Skip to content

A clinical trial to study the effect of 1.5 % Aminexil and 5 % Minoxidil topical solution vs 5 % Minoxidil topical solution in male pattern hair loss

A single center, randomized, double-blind study to assess the efficacy and safety of fixed dose 1.5 % Aminexil and 5 % Minoxidil topical solution vs 5 % Minoxidil topical solution in male pattern hair loss

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001856
Enrollment
40
Registered
2011-07-01
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 pattern of hair loss

Interventions

Intervention1: Hair 4 u: fixed dose 1.5% Aminexil and 5% Minoxidil topical solution applied twice daily for 24 weeks Control Intervention1: 5% Minoxidil topical solution: 5% Minoxidil topical solution

Sponsors

Glenmark Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male patients of age more than 18 to 50. Presence of androgenetic alopecia based on the Norwood Hamilton Scale Written informed consent by patient. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving. Use of the following during the 6 months prior to screening: ?X Minoxidil (oral or topical) ?X Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months. ?X Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens) ?X Anabolic steroids ?X Lithium and phenothiazines Use of systemic steroids for more than 14 days within the past 2 months prior to enrollment in the study. Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year. Known sensitivity to the investigational product

Design outcomes

Primary

MeasureTime frame
Grade of balding based on hamilton scale and photographs Hair Density Anagen and Telogen ratio Timepoint: 12-24 weeks

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr CR Srinivas
chakravarthi.srinivas@yahoo.com

Outcome results

None listed

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