plastic surgery or undergone procedures related to acne scars on the face within the last 4 weeks 20) Individuals who are considered unsuitable for clinical studies due to serious psychiatric illness 21) Other patients who are considered unsuitable to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects improved by 2 or more levels by 7-level standardized photoguide method | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ECCA grading scale scores;Improvement of 6-level depressive acne scars;Changes in the subject's satisfaction scores;Proportion of subjects improved by 1 levels by 7-level standardized photoguide method;Adverse Events;Physical Examinations;Laboratory Tests;Vital Signs | — |
Countries
Korea, Republic of
Contacts
Public ContactBeomjoon Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed