androgenetic alopecia
Conditions
Interventions
Microneedle + Minoxidil group:All study participants were sprayed with 1 ml of Minoxidil 5% application each time on the scalp area starting on day 1, applied evenly to all scalp areas, and the scalp
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Male, aged 18-60 years; (2) Clinical diagnosis of androgenetic alopecia with receding frontal hairline and/or progressive reduction and thinning of hair on the top of the head; (3) No topical use of hair regrowth medication or systemic treatment for alopecia areata disease in the 3 months prior to enrolment; (4) Voluntary participation in the study and ability to provide a written ICF; (5) Able to follow the clinical protocol strictly and have good compliance with the subject study;
Exclusion criteria
Exclusion criteria: (1) Those who are known to suffer from hair loss diseases other than AGA, such as pemphigus or diffuse pemphigus, syphilitic alopecia, scarring alopecia, malnutrition, and alopecia due to chemotherapy/radiotherapy; (2) Those with scalp skin diseases that affect the evaluation of efficacy, trauma to the scalp or other scalp skin lesions requiring topical medication, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy; (3) History of cardiac, hepatic or renal insufficiency, hypertension, tumours, neurological or psychiatric disorders; (4) Those who have used topical medications that may interfere with the evaluation of efficacy for 2 consecutive weeks or more on the hair loss site (including corticosteroids, estrogens, Chinese herbal preparations, etc.) in the 3 months prior to screening; (5) Those who have taken androgen replacement therapy, immunosuppressants and other drug treatments that may interfere with the evaluation of efficacy within 3 months prior to screening; (6) Have used minoxidil within 6 months prior to screening; (7) Have received autologous platelet-rich plasma for AGA or have received chemotherapy or cytotoxic agents within 12 months prior to screening, and have received scalp radiation and/or treatment for AGA with low-energy laser or scalp surgical therapy within 12 months prior to screening; (8) Allergy to the test drug or known hypersensitivity to the components of this investigational product; (9) Individuals who have atrophied scalp follicles resulting in no hair regrowth; (10) Patients who plan to use any adjunctive or concomitant therapy for the treatment of hair loss during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TAHC, Target Area Hair Counts (The average change between 8 16 and 24 weeks of treatment and baseline); | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-vellus hair diameter (TAHW) in the target area (changes from baseline at 8 16 and 24 weeks of treatment);HGA, Hair growth assessment;Global Shooting Hair Changes;Scalp physiological indicators; | — |
Countries
China
Contacts
Public ContactWang Lei
China-Japan Friendship Hospital
Outcome results
None listed