A randomized clinical trial on therapeutic effects of 0.25 mg oral minoxidil tablets on treatment of female pattern hair loss

Abstract

Topical minoxidil solution is recommended treatment for female pattern hair loss.However, some complications, such as skin allergies, have prevented some patients from completely receiving this treatment. This study intends to evaluate the therapeutic and side effects of oral minoxidil 0.25 mg tablets treatment on FPHL and compare it with conventional treatment of 2% topical minoxidil. This study is a tripleblind randomized clinical trial in which 72 women with FPHL were treated as two separate groups. Group 1 was treated with oral minoxidil 0.25 mg tablets and topical placebo solution, while topical minoxidil solutions and oral placebo tablets were used to treat group 2 patients. In the oral minoxidil group, the average hair diameter and hair density after the 9-month treatment reached from 0.044 mm and 102 per cm 2 to 0.048 mm and 115 per cm 2 , respectively. In the topical minoxidil group, the average hair diameter and hair density from initial values of 0.044 mm and 107 per cm 2 increased to 0.047 mm and 113 per cm 2 . In both groups, the changes of hair diameter and hair density were significant compared to initial values (p < 0.001), while the trend of changes was not statically different between the two groups (p = 0.077, p = 0.674 for hair diameter and hair density, respectively) and side effects were trivial. In conclusion, oral minoxidil is an effective and new treatment for FPHL, even with a minimal dose, which can be used as an alternative treatment, especially for patients with poor compliance against topical minoxidil.female pattern hair loss, oral minoxidil, topical minoxidil, trichoscopy | INTRODUCTIONFemale pattern hair loss (FPHL) is the most common form of hair loss in women. [1][2][3] It occurs in a generally distinctive pattern characterized by a progressive decline in fiber production by scalp hair follicles and their eventual miniaturization. 1 It can damage a patient's self-esteem and may even cause some psychological problems. 4 Therefore, achieving a simple treatment that can be readily acceptable for different patients is essential.

There Is a Positive Dose-Dependent Association between Low-Dose Oral Minoxidil and Its Efficacy for Androgenetic Alopecia: Findings from a Systematic Review with Meta-Regression Analyses

“…Figure 1 delineates our search process; we identified six studies that were eligible for quantitative analyses [ 11 , 12 , 13 , 14 , 15 , 16 ] (Fig. 1 ).…”

Low-Dose Oral Minoxidil for Alopecia: A Comprehensive Review

“…The safety and efficacy of oral minoxidil for treating FPHL have been evaluated in several studies [34,35]. These studies used minoxidil doses from 0.25 to 1.25 mg for duration of 6-12 months (Table 1) [2][3][4][5][6][7].…”

“…In a three-blinded, randomized pilot study, 6 female patients (per protocol analysis) received minoxidil 0.25 mg/day for 6 months [2]. Total hair density and hair diameter increased from 102 hair/ cm 2 to 112.2 hair/cm 2 and 0.043-0.045 μm, respectively (Table 1).…”

“…Hypertrichosis and CVS symptoms are the two predominant side effects of LDOM when used to treat alopecia. CVS symptoms refer to a group of side effects that include hypotension, edema, premature ventricular contractions, fatigue, tachycardia, and ECG changes [2–6, 9, 10]. Very few patients have been reported to develop type B idiosyncratic reactions: pericardial effusion and generalized anasarca [40–44].…”

“…While topical minoxidil has FDA approval for treating both male androgenetic alopecia (AGA) and femalepattern hair loss (FPHL), the use of oral minoxidil is off-label [1]. However, several studies report that low-dose oral minoxidil (LDOM), with a daily dose ranging from 0.25 to 5 mg, has a favorable safety and efficacy profile for treating both male AGA and FPHL [2][3][4][5][6][7]. Moreover, oral minoxidil has shown some efficacy in other types of alopecia, including chronic telogen effluvium, alopecia areata, anagen effluvium, loose anagen syndrome, monilethrix, lichen planopilaris, etc.…”