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

Phase 2

Completed

• Conditions: Female pattern hair loss (severity; Ludwig scale 1-2 ); female pattern hair loss; alopecia; alopecia in women; androgenetic Alopecia

• Registration Number: TCTR20220613005
• Lead Sponsor: Srinakharinwirot university

Brief Summary

Spironolactone is an alternative for female pattern hair loss in reproductive-age women when standard treatments fail. Taking 100 mg daily with 3% Minoxidil tends to be more effective than Minoxidil alone, but may cause mild menstrual irregularities. - Taking 100 mg of Spironolactone daily with Minoxidil enhances female pattern hair loss treatment efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-13
• Study Completion: 2023-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 43

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hair density 6 months videodermoscope

Secondary Outcome Measures

Name	Time	Method
hair diameter, hair density change, patient satisfaction 6 month videodermoscope, 7-point rating scale, 10 point visual analog scale