• Clinical efficacy and safety of low-dose oral minoxidil versus topical solution in the improvement of androgenetic alopecia: A randomized controlled trial
  • Ali Asilian,1,* Aida Farmani,2 Mina saber ,3
    1. Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
    2. Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
    3. Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.


  • Introduction: Androgenetic alopecia (AGA) is the most common form of progressive hair loss with an increasing prevalence with age.1 The exact mechanisms underlying AGA susceptibility and initiation have not been entirely understood. It is believed AGA is a polygenic condition whose development and occurrence depend on the interaction of genetic, endocrine factors, and environment.2 Numerous studies have demonstrated that AGA severely affects patients' quality of life and self-esteem.3 On the other hand, AGA has remained a therapeutic challenge to dermatologists considering the fact that patients' expectation of therapeutic results is usually higher than reality.4 The current FDA-approved treatments for AGA include topical minoxidil 2%–5%, oral finasteride, and low-level light therapy.5 Among them, topical minoxidil solution is the most commonly prescribed medication.3, 6, 7 Although the precise mechanism of action of minoxidil is not well understood it seems it acts through multiple pathways including vasodilation, inflammation reduction, and the induction of the Wnt/β-catenin pathway.8 However, limited efficacy (up to 40% of patients),9 lack of compliance, allergic/irritant contact dermatitis, undesirable hair texture, and cost are common barriers to the application of topical minoxidil.10 Recently, oral low-dose minoxidil has been used as an off-label treatment in both female and male pattern hair loss with good clinical effectiveness and safety.3, 6, 7, 11-18 This treatment potentially limits localized scalp side effects, provides good compliance, and allows for a higher drug concentration in hair follicles which maximizes treatment response due to its higher bioavailability by liver sulfotransferase.3, 6 In the current study, we aim to compare the effectiveness of oral and topical minoxidil in improving AGA.
  • Methods: Sixty-five AGA patients were randomly allocated to receive either 5% topical solution or 1 mg/day oral minoxidil for 6 months. Treatment efficacy was evaluated by measuring hair diameter, photographic assessment, and patient self-assessment questionnaires. The safety of treatment was checked through history taking and physical examination
  • Results: Both topical and oral minoxidil groups showed significant improvement in hair diameter after 6 months of treatment (p < 0.001). However, there was no significant difference between the two groups. The photographic assessment demonstrated a significant improvement in hair density in the topical minoxidil group in all marked points located at 12 cm (p = 0.025), 16 cm (p = 0.034), and 24 cm (p = 0.014) distance from the glabella but not in the oral minoxidil group. Nevertheless, the difference between the two groups was not significant. In each group, over 60% of patients expressed satisfaction with their treatments, and no significant difference was detected between the two groups
  • Conclusion: Although topical minoxidil has a better overall therapeutic effect than 1 mg oral minoxidil, the difference between the two groups was not significant. Therefore, 1 mg oral minoxidil may be as effective and safe as standard topical minoxidil in female and male pattern hair loss.
  • Keywords: low-dose oral minoxidil androgenetic alopecia