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Study aim
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Evaluation of the efficacy of Minoxidil with Spironolactone in
comparison with Finasteride in the
treatment of female pattern and male pattern hair loss
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Design
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A clinical trial with two intervention groups, parallel, randomized, phase 3 on 60 patients, randomized with lottery
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Settings and conduct
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the study is performed in Firouzgar hospital, Tehran. Patients in the first group use minoxidil solution 2% once a day and spironolactone (100 mg daily in two doses) and patients in the second group use minoxidil solution 2% once a day and finasteride (5 mg per day), 4 months in both groups. For evaluation, at the time of beginning of treatment, 2 and 4 months later, the severity of alopecia is determined by the treating physician based on the Ludwig grade. Another physician, who does not know which group the patient is in, scores the improvement based on clinical imaging as well as dermatoscopic images. The patient's satisfaction with the treatment is also determined. Finally, the statistician analyzes the results of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: scalp involvement, aged 15-45 years, satisfaction to participate in the study, ability to follow the patient, normal hormonal tests.
Exclusion criteria: having an underlying disease, history of polycystic ovary syndrome, history of treatment in the last two months for the disease, contraindications to the use of spironolactone or finasteride such as pregnancy and lactation, concomitant use of drugs that may interact with the study drugs.
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Intervention groups
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Group 1: a combination of Minoxidil and Spironolactone.
Group 2: a combination of Minoxidil and Finasteride.
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Main outcome variables
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The severity of androgenetic alopecia based on Ludwig grade, qualitative and quantitative severity of androgenic alopecia based on clinical and dermatoscopic images