Hypertrophic scarring
Conditions
Interventions
S1 experimental group:The study drug is dissolved in sodium chloride injection, and the study drug concentration is 300 U/mL, with an average of 0.2 mL per square centimeter of scar.
S2 experimental group:The study drug is dissolved in sodium chloride injection, and the study drug concentration is 600 U/mL, with an average of 0.2 mL per square centimeter of scar.
S3 experimental group:The study drug is dissolved in sodium chloride injection, and the study drug concentration is 1200 U/mL, with an average of 0.2 mL per square centimeter of scar.
Sponsors
Chen Junjie Medical Group, Department of Aesthetic Plastic Surgery/Burns, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18~75 years old (including the critical value). 2. Confirmed to meet the morphological characteristics of hypertrophic scars, in line with the diagnostic criteria for hypertrophic scars: its significant features are that the scar protrudes from normal skin tissue, the scar is confined to the range of skin lesions, and the subject reports that there is no significant scar regression in the near future. 3. Hypertrophic scars must meet one of the following two conditions: (1) The scar is continuous with the length >= 60 mm and the width >= 5 mm, and the investigator judges that one part of it can be selected as the treatment area, and the other part of the scar with comparable properties can be used as the control area; (2) The scar length of the selected treatment area and the control area was equal to or more than 30 mm, and the width was equal to or more than 10 mm, and the cause of the two scars was consistent as assessed by the investigator, and the formation time and scar nature were comparable. 4. Female subjects of childbearing potential must have a negative pregnancy test at the screening period and use highly effective contraception for 3 months after the screening period to the last dose; Male subjects whose partner is a female of childbearing potential are required to use highly effective contraception from the first dose to the last dose of study drug. 5. Subject is able to understand the steps of this study, is willing to comply with the clinical study protocol to complete this study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Known or suspected allergy to any component of the investigational drug, lidocaine and other drugs. 2. Keloids, atrophic scars or keloid carcinoma, with scar hyperplasia beyond the original injured area and tumor-like growth. 3. The scar is located on the head, face, and neck. 4. Subjects with conditions that are not suitable for treatment in the treatment area, such as infection, blood flow disorders, history of delayed healing, decreased soft tissue viability, active ulcers, etc., or neuromuscular diseases that may affect the evaluation of scar symptoms such as pain, numbness and other symptoms. 5. (Inquiry) Combined with serious internal diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.). 6. (Inquiry) Patients with coagulation dysfunction diseases such as idiopathic thrombocytopenic purpura or bleeding disorders. 7. (Interrogation) Patients with a history of mental illness, alcoholics. 8. Clinically significant abnormal laboratory test values (alanine aminotransferase and/or aspartate aminotransferase > 3.0 x ULN, creatinine >3.0 x ULN, prothrombin time >1.5 x ULN). 9. History of cosmetic treatment in the area to be treated, including: surgical excision, isotope application, local botulinum toxin injection within 6 months prior to screening; Laser treatment within 3 months prior to screening; Other treatments such as local fluorouracil injection, collagenase intra-scar injection, glucocorticoid intra-scar injection within 1 month prior to screening. 10. Those who are taking anticoagulant drugs. 11. Those who have taken tretinoin within half a year. 12. It is expected that the prohibited medications/treatments specified in the protocol will be used during the screening and treatment periods. 13. Subjects who have participated in another clinical study of a chemical or traditional Chinese medicine (administered within the past 30 days or 5 half-lives, whichever is longer) or a biologics (monoclonal or polyclonal antibody) (within the past 4 months or 5 half-lives, whichever is longer) prior to screening. 14. Subjects who plan to participate in another clinical study during the study period. 15. Pregnant or lactating female subjects. 16. The investigator judges that the subject is not able to follow the study process, or the investigator judges that it is not suitable to participate in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of POSAS scores at week 1, week 2, week 4, week 8, week 12, and week 16 after the first treatment compared with baseline;Changes of VSS scores at week 1, week 2, week 4, week 8, week 12, and week 16 after the first treatment compared with baseline;Comparison of the differences of POSAS changes from baseline between treated and untreated areas after 1, 2, 4, 8, 12, and 16 weeks of initial treatment;Comparison of the differences of VSS changes from baseline between treated and untreated areas after 1, 2, 4, 8, 12, and 16 weeks of initial treatment; | — |
Countries
China
Contacts
Public ContactChen Junjie
West China Hospital of Sichuan University
Outcome results
None listed