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How effective is Minoxidil combined with either oral or local application of finasteride in men with baldness

Randomised, double blind clinical trial to assess the effectiveness of topical minoxidil (5%) and topical finasteride (0.1%) fixed-dose combination versus topical minoxidil (5%) and oral finasteride (1 mg/day) in grade II-IV androgenetic alopecia: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008250
Enrollment
72
Registered
2017-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Male patients with Grade II-IV androgenetic alopecia

Interventions

Intervention1: Topical Minoxidil 5% and Finasteride 0.1%: 1 ml twice daily for 6 months to be applied at the affected patch of baldness Control Intervention1: Topical Minoxidil 5% and Finasteride 1 mg

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-45 years 2. Sex: Male 3. Hamilton-Norwood scale grade II-IV 4. Informed consent obtained 5. Willing for follow up 6. Willing to agree to maintain same hair style, use same shampoo, and not to cut hair shorter than 1 inch length

Exclusion criteria

Exclusion criteria: 1. Treated with minoxidil/finasteride within last 1 month 2. Co-morbidities like diabetes, hypertension, thyroid disorder, heart disease, hepatic/kidney dysfunction 3. Immunosuppression in any form 4. Other dermatological scalp disorders 5. History of drug hypersensitivity, breast disorder, testicular disorder

Design outcomes

Primary

MeasureTime frame
Assessment of hair regrowth using Hamilton-Norwood ScaleTimepoint: baseline, 6th follow up at end of 6 months treatment—

Secondary

MeasureTime frame
Any side effect detected by physicianTimepoint: at all follow ups;Any symptoms complained of by patientTimepoint: at all monthly follow ups for 6 months;Investigatorâ??s assessment of hair growth (5 point scale)Timepoint: baseline, monthly for next 6 follow ups;Patientâ??s global assessment of disease activity improvement (5 point Likert scale)Timepoint: at all monthly follow ups for 6 months;Quality of life in patients will be assessed by a validated vernacular version of Dermatology Life Quality Index (DLQI)Timepoint: baseline, 6th follow up at end of 6 months treatment;Subjectsâ?? self assessment of hair growth (5 point scale)Timepoint: at all monthly follow ups for 6 months—

Countries

India

Contacts

Public ContactAmrita Sil

Department of Dermatology Venereology and Leprosy Medical College Kolkata

debatri.datta@gmail.com9903726859

Outcome results

None listed

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