Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil + Finasteride Solution in Comparison with Minoxidil Solution in Adult Male Patients with Androgenic Alopecia

An Open Label, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil (5%) + Finasteride (0.1%) Lipid Solution in Comparison with Minoxidil (5%) Solution in Adult Male Patients with Androgenic Alopecia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000896

Enrollment

270

Registered

2010-02-02

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- Androgenic alopecia

Interventions

Intervention1: Fixed Dose Combination of Minoxidil (5%) + Finasteride (0.1%) Lipid Solution: 1 ml twice daily for 24 weeks Control Intervention1: Minoxidil (5%) Solution: 1 ml twice daily for 24 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: (1) Male 18 to 45 years of age, with androgenic alopecia with II to V grade on the modified Norwood Hamilton classification (2) Willingness to maintain the same hair style, approximate length, and hair color throughout the study (3) Subjects willing to provide written informed consent

Exclusion criteria

Exclusion criteria: (1) Concomitant dermatological disorders on the scalp (2) Serious cardiovascular diseases, renal diseases or hepatic diseases (3) History of drug hypersensitivity, breast disorders or testicular disorders (4) Wearing a wig or under gone surgical treatment for hair loss (5) Shaved scalp or undergoing topical scalp treatment (6) Clinically significant abnormalities on physical examination or laboratory tests (7) History of medication interfering with the study objectives (8) Ongoing use of prohibited medications

Design outcomes

Primary

Measure	Time frame
Change in the investigator assessment score for hair growth and scalp coverageTimepoint: Each visit from enrollment onwards	—

Secondary

Measure	Time frame
(1)Patients assessment of hair growth and loss by hair growth questionnaire. (2)Change in global photographic assessment for hair growth by 7 point scale. (3)Any adverse event reported voluntarily, observed or enquired. (4)Any clinically significant change in the value of laboratory, vital signs and physical examination compared to baseline.Timepoint: (1)Each visit from first follow-up onwards. (2)Baseline, at end of 12 weeks and at the end of study visit. (3)Each visit from enrollment onwards. (4)Each visit from enrollment onwards.	—

Measure

Time frame

(1)Patients assessment of hair growth and loss by hair growth questionnaire. (2)Change in global photographic assessment for hair growth by 7 point scale. (3)Any adverse event reported voluntarily, observed or enquired. (4)Any clinically significant change in the value of laboratory, vital signs and physical examination compared to baseline.Timepoint: (1)Each visit from first follow-up onwards. (2)Baseline, at end of 12 weeks and at the end of study visit. (3)Each visit from enrollment onwards. (4)Each visit from enrollment onwards.

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Countries

India

Contacts

Public ContactDr Hardik Pathak

Intas Pharma

hardik_pathak@intaspharma.com66117407

Outcome results

None listed

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