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Clinical Trial in Females With Female Pattern Hair Loss

NCT01145625 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2014-05-22

Study results available
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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.

Conditions

Interventions

DRUG

5% Minoxidil

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

DRUG

2% Minoxidil

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

Sponsors & Collaborators

  • Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

    lead INDUSTRY

Principal Investigators

  • Clare Kendall, MA · Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Canada
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01145625 on ClinicalTrials.gov