A study for Evaluation of effectiveness and Safety of Minoxidil (5%) plus Finasteride (0.1%) Solution in Adult Male Patients with Androgenetic Alopecia

A Double blind, Randomized, Placebo controlled, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil (5%) plus Finasteride (0.1%) Lipid Solution in Comparison with Minoxidil (5%) Lipid Solution and Finasteride (0.1%) Lipid solution in Adult Male Patients with Androgenetic Alopecia - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006724

Enrollment

160

Registered

2016-03-09

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: L649- Androgenic alopecia, unspecified

Interventions

Intervention1: Arm A: Fixed dose combination of Minoxidil (5%) plus Finasteride (0.1%) as lipid solution. : Dose: 01 ml

Frequency: twice daily

Mode of Administration: Topically Duration of treatment: 24 weeks Control Intervention1: Arm B: Minoxidil (5%) lipid solution. Arm C: Finasteride (0.1%) lipid solution. Arm D: Matching lipid solution

Mode of Administration: Topically Duration of treatment: 24 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients in good general physical and mental health, with Androgenetic alopecia. 2. Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Concomitant dermatological disorders on the scalp other than Androgenetic alopecia. 2. Serious cardiovascular diseases (uncontrolled hypertension, angina pectoris, myocardial infarction, etc.), renal diseases or hepatic diseases. 3. History of drug hypersensitivity (including contact dermatitis to cosmetics), breast disorders (including gynecomastia, breast enderness) or testicular disorders (testicular growth, testicular pain). 4. History of treatment with a systemic or locally acting medication which may interfere with the study objectives, such as Minoxidil treatment in the 06 months prior to dosing, Finasteride treatment in the 12 months prior to dosing, or treatment with other investigational hair growth products in the 06 months prior to dosing 5. Ongoing use of prohibited medications (as specified in the protocol) 6. Use of any investigational product within 03 months prior dosing of study drug 7. Judged by the investigator as otherwise being unsuitable for participation in this trial.

Design outcomes

Primary

Measure	Time frame
1) Change from baseline in Target Area Hair Count (TAHC) 2) Change in the Subject Self Assessment (SSA) Score Timepoint: Baseline to week 24	—

Secondary

Measure	Time frame
1) Change in the Investigator assessment score 2) Evaluation of pharmacokinetic profile Timepoint: At the end of study	—

Countries

India

Contacts

Public ContactDr Manjunath K

Lambda Therapeutic Research Ltd

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

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