Androgenetic alopecia
Conditions
Interventions
Oral minoxidil group:Oral minoxidil ,5mg once daliy
Topical minoxidil group:Topical minoxidil foam ,twice daily
Sponsors
Eastern Theater Command of the Chinese People's Liberation Army.
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Informed Consent: The subjects fully understood the research content, voluntarily participated and signed a written informed consent form. 2. Age and Gender: Male, aged 18–50 years (inclusive). The upper age limit was set to exclude the interference of senile hair follicle atrophy and multiple cardiovascular underlying diseases. 3. Clinical Diagnosis: Confirmed by two senior dermatologists as Androgenetic Alopecia (AGA). 4. Hair Loss Grading: According to the Hamilton-Norwood grading scale, it is of type III-V. 5. Health Status: Physical examination, vital signs and laboratory tests showed no clinically significant abnormalities.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following conditions will be excluded: 1. Other types of hair loss: including alopecia areata, telogen effluvium (such as caused by recent surgery or high fever), scarring alopecia, trichotillomania, or secondary hair loss due to thyroid disorders, malnutrition, syphilis, etc. 2. Previous treatment history: 1) Within 6 months before enrollment, have used any form of minoxidil (oral or topical). 2) Within 6 months before enrollment, have used 5a-reductase inhibitors (finasteride, dutasteride). 3) Within 3 months before enrollment, have used anti-androgen drugs (such as spironolactone, cyproterone acetate), systemic glucocorticoids. 4) Have received hair transplantation surgery, scalp microneedling, platelet-rich plasma (PRP), or low-energy laser (LLLT) treatment before. 3. Cardiovascular risk: 1) Have a history of severe cardiovascular diseases, including but not limited to myocardial infarction, heart failure, angina pectoris, severe arrhythmia, pericardial disease. 2) Abnormal resting blood pressure during the screening period: systolic blood pressure 140 mmHg; diastolic blood pressure 90 mmHg. 3) Abnormal resting heart rate during the screening period: 100 beats/minute. 4) Electrocardiogram (ECG) shows clinically significant abnormalities (such as prolonged QT interval, pathological Q waves, conduction block, etc.). 4. Drug allergy and contraindications: allergic to minoxidil, finasteride, or excipients of the formulation (such as propylene glycol, ethanol). 5. Other systemic diseases: severe liver or kidney dysfunction (ALT/AST > 2 times the upper limit of normal, Cr > upper limit of normal), history of malignant tumors, history of mental illness. 6. Compliance: The investigator determines that the subject has poor compliance and is unable to take medication or follow up on time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Area Hair Count, TAHC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target area terminal hair density;Target Area Hair Diameter;Investigator Global Assessment;Safety Metrics;Patient Reported Outcomes; | — |
Countries
China
Contacts
Public ContactQingtao Kong
Eastern Theater Command of the Chinese People's Liberation Army.
Outcome results
None listed