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Efficacy and safety of oral spironolactone combined with 3% topical minoxidil for the treatment of female pattern hair loss in premenopausal women

Efficacy and safety of oral spironolactone combined with 3% topical minoxidil for the treatment of female pattern hair loss in premenopausal women: A randomized, double- blind, placebo-controlled study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220613005
Enrollment
48
Registered
2022-06-13
Start date
2022-09-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female pattern hair loss (severity

Interventions

Spironolactone(100mg/day) combined with 3% topical minoxidil solution twice daily,Oral placebo combined with 3% topical minoxidil solution twice daily
Active Comparator Drug,Active Comparator Drug
Spironolactone combination with topical minoxidil,Placebo combination with topical minoxidil

Sponsors

Srinakharinwirot university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. The patient who is diagnosed with female pattern hair loss (Ludwig grade 1-2) 2. Premenopause 3. Ability to see a doctor by appointment 4. Agree to join in research and sign a consent form 5. Get COVID-19 vaccination at least 2 dose

Exclusion criteria

Exclusion criteria: 1. History of chronic renal disease, hepatic disease, cardiovascular disease, Hypertension, Diabetes Mellitus, cancer and Addison's disease. 2. Family history of breast cancer in first degree relatives. 3. Allergic to spironolactone or minoxidil. 4. The patients who take drugs that caused interaction with spironolactone, for example, ACE inhibitors, angiotensin II antagonists, heparin, low molecular weight heparin, lithium, NSAIDs, digoxin, chloestyramine, narcotic drug, corticosteroids. 5. During pregnancy or breast feeding periods. 6. The patients who don't get contraception. 7. The patients who has at least 1 abnormal serum level of BUN > 20.1 mg/dL, creatinine > 1.17, sodium < 135 mmol/L, potassium > 5.1 mmol/L 8. The patients who had history of using drugs that affect to hair regrowth within 6 months before participating in research study, for example, finasteride, dutasteride, flutamide, cyproterone acetate, spironolactone, minoxidil, cimetidine, diazoxide, cyclosporine, ketoconazole,corticosteroids, chemotherapeutic agents, anticonvulsant ,vasodilators 9. The patients who had history of using topical drugs that affect to hair regrowth within 3 months, for example, minoxidil ,finasteride. 10. The patients who had history of using shampoo or hair serum that affects to hair regrowth within 1 months 11. The patients who had history of other treatments for hair loss within 3 months before participating in research study, for example, low-level laser/light therapy ,platelet-rich plasma. 12. The patients who had history of hair transplantation before participating in research study. 13. The patients who has underlying diseases that can cause hair loss, for example, hypo/hyperthyroidism, anemia, malabsorbtion syndrome ,trichotillomania 14. History of diet control or abnormal eating disorder. 15. History of abnormal scalp disease such as seborrheic dermatitis, Tinea capitis

Design outcomes

Primary

MeasureTime frame
hair density 6 months videodermoscope

Secondary

MeasureTime frame
hair diameter, hair density change, patient satisfaction 6 month videodermoscope, 7-point rating scale, 10 point visual analog scale

Countries

Thailand

Contacts

Public ContactPimpakarn Werachattawatchai

Srinakharinwirot University

swuec@g.swu.ac.th026495000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026