Conditions: Alopecia
Keywords: male pattern hair loss hair growth hair restoration Dutasteride Androgenetic alopecia safety efficacy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 120
Healthy volunteers: no

Brief summary:
This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of 0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who completes the full course of study treatment and the final study visit (Week 52; Visit 7) will be considered as study completion.

Detailed description:

Arms:
arm 1: Subjects will receive 1 capsule of Dutasteride 0.5 mg orally once daily for 52 weeks (12 months).

Interventions: intervention 1: Dutasteride 0.5 mg
Intervention descriptions: intervention 1: Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.

Protocol document: