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

Assessment of the superiority of efficacy of using Bicalutamide 50 mg orally versus Spironolactone 100 mg orally for treatment of Female Pattern Alopecia: double-blind and randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7kp4x6p

Enrollment

Unknown

Registered

2025-03-26

Start date

2023-09-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Interventions

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 rando

D06.347.065.500

Eligibility

Sex/Gender

Female

Age

17 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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.	—

Countries

Brazil

Contacts

Public ContactMarcelo Medeiros

Clinica Sanabria Transplante e Restauração Capilar

zanolli_marcelo@hotmail.com+55(67)981809696

Outcome results

None listed

Source: REBEC (via WHO ICTRP)