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

NCT01319370 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-11-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319370 on ClinicalTrials.gov