- Jue May 16, 2019 9:28 pm
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MINOXIDIL 1 MG ORALLY VERSUS MINOXIDIL 5% SOLUTION TOPICALLY FOR TREATMENT OF FEMALE PATTERN HAIR LOSS: A RANDOMIZED CLINICAL TRIALP.
RamosÂ¹; R. SinclairÂ²; M. KasprzakÂ³; H. MiotÂ¹Departamento de Dermatologia e Radioterapia, UNESP, Botucatu, SP, Brazil Â¹Sinclair Dermatology, Melbourne, VIC, Australia Â²TrichoLAB, Bad Birmbach, Germany Â³
Introduction Topical minoxidil is the only FDA approved drug for female pattern hair loss (FPHL). Many patients discontinue treatment prematurely due to lack of efficacy, intolerance or altered hair texture.
Objective To compare the efficacy, safety and tolerability of once daily minoxidil 1 mg orally versus once daily minoxidil 5% solution applied topically in FPHL.
Material & Methods A 24-week, prospective, ran-domized, open-label, parallel, two-arm compara-tive, evaluator-blinded study conducted in a single center from January of 2017 through March of 2018 including 52 women (18-65 years old) with FPHL.Patients with FPHL were randomly assigned, in a 1:1 ratio, to receive once daily minoxidil 1 mg orally or once a day minoxidil 5% solution ap-plied topically.The primary endpoint was change from baseline in hair density from a target area at week 24. Secondary endpoints were terminal hair density, global photographic assessment by three group-blinded evaluators, hair shedding score, and the Women's Androgenetic Alopecia Quality of Life Questionnaire (WAA-QoL).
Results Fifty-two women with FPHL with a mean (sd) age: 44 (12) years-old, were en-rolled and randomly assigned to receive once daily minoxidil 1 mg orally (26 patients) or daily minoxidil 5% solution applied topical-ly (26 patients). Participants of both groups had improvement of hair density in the target area (p<0.01), without difference between the groups (p=0.10): oral 12% (CI95% 8.0-16.1%) and topical 7.2% (CI95% 1.5-12.9%). There was improvement on terminal hair density, on the evaluation of global photographic assessment and on the WAA-Qol score with no difference between the groups (p>0.08). The reduction on the hair shedding score was more intense in the oral group (p<0.01). Hypertrichosis was more prevalent in the oral group (27%) than the topical (4%). Heart rate increased 10% in the oral group (p<0.01), without tachycardia. There was no difference on the variation on the blood pressure between the groups (p=0.51).
Conclusions Oral 1mg minoxidil was safe and well tolerated in the treatment of FPHL. Its effi-cacy did not differ from topical 5% minoxidil so-lution. It can be an option for patients with poor compliance to topical therapy.
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