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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-8sm6kkk Comparison between treatment with Oral Minoxidil at doses of 1 mg per day and 2 mg per day in the treatment of Female Ba...


                                Date of registration:
                                
                                    04/04/2025                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    04/04/2025                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Oral Minoxidil 1 mg versus Oral Minoxidil 2 mg for treatment of Female Pattern Alopecia: a randomized, double-blind clinical trial

                                        

                                        
pt-br

                                        
Minoxidil Oral 1 mg versus Minoxidil Oral 2 mg para tratamento da Alopecia de Padrão Feminino: ensaio clínico duplo-cego randomizado

                                        

                                        
es

                                        
Oral Minoxidil 1 mg versus Oral Minoxidil 2 mg for treatment of Female Pattern Alopecia: a randomized, double-blind clinical trial

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1320-2121
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Comparison between treatment with Oral Minoxidil at doses of 1 mg per day and 2 mg per day in the treatment of Female Baldness
    
                                                
    
                                                    
    pt-br
    
                                                    
    Comparação entre o tratamento com Minoxidil Oral nas doses de 1 mg por dia e 2 mg por dia no tratamento da Calvície Feminina
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    77572924.4.0000.0320
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    6.686.213
      
                                                    Issuing authority:
                                                    Comitê de Ética em Pesquisa do Hospital Universitário Maria Aparecida Pedrossian - HUMAP/UFMS
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Clinica Sanabria Transplante e Restauração Capilar 
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Clinica Sanabria Transplante e Restauração Capilar 
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Clinica Sanabria Transplante e Restauração Capilar 
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Female pattern alopecia
    
                                                
    
                                                
    pt-br
    
                                                
    Alopécia de padrão feminino
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                        
    
                                                
    en
    
                                                
    
                                                    C17
                                                    Skin and Connective Tissue Diseases
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C17
                                                    Doenças da Pele e do Tecido Conjuntivo
                                                
    
                                                
                                                                                    
     
    
                                    
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    Specific descriptors:
    
                                        
    
                                                
    en
    
                                                
    
                                                    C17.800.329.937.122
                                                    Alopecia
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C17.800.329.937.122
                                                    Alopecia
                                                
    
                                                
                                            
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    This is a planned, controlled, double-blind, parallel, monocentric clinical trial with a 24-week longitudinal follow-up. Eighty female patients aged between 18 and 60 years with a diagnosis of female pattern alopecia, classified on the Sinclair scale from II to IV, were selected. The patients were divided into two groups of 40 patients each. During the first 30 days, patients in both groups received half the target dose. In other words, patients in group A took one capsule of 1 mg oral minoxidil per day and increased to two capsules per day after 30 days. The same procedure was adopted for patients in group B, but the capsules contained only 0.5 mg. The capsules containing minoxidil were prepared by a compounding pharmacy.
    
                                                
    
                                                
    pt-br
    
                                                
    Trata-se de um ensaio clínico randomizado, controlado, duplo-cego, paralelo e monocêntrico, de seguimento longitudinal de 24 semanas. Foram selecionadas 80 pacientes do sexo feminino, com idade entre 18 e 60 anos com diagnóstico de alopecia de padrão feminino, classificados na escala de Sinclair de II a IV. As pacientes foram dividas de forma randomizado em dois grupos de 40 pacientes. Durante os primeiros 30 dias as pacientes de ambos os grupos usaram metade da dose alvo. Ou seja, as pacientes do grupo A ingeriram uma cápsula de minoxidil oral 1 mg ao dia e aumentaram para duas cápsulas ao dia após 30 dias. O mesmo procedimento foi adotado para as pacientes do grupo B, porém as cápsulas continham apenas 0,5 mg. As cápsulas com minoxidil foram confeccionados por farmácia de manipulação.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
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                                                        D03.383.621.493
                                                        Minoxidil
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        D03.383.621.493
                                                        Minoxidil
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruitment completed
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        06/01/2024                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                80
                                                F
                                                18 Y
                                                60 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Females; age between 18 and 60 years; diagnosis of female pattern alopecia classified between grades II and IV on the Sinclair scale
    
                                                
    
                                                
    pt-br
    
                                                
    Sexo feminino; idade entre 18 e 60 anos; diagnóstico de alopecia de padrão feminino classificadas entre os graus II a IV da escala de Sinclair
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    Patients who have undergone previous treatment for hair loss in the last 6 months; patients diagnosed with systemic arterial hypertension, heart disease or kidney disease; patients with other causes of hair loss; presence of dermatoses on the scalp
    
                                                
    
                                                
    pt-br
    
                                                
    Pacientes que realizaram tratamento prévio para queda de cabelo nos últimos 6 meses; pacientes com diagnóstico de hipertensão arterial sistêmica, doenças cardíacas ou doenças renais; portadoras de outras causas de queda de cabelo; presença de dermatoses no couro cabeludo
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                1
                                                Treatment
                                                Parallel
                                                2
                                                Double-blind
                                                Randomized-controlled
                                                4
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        An increase in terminal hair density in the target area is expected, greater in the group receiving oral minoxidil 2 mg per day when compared with the group receiving oral minoxidil 1 mg per day. The evaluation was performed by counting terminal hairs using trichoscopic photography before treatment with Fotofinder handyscope equipment. This same parameter was reassessed in another consultation after 24 weeks of treatment. Hair counting was performed using specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany). Hairs with a thickness greater than 0.04 mm were considered terminal hairs.
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Espera-se encontrar aumento da da densidade de fios terminais na área-alvo, maior no grupo com minoxidil oral 2 mg por dia quando comparado com o grupo em uso de minoxidil oral 1 mg por dia. A avaliação foi realizada pela contagem de fios terminais por fotografia tricoscópica pré-tratamento com equipamento Fotofinder handyscope. Esse mesmo parâmetro foi reavaliados em consulta ambulatorial após 24 semanas de tratamento. A contagem dos fios foi realizada com auxílio de software específico (TrichoLAB hair to hair matching tecnology, Bad Birmach, Germany). Foram considerados terminais fios com espessura maior que 0,04 mm.
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    An increase in total hair density is expected in the target area. The evaluation was performed by counting the total number of hairs in the pre-treatment trichoscopic photograph with Fotofinder handyscope equipment. This same parameter was reassessed in an outpatient consultation after 24 weeks of treatment. The hair count was performed with the aid of specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany).
                                                
    
                                                
    
                                                
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                                                    Espera-se aumento da densidade total de fios na na área-alvo. A avaliação foi realizada pela contagem da quantidade total de fios na fotografia tricoscópica pré-tratamento com equipamento Fotofinder handyscope. Esse mesmo parâmetro foi reavaliado em consulta ambulatorial após 24 semanas de tratamento. A contagem dos fios foi realizada com auxílio de software específico (TrichoLAB hair to hair matching tecnology, Bad Birmach, Germany).
                                                
    
                                                
    
                                                
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                                                    Overall improvement in hair coverage assessed by standardized clinical photography. Patients were asked to maintain the same hair style, color, length, and cut throughout the study. The standardized photographs were evaluated by 2 dermatologists blinded about the treatment. Each dermatologist compared the baseline photograph with the 24-week photograph and used a 7-point comparison scale: marked worsening (-3), moderate worsening (-2), slight worsening (-1), no change (0), slight improvement (+1), moderate improvement (+2), and marked improvement (+3).
                                                
    
                                                
    
                                                
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                                                    Melhora global da cobertura capilar avaliada através de fotografia clínica padronizada. Os pacientes foram solicitados a manter o mesmo estilo, cor, comprimento e corte de cabelo durante o estudo. As fotografias padronizadas foram avaliadas por 2 dermatologistas cegos quanto ao tratamento. Cada dermatologista comparou a foto inicial com a de 24 semanas e usou uma escala de comparação de 7 pontos: grande piora (-3), moderada piora (-2), leve piora (-1), sem alteração (0), leve melhora (+1), moderada melhora (+2) e grande melhora (+3).
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Marcelo Zanolli Medeiros
                                                
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                                                            Address:
                                                            Rua Doutor Eduardo Machado Metelo, 393 - Chácara Cachoeira
                                                        
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                                                            City: 
                                                            Campo Grande / Brazil
                                                        
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                                                            Zip code:
                                                            79040-830
                                                        
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                                                    Phone:
                                                    +55(67)981809696
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Clinica Sanabria Transplante e Restauração Capilar 
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Marcelo Zanolli Medeiros
                                                
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                                                            Address:
                                                            Rua Doutor Eduardo Machado Metelo, 393 - Chácara Cachoeira
                                                        
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                                                            City:
                                                            Campo Grande / Brazil
                                                        
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                                                            Zip code:
                                                            79040-830
                                                        
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                                                    Phone:
                                                    +55(67)981809696
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Clinica Sanabria Transplante e Restauração Capilar 
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Marcelo Zanolli Medeiros
                                                
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                                                            Address:
                                                            Rua Doutor Eduardo Machado Metelo, 393 - Chácara Cachoeira
                                                        
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                                                            City:
                                                            Campo Grande / Brazil
                                                        
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                                                            Zip code:
                                                            79040-830
                                                        
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                                                    Phone:
                                                    +55(67)981809696
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Clinica Sanabria Transplante e Restauração Capilar 
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


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