Effectiveness of Topical Minoxidil (5%) Plus Topical Finasteride (0.1%) Fixed-Dose Combination Versus Topical Minoxidil (5%) Plus Oral Finasteride (1 Mg/Day) in Grade II-IV Androgenetic Alopecia: A Randomized, Double Blind Clinical Trial

Abstract

Background: Male Androgenetic Alopecia is a common hair loss disorder that increases with age. The cornerstones of medical management are minoxidil and finasteride.No treatment is completely satisfactory.  Aims and Objectives: This study compared Topical Minoxidil 5%+Finasteride 0.1% combination (Group A) and Topical Minoxidil 5%+Oral Finasteride 1 mg/day (Group B) in treating Male Androgenetic Alopecia grade II-V by assessing efficacy and quality of life. Materials and Methods: In this double blind randomized, controlled trial, 72 patients were randomly allocated in 2 groups of 36 to receive either of the two treatments for six months. Patients received identically colored bottles of minoxidil 5% (Group B) or minoxidil 5%+finasteride 0.1% combination (Group A) and finasteride 1 mg tablets (Group B) or identical-looking placebo tablets (Group A).Changes in subject’s self-assessment and investigator’s assessment of hair growth, and patient’s and physician’s global assessment of disease activity improvement were recorded monthly. Symptoms and adverse effects were noted monthly. Clinical photographs were taken monthly. Hamilton-Norwood scale were recorded at baseline and end of treatment. Results: 32 patients in Group B and 30 in Group A completed treatment. Modified intention-to-treat analysis showed significant improvement in both groups from baseline to end of treatment. No significant difference was noted between two groups in any visit in subject’s self assessment, investigator’s assessment of hair growth, and patient’s and physician’s global assessment of disease activity improvement in any visit. Mild adverse effects were noted in 6.67% of Group A  and 9.37% of group B patients. Hamilton-Norwood Grade was improved in both groups and was comparable at the end of the treatment between both groups. Conclusion: Both the treatments are equally effective without too many remarkable side effects.