Minoxidil 5 mg oral versus minoxidil 5% solução tópica para tratamento da alopecia androgenética masculina: ensaio clínico randomizado
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Data
2023-04-27
Autores
Penha, Mariana Alvares
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Universidade Estadual Paulista (Unesp)
Resumo
Fundamentos: Finasterida oral e minoxidil tópico são os únicos medicamentos aprovados pela Food and Drug Administration (FDA) para tratamento da alopecia androgenética (AAG) masculina. Recentemente, houve crescente interesse no uso do minoxidil oral em baixa dose (MOBD) como alternativa terapêutica. Entretanto, a eficácia do MOBD para tratamento da AAG masculina ainda não foi avaliada em ensaios clínicos comparativos. Objetivos: Avaliar eficácia, segurança, e tolerabilidade do minoxidil oral na dose de 5 mg/dia comparado ao minoxidil tópico 5%, duas vezes ao dia, por 24 semanas, no tratamento da AAG masculina. Métodos: Ensaio clínico randomizado, controlado, duplo-cego, envolvendo 90 homens, entre 18 e 55 anos, portadores de AAG, classificados na escala de Norwood-Hamilton em 3V, 4V ou 5V. Os participantes foram randomizados (1:1) em dois grupos: minoxidil oral 5 mg/d e solução placebo para uso tópico duas vezes ao dia; ou minoxidil 5% solução 1ml duas vezes ao dia e cápsula de placebo oral, por 24 semanas. O desfecho primário consistiu na variação da densidade de fios da região frontal e vértex. Desfechos secundários foram avaliação clínica fotográfica, frequência cardíaca, pressão arterial e efeitos adversos. Resultado: Sessenta e oito participantes completaram o estudo, sendo 33 do grupo minoxidil oral e 35 do grupo tópico. Os grupos foram homogêneos quanto aos dados demográficos e a gravidade da AAG. A variação da densidade (fios/cm2) de fios não mostrou diferença entre os grupos oral e tópico (p>0,3). Houve um incremento médio (EP) de 11,0 (3,6) na região frontal e 11,6 (3,2) no vértex para o grupo oral. O grupo tópico apresentou incremento de 8,0 (4,9) na região frontal e 4,9 (5,4) no vértex. De acordo com a análise fotográfica houve superioridade do minoxidil oral no vértex (p=0,038) mas não na região frontal (p= 0,245). O efeito adverso mais relatado foi hipertricose: 49% (grupo oral), e 25% (grupo tópico). Não houve diferença estatística entre os grupos quanto à variação da frequência cardíaca e pressão arterial. Limitações: Estudo conduzido durante a pandemia de COVID-19. Conclusão: Minoxidil oral 5mg/d promoveu melhora na densidade capilar sem diferença em relação ao minoxidil tópico 5%, após 24 semanas de tratamento da AAG masculina, com segurança e boa tolerabilidade. MOBD pode ser opção para pacientes intolerantes ou com baixa adesão ao minoxidil tópico. Registro: nº RBR-252w9r Financiamento: FUNADERM
Background: Oral finasteride and topical minoxidil are the only medications approved by the Food and Drug Administration (FDA) for male androgenetic alopecia (AGA). Recently, there has been a worldwide increased interest in low-dose oral minoxidil (LDOM) as an alternative. However, the efficacy of LDOM for male AGA is yet to be evaluated in comparative therapeutic trials. Objective: To compare the efficacy, safety, and tolerability of oral minoxidil 5mg per day versus 5% topical minoxidil twice daily for 24 weeks in the treatment of male AGA. Methods: Double-blind, placebo-controlled, randomized clinical trial involving 90 men with AGA between the ages of 18 and 55, classified in the Norwood-Hamilton scale as 3V, 4V, or 5V. The participants were randomized (1:1) into two groups: oral minoxidil 5mg per day and topical placebo solution; or 5% topical minoxidil 1mL twice daily and oral placebo for 24 weeks. The primary outcome was the change in hair density on the frontal and vertex regions of the scalp. The secondary outcomes were photographic evaluation, heart rate, blood pressure, and adverse events. Results: Sixty-eight patients completed the study - 33 from the oral minoxidil group and 35 from the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. The oral group showed an average (SE) improvement of 11.0 (3.6) hairs/cm2 on the frontal and 11.6 (3.2) hairs/cm2 on the vertex regions. The topical group showed an increment of 8.0 (4.9) hairs/cm2 on the frontal scalp and 4.9 (5.4) on the vertex hairs/cm2. There was no difference in hair density change between the groups (p>0.3). According to the photographic analysis, oral minoxidil was superior to topical on the vertex (p=0.038) but not on the frontal scalp (p=0.245). The most common adverse effect reported was hypertrichosis: 49% (oral group) and 25% (topical group). There was no difference in heart rate and blood pressure between the groups. Limitations: This study was conducted during the COVID-19 pandemic. Conclusion: Oral minoxidil 5mg per day was clinically superior to 5% topical minoxidil twice a day for male AGA on the vertex region after 24 weeks of treatment. LDOM has shown to be safe and well tolerated and, therefore, an option for patients who are either intolerant or non-compliant with the topical treatment. Registry: RBR-252w9r Funding: FUNADERM (Brazilian Dermatology Society Support Fund).
Background: Oral finasteride and topical minoxidil are the only medications approved by the Food and Drug Administration (FDA) for male androgenetic alopecia (AGA). Recently, there has been a worldwide increased interest in low-dose oral minoxidil (LDOM) as an alternative. However, the efficacy of LDOM for male AGA is yet to be evaluated in comparative therapeutic trials. Objective: To compare the efficacy, safety, and tolerability of oral minoxidil 5mg per day versus 5% topical minoxidil twice daily for 24 weeks in the treatment of male AGA. Methods: Double-blind, placebo-controlled, randomized clinical trial involving 90 men with AGA between the ages of 18 and 55, classified in the Norwood-Hamilton scale as 3V, 4V, or 5V. The participants were randomized (1:1) into two groups: oral minoxidil 5mg per day and topical placebo solution; or 5% topical minoxidil 1mL twice daily and oral placebo for 24 weeks. The primary outcome was the change in hair density on the frontal and vertex regions of the scalp. The secondary outcomes were photographic evaluation, heart rate, blood pressure, and adverse events. Results: Sixty-eight patients completed the study - 33 from the oral minoxidil group and 35 from the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. The oral group showed an average (SE) improvement of 11.0 (3.6) hairs/cm2 on the frontal and 11.6 (3.2) hairs/cm2 on the vertex regions. The topical group showed an increment of 8.0 (4.9) hairs/cm2 on the frontal scalp and 4.9 (5.4) on the vertex hairs/cm2. There was no difference in hair density change between the groups (p>0.3). According to the photographic analysis, oral minoxidil was superior to topical on the vertex (p=0.038) but not on the frontal scalp (p=0.245). The most common adverse effect reported was hypertrichosis: 49% (oral group) and 25% (topical group). There was no difference in heart rate and blood pressure between the groups. Limitations: This study was conducted during the COVID-19 pandemic. Conclusion: Oral minoxidil 5mg per day was clinically superior to 5% topical minoxidil twice a day for male AGA on the vertex region after 24 weeks of treatment. LDOM has shown to be safe and well tolerated and, therefore, an option for patients who are either intolerant or non-compliant with the topical treatment. Registry: RBR-252w9r Funding: FUNADERM (Brazilian Dermatology Society Support Fund).
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Palavras-chave
Alopecia, Alopecia androgenética, Ensaio clínico, Ensaio clínico controlado randomizado, Minoxidil, Minoxidil oral, Tratamento, Androgenetic alopecia, Clinical trial, Oral minoxidil, Randomized controlled trial, Treatment