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A Randomized Comparative Study of Topical Minoxidil 5%, Low-Dose Oral Minoxidil, and Topical Minoxidil Combined with Oral Spironolactone in Female Pattern Hair Loss

EFFICACY AND SAFETY OF TOPICAL MINOXIDIL 5 PERCENT ALONE VERSUS ORAL MINOXIDIL VERSUS TOPICAL MINOXIDIL 5 PERCENT WITH ORAL SPIRONOLACTONE IN FEMALE PATTERN HAIR LOSS : A RANDOMISED CLINICAL COMPARATIVE TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101257
Enrollment
120
Registered
2026-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: L649- Androgenic alopecia, unspecified

Interventions

Intervention1: ORAL MINOXIDIL: To give low dose minoxidil (1.25mg), daily once orally for 6 months Intervention2: ORAL SPIRONOLACTONE WITH TOPICAL MINOXIDIL 5 percent: To give 25mg of tablet spironola

Sponsors

IMS SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All females aged between 18-45 years with female pattern hair loss; Ludwig scale II- III. 2. Any females who completed 4 months of therapy.

Exclusion criteria

Exclusion criteria: 1.Any relative contraindications to oral spironolactone; such as insufficiency of heart, liver, kidney, low blood pressure or elevated blood potassium levels. 2.Any relative contraindications to oral minoxidil; such as any history of bleeding disorders, use of anticoagulants or active infection at the targeted area. 3.Use of topical or systemic medications that influence hair growth within the last 6 months 4.Pregnancy and lactation. 5.Patients planning to conceive within a year 6.Presence of any other forms of alopecia (alopecia areata, frontal fibrosing alopecia, telogen effluvium)

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss To assess the safety of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss. Timepoint: 6 months—

Secondary

MeasureTime frame
To assess the safety of topical minoxidil alone, oral minoxidil in addition with 5% topical minoxidil and oral spironolactone with 5% topical minoxidil for female pattern hair loss Timepoint: 6 months—

Countries

India

Contacts

Public ContactSreya Sibbadi

IMS & SUM Hospital

ajayajenabbsr@gmail.com09769804945

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026