CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 322 enrolled
Drug / intervention
5% Minoxidil +1 moredrug
Likely dose
5% Minoxidil 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01145625
NCT01145625Phase 3Completed

A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.·interventional·Posted Jun 16, 2010·Updated May 22, 2014

In Brief

A Phase 3 clinical trial evaluating 5% Minoxidil and 2% Minoxidil for Alopecia. Completed, enrolled 322 participants across 12 sites in 5 countries.

Detailed Summary

This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day. This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks). This trial will determine if the benefit of using either study product outweighs the risks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlopecia
CountriesCanada, France, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 16, 2010
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.0 years ago

Interventions

5% Minoxidildrug

half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks

2% Minoxidildrug

one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks