Male androgenetic alopecia
Conditions
Interventions
Group A (twice a day of study drug, once of placebo):3 times daily, 1 tablet each time, given continuously for 24 weeks
Group B (three times a day of study drug):3 times daily, 1 tablet each time, given continuously for 24 weeks
Sponsors
The Affiliated Guangdong Second Provincial General Hospital of Jinan University
Eligibility
Sex/Gender
Male
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Male, 18 years <= age <= 49 years; 2. Clinically diagnosed with AGA (Androgenetic Alopecia); 3. Severity of AGA classified as Hamilton-Norwood grade IIIv, IV, or V; 4. Willing to use the same shampoo and hair care routine throughout the study; 5. Willing to comply with the study protocol, including microdot tattooing on the target scalp area (1cm × 1cm on the top of the head); 6. Voluntarily enrolled and signed the informed consent form in writing; 7. The subject agrees to use appropriate medical contraception from the time of signing the informed consent form until three months after the last dose to prevent pregnancy of sexual partners.
Exclusion criteria
Exclusion criteria: 1. Have used before screening: (1)Use of 5-a-reductase inhibitors: finasteride, dutasteride within 2 weeks; (2) Systematic use of corticosteroids or synthetic steroids within 2 weeks; (3) Use of antiandrogen drugs within 2 weeks: flutamide, cyproterone acetate, drospirenone, estrogen, progesterone, cimetidine, spironolactone, or ketoconazole; (4) Minoxidil (including topical or oral) used within 4 weeks; (5) Have used drug-containing shampoos or conditioners (drug-containing shampoos and conditioners refer to any prescription shampoos or conditioners, as well as any over-the-counter drug-containing shampoos or conditioners, such as Fengtian, Bawang, Fuludeya, Head & Shoulders Scalp X shampoo, etc.), or other daily necessities that affect hair growth. (6) Use of ß receptor blockers within 6 months: propranolol, atenolol, metoprolol, etc.; (7) Received chemotherapy, cytotoxic drugs, local injection of autologous platelet-rich plasma (PRP) and other microneedling, external therapy, scalp radiotherapy and/or laser/surgical treatment within 12 months; 2. Subjects who are known to be allergic to minoxidil or allergic to the ingredients or mimics of this study product, or to any component of tattoo liquid; 3. Uncontrolled hypertension (blood pressure is still higher than 140mmHg/90mmHg with two antihypertensive drugs), or history of hypotension (blood pressure is lower than 90mmHg/60mmHg); 4. The results of vital signs, electrocardiogram, blood routine, urine routine, and blood biochemistry test during the screening period are abnormal and clinically significant, and affect the safety assessment of the subject as judged by the investigator; 5. Positive for human immunodeficiency virus (HIV) and Treponema pallidum antibody; 6. Combined with other hair or scalp diseases in addition to AGA, such as diffuse telogen effluvium, alopecia areata, scarring alopecia, syphilis alopecia, hair loss caused by malnutrition, trichotillomania, etc.; 7. At the time of screening, the investigator judged that the subject has scalp skin abnormalities or scalp skin diseases that may interfere with the purpose and evaluation of the study, and the scalp has trauma or other scalp skin lesions that require topical drug treatment, such as fungal or bacterial infections, psoriasis, eczema, scarring, scalp trauma or scalp atrophy, contact dermatitis, severe folliculitis, severe seborrheic dermatitis; 8. The investigator believes that the subject has diseases that may affect the purpose and evaluation of the study, such as: current clinical hyperthyroidism or clinical hypothyroidism, inflammatory bowel disease, heart disease, polycystic ovary syndrome under intervention, etc.; 9. Those who plan to undergo hair transplantation before screening and during the trial, or who need to wear a wig headgear and hair bonding for a long time during the trial treatment; 10. Participating in or planning to participate in other interventional clinical studies during the trial; 11.There are other conditions that the investigator believes are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the change in non-vellus hair count (TAHC) in the target area (vertex 1cm×1cm) after 24 weeks of treatment compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the changes in TAHC in the target area from the baseline at 8 weeks, 12 weeks, and 16 weeks of treatment;Evaluate the changes in the Hamiltonian Norwood classification from baseline at 8 weeks, 12 weeks, 16 weeks, and 24 weeks of treatment.;Evaluate the changes in the full-head hair photography scores of the researchers in a blind state at 8 weeks, 12 weeks, 16 weeks, and 24 weeks of treatment compared to the baseline.;The scores of the subjects on the hair growth Index (HGI) were evaluated at 8 weeks, 12 weeks, 16 weeks and 24 weeks of treatment.;Evaluate the treatment satisfaction of patients with minoxidil sustained-release tablets.;Evaluate the occurrence of adverse events during the study period, including the incidence rate, specific events, and severity; | — |
Countries
China
Contacts
Public ContactJu Wen
The Affiliated Guangdong Second Provincial General Hospital of Jinan University
Outcome results
None listed