NCT01319370

Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia

Investigator-Initiated, Double Blind, Two-Armed, Placebo-Controlled, Randomized Clinical Trial With an Open-Label Extension Phase, to Investigate Efficacy of 5% Minoxidil Topical Foam Twice Daily in Men With Androgenetic Alopecia in the Temple and Vertex Region Concerning Hair Volume Over 24 / 104 Weeks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Natalie GARCIA BARTELS · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Minoxidil	1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
DRUG	vehicle of 5% Minoxidil topical foam	1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-03-21
• Last updated: 2013-11-07

Locations

1 site across 1 country: Germany