Androgenic alopecia
Conditions
Interventions
Test Group:Inject the test group product into a specific area of the subject's scalp
Control Group:The subject's scalp did not receive any treatment
Sponsors
West China Stomatological Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.18< = age< = 60 years, gender is not limited; 2. Clinically diagnosed androgenetic alopecia, all subjects showed localized alopecia; 3. The degree of hair loss conforms to Hamilton-Norwood classification III vertex, IV and V typing and/or Sinclair classification II-IV; 4. Accept to maintain the same hair length, hair color, and hairstyle for the duration of the study; 5. Subjects voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to collagen; 2. Pregnant or lactating women, or those who plan to become pregnant during the study; 3. Congenital or acquired permanent baldness; 4. Those who are prone to scars or hypertrophic scars; 5. Psoriasis, vitiligo, lupus erythematosus, folliculitis, acute inflammation, infection, trauma, etc. on the scalp at the treatment site; 6. Severe systemic diseases within 6 months prior to screening, such as: systemic infection, acute myocardial infarction or unstable angina, stroke, malignant tumors, and severe mental illnesses; 7. Those who have a known bleeding disorder, active bleeding or known bleeding tendency (international normalized ratio INR> 3.0 or platelet count <50×10^9/L), or use or plan to use anticoagulant drugs (such as heparin, coumarin derivatives, etc.) or antiplatelet drugs (such as aspirin, clopidogrel, etc.) within 1 month before screening or plan to use during the pilot study; 8. Those who have used systemic hormone therapy or topical hormone therapy at the treatment site within 3 months before screening, or have diseases that may affect wound healing, such as connective tissue disease, severe malnutrition, etc.; 9. Use or planned use of immunosuppressants (including small molecule immunosuppressants, etc.) within 3 months before screening; 10. Those who have received hair transplantation or plan to transplant hair during the trial; 11. Those whose hair has been permed and dyed within 3 months before screening, or who plan to be permed during the trial; 12. Shampoo or related products containing selenium sulfide, ketoconazole or other similar ingredients that may interfere with the efficacy evaluation within 3 months prior to screening or planned to be used during the trial; 13. Received or planned to receive hair loss medication (oral or topical minoxidil, finasteride, spironolactone, etc.), local injection of autologous platelet-rich plasma, low-intensity laser therapy, etc. within 6 months prior to screening; 14. Those who are "positive" for any one or more of the test results of hepatitis B surface antigen, hepatitis C ribonucleic acid or hepatitis C antibody, syphilis antibody and AIDS antibody; 15. Subjects with poor compliance as judged by the investigator; 16. Those who have participated in other medical device clinical trials or drug clinical trials within 3 months before the screening period (except for non-interventional studies); 17. Other situations in which the investigator believes that the investigator should not participate in this clinical trial for the benefit of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90 days after the last treatment in the test group and 135 days after randomization in the control group, changes in hair density detected by dermatoscopy compared to baseline were observed; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the hair density of one point in the scalp hair loss area detected by the independent investigator using a dermatoscopy, and compare the changes;Reduction of hair loss symptoms detected by dermatoscopy during follow-up; | — |
Countries
China
Contacts
Public ContactHang Wang
West China Stomatological Hospital of Sichuan University
Outcome results
None listed