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Efficacy and safety of oral bicalutamide in combination with 5% topical minoxidil in the treatment of female pattern hair loss

Comparing the efficacy and safety of 5% topical minoxidil combined with oral bicalutamide versus 5% topical minoxidil in the treatment of female pattern hair loss: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085182
Enrollment
44
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: L648- Other androgenic alopecia

Interventions

Intervention1: Oral bicalutamide with topical minoxidil: Oral bicalutamide at a dose of 25 mg/day is combined with topical 5% minoxidil once a day application for a period of 3 months Control Interven

Sponsors

Department of Dermatology Bangalore Medical College Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Females diagnosed with Ludwig stage II/ III FPHL through clinical evaluation and by trichoscopy.

Exclusion criteria

Exclusion criteria: Patients who are pregnant or lactating. Patients who have been on any form of topical or oral anti-androgen therapy in the three months prior to screening. Patients with pre-existing liver disease.

Design outcomes

Primary

MeasureTime frame
1. Improvement in Sinclair scale 2. Reversal of trichoscopic changes 3. Improvement in scalp coverage on clinical photographs 4. Patient satisfaction recorded using Likert s 5-point scale 5. Abnormal changes in complete blood count, liver function test, and renal function test Timepoint: Baseline and 3 months after starting treatment

Secondary

MeasureTime frame
Improvement in acne, seborrhea, hirsutism, if present. Timepoint: Baseline and 3 months after starting treatment

Countries

India

Contacts

Public ContactShilpa K

Bangalore Medical College Hospital and Research Institute

shilpakvinod1980@gmail.com9886553646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026