Androgenetic alopecia
Conditions
Interventions
Method A group:Eligible subjects will be randomly assigned in a 1:1 ratio to Arm A (intradermal injection group) or Arm B (microneedle combined with topical application group). In symmetrical areas of
Method B group:Subjects who meet the inclusion criteria will be randomly assigned in a 1:1 ratio to Arm A (intradermal injection group) or Arm B (microneedling combined with topical application group)
subsequently, according to the side determined by randomization, one side of the scalp will be topically treated with the i-PRF preparation, and the other side will be topically treated with an equal
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Agree to follow the trial treatment protocol and visit schedule, voluntarily enroll, and sign the written informed consent; 2. Male, aged 18 to 55 years, in generally good health; 3. Clinically diagnosed with androgenetic alopecia. The diagnosis meets the AGA diagnostic criteria outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia (2023 Edition)", with hair loss severity corresponding to Hamilton-Norwood scale III vertex, IV, or V (Figure 1); 4. Willing to maintain the same hairstyle, hair color, and hair length at each follow-up visit; 5. Disease duration >=6 months, and has not received any AGA-related treatment (including oral medication, topical preparations, physical therapy, etc.) in the past 3 months; 6. Willing and able to comply with the scheduled visits, treatment plans, and other trial procedures.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria are not eligible for inclusion: 1. Having other types of hair loss disorders (such as alopecia areata, scarring alopecia, telogen effluvium, etc.); 2. Presence of active scalp skin lesions (such as psoriasis, acute seborrheic dermatitis, folliculitis, etc.); 3. Blood system diseases or coagulation abnormalities; 4. Platelet count 450×10?/L; 5. Severe systemic diseases (such as uncontrolled diabetes, severe cardiovascular or cerebrovascular diseases, malignant tumors, etc.); 6. Use of anticoagulants or nonsteroidal anti-inflammatory drugs within 2 weeks prior to enrollment; 7. History of confirmed hypersensitivity to blood products; 8. Mental illness or cognitive impairment preventing cooperation with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair Density within the target area, HD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Hair Shaft Diameter, MHD;terminal anagen hair count, TAHC;terminal anagen hair width, TAHW;terminal/vellus ratio, T/V;hair growth assessment, HGA;Global Aesthetic Improvement Scale, GAIS;Hairdex Scale;Scalp Seborrheic Dermatitis, SSD;Scalp environment parameter detection;Likert Scale; | — |
Countries
China
Contacts
Public ContactLi Nuo
China-Japan Friendship Hospital
Outcome results
None listed