androgenic alopecia
Conditions
Interventions
Test group:24 weeks. The Subjects will be instructed to administer the study drug on day 1. The subjects should apply 1g of 5% minoxidil foam to the bald area every morning and evening from the first
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Male, aged 18 to 55, in good general health. (2) The clinical diagnosis is androgenic alopecia, which met the AGA diagnostic criteria in the Chinese Androgenic Alopecia Diagnosis and Treatment Guidelines (2014 Edition), and the degree of alopecia met levels II, III and IV of the Hamilton-Norwood scale. (3) Subjects are willing to maintain the same hairstyle, hair length, and hair color throughout the study. (4) The subject is willing and able to comply with scheduled visits, treatment plans, and other trial procedures. (5) Subjects are willing to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) People who are known to be allergic to the test drug or known to be allergic to the ingredients of the study product. (2) Patients with other hair loss diseases. (3) Scalp skin disease that affects the efficacy evaluation, trauma to the target area of the scalp or other scalp skin lesions requiring topical drug treatment, such as fungal or bacterial infection, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy; Or combined with diseases that have an impact on hair growth, such as connective tissue disease, moderate and severe anemia in the short term weight loss. (4) Those who have a history of hair transplantation or need to wear wigs for a long time during experimental treatment. (5) Those who have used minoxidil or other topical drugs, or had received scalp radiation and/or laser or surgical therapy, or have taken androgen replacement therapy, immunosuppressants, corticosteroid preparations and other medications that may interfere with the evaluation of efficacy in the 3 months prior to screening. (6) Use medical shampoos or solutions containing ingredients such as ketoconazole or similar and other ingredients that may interfere with evaluation of efficacy within 1 month prior to screening. (7) History of malignant tumor. (8) Participating in or currently participating in an interventional drug or medical device clinical trial within 3 months prior to screening. (9) Those who have undergone major surgery within 3 months prior to screening, or planned to undergo major surgery during the trial. (10) The investigator believes that the subjects have other conditions that may affect compliance or are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Area Hair Count, TAHC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair growth assessment(HGA) ;Changes in average hair diameter in the target area;TAHC change rate;Change in the ratio of terminal hair to vellus hair in the target area; Changes in scalp physiological indexes;Physical and chemical properties of hair; | — |
Countries
Chinna
Contacts
Public ContactYang Dingquan
Dermatology Department of China-Japan Friendship Hospital
Outcome results
None listed