female pattern hair loss
Conditions
Interventions
High dose group:Spironolactone 40 mg tid x 24 weeks
2 spironolactone tablets 3 times a day for all trial periods (24 weeks treatment)
low dose group:Spironolactone 20mg tid x 24 weeks
1 spironolactone tablet + 1 spironolactone simulant 3 times per day for all trial periods (24 weeks of treatment).
placebo-controlled group:Spironolactone simulant x 24 weeks
2 spironolactone simulants 3 times per day for all trial periods (24 weeks of treatment).
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Women aged 18-60 years old; 2) A clear diagnosis of female pattern hair loss (Refer to the 2022 version of the Chinese Expert Consensus on the Diagnosis and Treatment of Androgenic Hair Loss in Women) 3) meet the Savins score for female pattern hair loss I-3 and above 4) have no plans to have children during the study period and for 3 months after the last dose and are able to use highly effective contraception. 5) Agree to follow the trial treatment protocol and visit schedule, enroll voluntarily, and sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1) FPHL patients with a predominantly "Hamiltonian" pattern (bilateral frontal-temporal angular recession, which may be accompanied by apical thinning, similar to male androgenetic alopecia); 2) History of diagnosed hypotension (blood pressure <90 mmHg/60 mmHg) 1 month prior to screening; 3) Pregnant and lactating females; females of childbearing potential with a positive serum pregnancy test within = 7 days prior to the first dose of test drug; 4) Abnormal and clinically significant results on physical examination, vital signs, 12-lead electrocardiogram, routine blood, urine, and blood biochemistry tests during the Screening Period that, in the judgement of the Investigator, affect the assessment of the efficacy and safety of the subject and the outcome of the trial; 5) Have a history of serious clinical systemic disease/surgery of any uncontrolled condition that may affect the evaluation of the safety and efficacy of the test drug, such as circulatory, neurological, haematological, gastrointestinal (e.g., inflammatory bowel disease), immune, and psychiatric system disorders; 6) Those who are known to suffer from hair loss diseases other than female pattern alopecia, e.g., pemphigus or diffuse pemphigus, syphilitic alopecia, scarring alopecia, malnutrition, alopecia due to chemotherapy/radiotherapy; 7) 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; 8) Those with a combination of diseases that have an impact on hair growth, e.g. connective tissue disease, inflammatory bowel disease, moderate to severe anaemia, significant weight loss in a short period of time; 9) persons with the following diseases: tumours of the androgen-secreting adrenal glands or ovaries, Cushing's syndrome, congenital adrenal hyperplasia 10) those with a history of hair transplantation, who need to wear wig headgear and hair bonding for a long period of time during the experimental treatment; 11) Those who have used topical medications that may interfere with the evaluation of efficacy (including corticosteroids, estrogens, etc.) topically on the hair loss site for 2 or more consecutive weeks during the 3 months prior to Screening; 12) concurrently receiving medications/treatments known to cause hair loss (e.g. isotretinoin, chemotherapy/cytotoxic agents, head radiotherapy, etc.); 13) Current use of any of the following; potassium-sparing diuretics; angiotensin-converting enzyme inhibitors; angiotensin receptor blockers; digoxin; 14) Have taken androgen replacement therapy, immunosuppressive drugs, or other medications that may interfere with the evaluation of the efficacy of the treatment within 3 months prior to screening; 15) Minoxidil has been administered orally or topically within 3 months prior to Screening; 16) treatment with spironolactone or cyproterone prior to Screening; 17) who have received autologous platelet rich plasma for FPHL within 6 months prior to screening; 18) who have received scalp radiation and/or treatment for FPHL with low energy laser or scalp surgical therapy within 6 months prior to screening; 19) Patients who plan to use any adjuvant or concomitant therapy for the treatment of alopecia areata during the study period; 20) History of malignancy within 5 years prior to screening; 21) those w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Target Area Hair Counts (TAHC) from baseline to week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Target Area Hair Counts (TAHC) from baseline to week 12;Changes in diameter of non-cui hairs, ratio of terminal hairs/cui hairs, and density of hair follicles in the target area;Change in sinclair score at week 12 and 24 of treatment compared to baseline;Hair growth assessment, patients assessed hair growth after 12 and 24 weeks of treatment based on baseline photographs; | — |
Countries
China
Contacts
Public ContactWei Shi
Xiangya Hospital, Central South University
Outcome results
None listed