Minoxidil 1 mg oral versus minoxidil 5% tópico para tratamento da alopecia de padrão feminino: ensaio clínico randomizado
Arquivos
Data
2019-10-17
Autores
Ramos, Paulo Müller
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
Introdução: Minoxidil tópico é o único medicamento com aprovação pelo FDA (Food and Drug Administration) para tratamento da alopecia de padrão feminino (APF). Muitas pacientes interrompem o tratamento prematuramente devido a falta de eficácia, intolerância ou por alteração na textura dos fios de cabelo. Minoxidil oral mostrou-se efetivo para tratamento da APF em estudo não controlado. Objetivo: Comparar eficácia, segurança e tolerabilidade do minoxidil 1 mg oral uma vez ao dia versus minoxidil 5% solução tópica uma vez ao dia no tratamento da APF. Métodos: Estudo prospectivo, randomizado, paralelo, comparativo, avaliador cego com duração de 24 semanas conduzido em um único centro de janeiro de 2017 a março de 2018 incluindo 52 mulheres (18-65 anos) com APF. Participantes foram randomizadas para receber minoxidil oral 1 mg ao dia ou minoxidil 5% tópico uma vez ao dia. O desfecho primário foi a variação na densidade de fios na área alvo. Desfechos secundários: variação na densidade de fios terminais na área alvo, escore na avaliação fotográfica panorâmica por avaliadores cegos, variação no escore da escala de queda, variação no escore do Women's Androgenetic Alopecia Quality of Life Questionnaire (WAA-QoL). Resultados: Participantes de ambos os grupos apresentaram melhora na densidade de fios na área alvo (p<0,01), porém, sem diferença entre os grupos (p=0,09): oral 12% (IC95%: 8,0 – 16,1%) e tópico 7,2% (IC95%: 1,5 - 12,9%). Houve melhora na densidade de fios terminais: oral 6% (IC95%: 2,9 – 8,6%) e tópico 2,7% (IC95%: -1,4 – 6,8%), sem diferença entre os grupos (p=0,17). A melhora na avaliação fotográfica panorâmica (p=0,16) e na variação do escore do WAA-QoL (p=0,09) também não foi diferente entre os grupos. A redução na escala de queda foi mais pronunciada no grupo oral em relação ao tópico (p<0,01). Hipertricose foi mais prevalente (p=0,02) no grupo oral (27%) que no tópico (4%). A frequência cardíaca de repouso aumentou 10% no grupo oral (p<0,01), sem taquicardia. Não houve diferença na variação de pressão arterial média entre os grupos (p=0,51). Conclusões: Minoxidil oral na dose de 1 mg foi eficaz e seguro para tratamento da APF por 24 semanas, sem diferença em relação ao minoxidil 5% tópico. O tratamento oral deve ser considerado como alternativa para pacientes intolerantes à terapia tópica.
Introduction: Topical minoxidil is the only FDA (Food and Drug Administration) approved drug for female pattern hair loss (FPHL). Many patients discontinue treatment prematurely due to lack of efficacy, intolerance or altered hair texture. Oral minoxidil was effective for FPHL in uncontrolled studies. Objectives: To compare the efficacy, safety and tolerability of once-daily treatment with 1 mg oral minoxidil versus once-daily 5% minoxidil solution applied topically for FPHL. Methods: A 24-week, prospective, randomized, open-label, parallel, two-arm comparative, evaluator-blinded study conducted in a single center from January 2017 through March 2018 including 52 women (18-65 years old) with FPHL. Participants were randomly assigned to receive once daily minoxidil 1 mg orally or once a day minoxidil 5% solution applied topically. The primary endpoint was change from baseline in hair density from a target area at week 24. Secondary endpoints were change in 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: Participants of both groups had improvement of hair density in the target area (p<0.01), without difference between the groups (p=0.09): oral 12% (CI95%: 8.0- 16.1%) and topical 7,2% (CI95%: 1.5-12.9%). There was improvement on terminal hair density: oral 6% (IC95%: 2.9 – 8.6%) and topical 2,7% (IC95%: -1.4 – 6.8%), with no difference between the groups (p=0.17). There was no difference on the evaluation of global photographic assessment (p=0.16) and on the WAA-Qol score (p=0.09) between the groups. The reduction on the hair shedding score was more intense in the oral group (p<0.01). Hypertrichosis was more prevalent (p=0.02) 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 minoxidil at a dose of 1 mg was effective and safe for treatment of FPHL for 24 weeks, with no difference from topical 5% minoxidil. Oral treatment should be considered as an alternative for intolerant patients to topical therapy
Introduction: Topical minoxidil is the only FDA (Food and Drug Administration) approved drug for female pattern hair loss (FPHL). Many patients discontinue treatment prematurely due to lack of efficacy, intolerance or altered hair texture. Oral minoxidil was effective for FPHL in uncontrolled studies. Objectives: To compare the efficacy, safety and tolerability of once-daily treatment with 1 mg oral minoxidil versus once-daily 5% minoxidil solution applied topically for FPHL. Methods: A 24-week, prospective, randomized, open-label, parallel, two-arm comparative, evaluator-blinded study conducted in a single center from January 2017 through March 2018 including 52 women (18-65 years old) with FPHL. Participants were randomly assigned to receive once daily minoxidil 1 mg orally or once a day minoxidil 5% solution applied topically. The primary endpoint was change from baseline in hair density from a target area at week 24. Secondary endpoints were change in 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: Participants of both groups had improvement of hair density in the target area (p<0.01), without difference between the groups (p=0.09): oral 12% (CI95%: 8.0- 16.1%) and topical 7,2% (CI95%: 1.5-12.9%). There was improvement on terminal hair density: oral 6% (IC95%: 2.9 – 8.6%) and topical 2,7% (IC95%: -1.4 – 6.8%), with no difference between the groups (p=0.17). There was no difference on the evaluation of global photographic assessment (p=0.16) and on the WAA-Qol score (p=0.09) between the groups. The reduction on the hair shedding score was more intense in the oral group (p<0.01). Hypertrichosis was more prevalent (p=0.02) 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 minoxidil at a dose of 1 mg was effective and safe for treatment of FPHL for 24 weeks, with no difference from topical 5% minoxidil. Oral treatment should be considered as an alternative for intolerant patients to topical therapy
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Palavras-chave
alopecia, mulher, alopecia de padrão feminino, alopecia androgenética, minoxidil, oral, tópico, tratamento, hipertricose, female pattern hair loss, androgenetic alopecia, topic, hypertrichosis, treatment