Hypertrophic scars and keloids—collectively referred to as pathological scars—are fibroproliferative disorders of the skin that arise during the wound-healing phase following cutaneous injury and exhibit marked ethnic and racial variability. Both conditions represent aberrant fibroblast proliferation and extracellular matrix deposition within the reticular dermis, characterized by chronic dermal i
Conditions
Interventions
Low-dose group:The extracellular vesicle particle concentration of GD001 is 1×10? particles/mL. It is administered at a rate of 1 drop (approximately 50 µL) immediately after surgery, on the 1st day,
Low-dose group:The extracellular vesicle particle concentration of GD001 is 4×10? particles/mL. It is administered at a rate of 1 drop (approximately 50 µL) immediately after surgery, on the 1st day,
Research expansion stage:An additional 20 subjects will be enrolled and randomly assigned to either the trial group (GD001 group) or the control group (GD001 placebo group). GD001 extracellular vesicl
Sponsors
Plastic Surgery Hospital,Peking Union Medical College Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged >= 18 and <= 50 years. 2. Generally healthy aside from the presence of scars, as determined by medical history, vital signs, physical examination, and clinical laboratory tests, with no clinically significant abnormalities (i.e., normal or only mild deviations without clinical relevance). 3. Participants who meet the diagnostic criteria for pathological scars (hypertrophic scars or keloids). 4. Visible pathological scars located at any anatomical site except the face, caused by trauma or surgery, and patients who are scheduled to undergo surgical treatment of the scar. 5. Participants and their partners agree to use effective contraception throughout the study period (from screening until 3 months after completion of treatment). 6. Ability and willingness to provide written informed consent after full understanding of the study procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of active systemic or local infection, including but not limited to secondary infection of the scar, or bacterial, viral, or fungal infection at the target lesion site. Note: Participants may be rescreened after complete resolution of infection. 2. History of any of the following infectious diseases: hepatitis B, hepatitis C, HIV infection, or syphilis. 3. Receipt of live or attenuated vaccines within 4 weeks prior to screening or planned vaccination during the study period. 4. Allergen-specific immunotherapy within 6 months prior to screening. 5. Use of prohibited therapies within the specified timeframes prior to enrollment: Topical medications known or suspected to affect scar formation (e.g., topical corticosteroids) within 2 weeks prior to screening; Intralesional corticosteroid injections for scars within 4 weeks prior to screening; Systemic or local traditional Chinese medicine (including herbal soaking treatments) within 2 weeks prior to screening; Laser therapy or similar interventions within 4 weeks prior to screening; Systemic anti-inflammatory or anti-allergic treatments within 4 weeks prior to screening. 6. History of any significant clinical disease other than scars, or clinically meaningful abnormalities involving the cardiovascular, endocrine, neurological, hematologic, immune, psychiatric, or unstable metabolic disorders. 7. History of severe dermatologic allergies and/or known hypersensitivity to any component of the investigational product. 8. Receipt of any treatment that may affect wound healing, tissue growth, hemostasis, or coagulation within 30 days prior to randomization. 9. Participants with bleeding disorders or coagulation abnormalities. 10. Pregnant or breastfeeding women, or women planning to become pregnant during the study period (women of childbearing potential must have a negative urine pregnancy test at screening). 11. Participation in another clinical trial currently or within 30 days prior to screening. 12. Any other condition that, in the investigator’s judgment, makes the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical monitoring of adverse events and serious adverse events;The incidence of abnormalities in blood routine, blood biochemistry, urine routine, physical examination, etc; | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores of the Scar Assessment Scale (POSAS) of patients and observers at 3 and 6 months after the first treatment were compared with those on the control side and at baseline;The scores of the Vancouver Scar Scale (VSS) at 3 and 6 months after the first treatment were compared with those on the control side and at baseline;The recurrence rate at 6 months after the first treatment was compared with that on the control side and at baseline;Skin Inflammation Severity Assessment Scale: The normal and abnormal changes of each dose group before and after medication are compared through the clinical judgment cross-scale before and after medication; | — |
Countries
China
Contacts
Public ContactZang Mengqing
Plastic Surgery Hospital,Peking Union Medical College Chinese Academy of Medical Sciences
Outcome results
None listed