Bicalutamide associated with oral Minoxidil for the treatment of female baldness

Phase 2

• Conditions: Alopecia; Hair diseases

• Registration Number: RBR-2q4ht7r
• Lead Sponsor: Faculdade de Medicina de Botucatu - Universidade Estadual Paulista

Brief Summary

Introduction: drugs with antiandrogenic action are frequently used in the treatment of Female Pattern Alopecia (FPA), despite the low level of evidence supporting this recommendation. There is growing interest in the use of bicalutamide for this purpose. However, the efficacy of bicalutamide for treating APF has not yet been evaluated in randomized clinical trials. Objectives: To evaluate the efficacy, safety, and tolerability of bicalutamide at a dose of 25 mg/day associated with oral minoxidil at a dose of 1 mg/day compared to minoxidil 1 mg/day as monotherapy, for 24 weeks, in the treatment of APF. Methods: randomized, controlled, double-blind clinical trial, involving 74 women, between 19 and 59 years old, with APF (Sinclair II – IV). Participants were randomized (1:1) into two groups: bicalutamide 25mg/day and oral minoxidil 1mg/day (Group BM); or placebo in oral capsule once a day and oral minoxidil 1mg/day (Group PM) for 24 weeks. The primary outcome consisted of variation in hair density in the target region. Secondary outcomes were clinical photographic assessment, quality of life scale, hair loss scale, subjective scale of perception of volume improvement and satisfaction with treatment, heart rate, blood pressure and adverse effects. Result: sixty-four participants completed the study, 32 from the BM group and 32 from the PM group. The groups were homogeneous in terms of demographic data and severity of APF. The variation in thread density showed no difference between the groups (p=0.71). There was an average increase of 18.1 (95% CI 3.6-32.7) hairs/cm² in the BM group and 21.5 (95% CI 8.1-34.2) hairs/cm² in the PM group. The most reported adverse effect was facial hypertrichosis, with a lower frequency in the BM group (58.1%) compared to the PM group (84.4%) (P=0.02). There were no differences between the groups in terms of heart rate variation, blood pressure and other adverse effects. Limitations: short follow-up period (24 weeks). Conclusion: bicalutamide at a dose of 25 mg per day associated with oral minoxidil 1 mg did not promote additional improvement in the treatment of APF when compared to oral minoxidil 1 mg per day after 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-26
• Study Start: 2024-07-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified