A study on the efficacy and safety evaluation of autologous skin fibroblasts for patients with depressed scar accompanied from healing process of acne
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0005616
- Lead Sponsor
- S.Biomedics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects improved by 2 or more levels by 7-level standardized photoguide method
- Secondary Outcome Measures
Name Time Method Physical Examinations;Laboratory Tests;Vital Signs;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