Androgenic alopecia
Conditions
Interventions
Control group:2% minoxidil tincture twice daily,Dosage of 1ml each time for 24 weeks
intervention group A:2% minoxidil tincture 1ml bid combined with microneedle q2w for 24weeks
intervention group B:2% minoxidil tincture 1ml bid combined with microneedle q4w for 24weeks
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Female, age 18-45; 2) The clinical diagnosis is androgenic alopecia; 3) The severity of alopecia was graded D3-D6 according to Savin; 4) Subjects are willing to maintain the same hair style, hair color, and hair length at each follow-up visit; 5) There was no parenting plan during the study period and within 3 months after the last dose, and highly effective contraception was available.
Exclusion criteria
Exclusion criteria: 1)Known hair loss disorders other than androgenic alopecia areata (AGA), such as alopecia areata or diffuse alopecia areata, alopecia sypetica, cicatricial alopecia, malnutrition, hair loss due to chemotherapy/radiotherapy; 2) Scalp skin diseases that affect the efficacy evaluation, scalp trauma 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; 3) Those who have a history of hair transplantation and need to wear wigs and hair adhesives for a long time during the trial treatment; 4) Topical drugs (including corticosteroids, estrogens, etc.) that may interfere with the evaluation of efficacy have been used locally for 2 weeks or more in the 3 months before screening. 5) Patients who had taken androgen replacement therapy, immunosuppressants and other drugs within 3 months prior to screening that may interfere with efficacy evaluation; 6) Used minoxidil within 6 months before screening; 7) Patients treated with spironolactone or cyproterone within 6 months before screening; 8) Received autologous platelet-rich plasma therapy AGA within 12 months before screening; 9) AGA has been treated with chemotherapy, cytotoxic agents, scalp radiation and/or low-energy laser or scalp surgical therapy within 12 months prior to screening; 10) Use of medical shampoos or solutions containing other ingredients such as ketoconazole or similar ingredients (eg. Terzolin) that may interfere with evaluation of efficacy within 1 month prior to screening; 11) Patients who plan to use any complementary or concomitant therapy to treat hair loss during the study period; 12) People who are allergic to minoxidil or intolerant to microneedles; 13) History of malignant tumor within 5 years before screening; 14) Have undergone major surgery within 3 months prior to screening, or plan to undergo major surgery during the trial; 15) Participants who have participated or are participating in clinical trials of interventional drugs or medical devices within 3 months prior to screening (except for non-interventional studies, and those who only signed ICF and did not receive research interventions); 16) Had a history of drug abuse within 1 year before screening, had used drugs or had a history of alcohol dependence within 3 months before the test; 17) 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 Counts; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of hair growth;Non-vellus hair diameter in the target area; Hair density in the target area;Cumulative diameter in the target area;Mental state assessment; | — |
Countries
China
Contacts
Public ContactYing Luo
Dermatology Hospital of Southern Medical University
Outcome results
None listed