Bicalutamide associated with oral Minoxidil for the treatment of female baldness

Efficacy and safety of Bicalutamide 25 mg associated with Minoxidil 1 mg oral versus Minoxidil 1 mg oral for treating female pattern Alopecia: double-blind and randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2q4ht7r

Enrollment

Unknown

Registered

2024-07-01

Start date

2022-09-12

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

Hair diseases

Interventions

This is a randomized double-blind multicenter study, carried out in 2 centers, with HCFMB being the coordinating center, evaluating whether the treatment of female pattern alopecia in women over 18 ye

D26.660

D03.383.621.493

D06.347.065

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with Female Pattern Alopecia (stages II, III, IV and V of the Sinclair Scale); patients with a minimum age of 18 years and a maximum age of 60 years; female patients

Exclusion criteria

Exclusion criteria: Any type of previous alopecia treatment in the past 4 months; patients with diagnosis of Systemic Arterial Hypertension; cardiopaths patients; hepatophats patients; nephropats patients; patients with any other cause of hair loss besides Female Pattern Hair Loss; patients with pregnancy intention in the next 12 months; patients in fertile age that wont agree in the use of secure contraceptive methods; patients who, during the clinical trial, present an increase in liver enzymes greater than two and a half times the upper limit of normality

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: Variation in hair density in the target area: all hairs in the shaved target area photographed by trichoscopy were counted before the start of treatment and after 24 weeks. There was an expectation of an increase in the average total hair density (standard deviation) of 12 (15) hairs/cm2 in the group that used Placebo associated with Minoxidil and 24 (15) hairs/cm2 in the group that used Bicalutamide associated with Minoxidil;Outcome found 1: There was no difference in the variation in hair density between the Bicalutamide associated with Minoxidil and Placebo associated with Minoxidil groups (p=0.71). There was an average increase of 18.1 (95% CI 3.6-32.7) hairs/cm² in the Bicalutamide group associated with Minoxidil and 21.5 (95% CI 8.1-34.2) hairs/cm² in the Placebo group associated with Minoxidil.	—

Measure

Time frame

Expected outcome 1: Variation in hair density in the target area: all hairs in the shaved target area photographed by trichoscopy were counted before the start of treatment and after 24 weeks. There was an expectation of an increase in the average total hair density (standard deviation) of 12 (15) hairs/cm2 in the group that used Placebo associated with Minoxidil and 24 (15) hairs/cm2 in the group that used Bicalutamide associated with Minoxidil;Outcome found 1: There was no difference in the variation in hair density between the Bicalutamide associated with Minoxidil and Placebo associated with Minoxidil groups (p=0.71). There was an average increase of 18.1 (95% CI 3.6-32.7) hairs/cm² in the Bicalutamide group associated with Minoxidil and 21.5 (95% CI 8.1-34.2) hairs/cm² in the Placebo group associated with Minoxidil.

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Secondary

Measure	Time frame
No secondary outcomes were expected	—

Countries

Brazil

Contacts

Public ContactRicardo Liborio

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

ricardoliborio89@gmail.com+55(14)38801001

Outcome results

None listed

Source: REBEC (via WHO ICTRP)