A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).

This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).

Inclusion Criteria -

• Men who have a presentation of androgenetic alopecia (Norwood II - V).
• Age between 18 to 60 years of age (both inclusive).
• Have no abnormal findings during physical examination.
• Able to comply with the study procedures in the opinion of the PI/CI.
• Able to give written consent for participation in the study.

Exclusion Criteria -

• Known hypersensitivity or idiosyncratic reaction to the API´s.
• Clinical diagnosis of non-AGA forms of alopecia.
• History of hair transplants.
• Subject having dyed or bleached hair 12 months prior to study start.
• Use of any topical product in the target region in the last 6 months.
• A medical history of receiving chemotherapy/cytotoxic agents.
• Uncontrolled hypertension.
• Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer).
• Hormonal diseases such as thyroid disorders or diabetes.
• Liver and kidney disease.
• Smokers.
• Drug or alcohol abuse within 12 months.
• No written consent.
• The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.