RBR-7kp4x6p Assessment of the superiority of using Bicalutamide 50 mg orally versus Spironolactone 100 mg orally for treatment of Fe...

Date of registration: 03/26/2025 ^(mm/dd/yyyy)
Last approval date : 03/26/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1320-0340

• Public title:

  en

  Assessment of the superiority of using Bicalutamide 50 mg orally versus Spironolactone 100 mg orally for treatment of Female Baldness

  pt-br

  Avaliar a superioridade do uso de Bicalutamida 50 mg via oral versus Espironolactona 100 mg oral para tratamento da Calvície Feminina

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 78436524.4.0000.0320
    Issuing authority: Plataforma Brasil
  • 6.797.198
    Issuing authority: Comitê de Ética em Pesquisa do Hospital Universitário Maria Aparecida Pedrossian - HUMAP da Universidade Federal de Mato Grosso do Sul

Sponsors

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

Health conditions

• Health conditions:

  en

  Alopecia

  pt-br

  Alopecia

• General descriptors for health conditions:

  en

  C17 Skin and Connective Tissue Diseases

  pt-br

  C17 Doenças da Pele e do Tecido Conjuntivo

• Specific descriptors:

  en

  C17.800.329.937.122 Alopecia

  pt-br

  C17.800.329.937.122 Alopecia

Interventions

• Interventions:

  en

  This is a double-blind, randomized, parallel and controlled, monocentric clinical study with a 24-week longitudinal follow-up involving 74 patients with female pattern alopecia. Patients will be randomized into two groups, with 37 patients receiving bicalutamide 50 mg, 1 capsule per day, and 37 patients receiving spironolactone 100 mg, 1 capsule per day.

  pt-br

  Trata-se de um estudo clínico duplo-cego, randomizado, paralelo e controlado, monocêntrico com seguimento longitudinal de 24 semanas envolvendo 74 pacientes com alopecia de padrão feminino. As pacientes serão randomizadas em dois grupos, sendo que 37 pacientes receberão bicalutamida 50 mg 1 cápsula ao dia e 37 pacientes receberão espironiolactona 100 mg 1 cápsula ao dia.

• Descriptors:

  en

  D06.347.065.500 Nonsteroidal Anti-Androgens

  pt-br

  D06.347.065.500 Drogas Antiandrogênicas não Esteroides

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 09/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  74	F	17 Y	60 Y

• Inclusion criteria:

  en

  Females; age between 17 and 60 years; diagnosis of female pattern alopecia stages II to V of the Sinclair scale

  pt-br

  Gênero feminino; idade entre 17 e 60 anos; diagnóstico de alopecia de padrão feminino estágios II a V da escala de Sinclair

• Exclusion criteria:

  en

  Patients who have undergone previous treatment for hair loss in the last four months; diagnosed with high blood pressure, heart disease, liver disease or kidney disease; with other causes of hair loss

  pt-br

  Pacientes que realizaram tratamento prévio para queda de cabelo nos últimos quatro meses; diagnóstico de hipertensão arterial, cardiopatias, hepatopatias ou nefropatias; portadoras de outras causas de queda de cabelo

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  It is expected to find an increase in hair density in the target area, greater in the group using bicalutamide when compared to the group using spironolactone, comparing pre-treatment trichoscopic photography (in the central parietal region at the intersection point between the sagittal median line and the line connecting the auricular tragus) with trichoscopic photography of the same region after 24 weeks of treatment.

  pt-br

  Espera-se encontrar um aumento da densidade de fios de cabelo na área-alvo, maior no grupo em uso da bicalutamida quando comparado ao grupo em uso de espironolactona, comparando-se fotografia tricoscópica pré-tratamento (na região parietal central no ponto de interseção entre linha mediana sagital e linha que liga os trágus auriculares) com a fotografia tricoscópica da mesma região após 24 semanas de tratamento.

• Secondary outcomes:

  en

  To evaluate possible side effects associated with bicalutamide, such as elevated transaminases, headache and transient amenorrhea. Liver laboratory evaluation (transaminases, alkaline phosphatase and gamma glutamyl transferase) will be performed before treatment and after 24 weeks and patients will be asked about the occurrence of headache and menstrual irregularities.

  pt-br

  Avaliar possíveis efeitos colaterais associados a bicalutamida, como elevação de transaminases, cefaleia e amenorreia transitória. Será realizada a avaliação laboratorial hepática (transaminases, fosfatase alcalina e gama glutamil transferase) pré-tratamento e após 24 semanas e as pacientes serão questionadas sobre ocorrência de cefaleia e irregularidades menstruais.

Contacts

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

Additional links:

• Download in ICTRP format