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Clinical Trial in Females With Female Pattern Hair Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145625
First Posted: June 16, 2010
Last Update Posted: May 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
Results First Submitted: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Alopecia
Interventions: Drug: 5% Minoxidil
Drug: 2% Minoxidil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
2% MTS

2% Minoxidil Topical Solution

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

5% MTF

5% Minoxidil Topical Foam

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


Participant Flow:   Overall Study
    2% MTS   5% MTF
STARTED   161   161 
COMPLETED   137   130 
NOT COMPLETED   24   31 
Lost to Follow-up                8                9 
Adverse Event                6                4 
Protocol Violation                3                1 
Withdrawal by Subject                7                16 
Pregnancy                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.

Reporting Groups
  Description
2% MTS

2% Minoxidil Topical Solution

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

5% MTF

5% Minoxidil Topical Foam

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

Total Total of all reporting groups

Baseline Measures
   2% MTS   5% MTF   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   161   322 
Age 
[Units: Participants]
     
<=18 years   1   1   2 
Between 18 and 65 years   134   129   263 
>=65 years   26   31   57 
Gender 
[Units: Participants]
     
Female   161   161   322 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   4   7   11 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   4   5   9 
White   149   141   290 
More than one race   0   0   0 
Unknown or Not Reported   4   6   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Target Area Hair Count (TAHC)   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:   Target Area Hair Count (TAHC)   [ Time Frame: Baseline to Week 12 ]

3.  Other Pre-specified:   Target Area Hair Count (TAHC)   [ Time Frame: Baseline to Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc.
phone: (973) 385-3203


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01145625     History of Changes
Other Study ID Numbers: MINALO3004
2009-018109-29 ( EudraCT Number )
First Submitted: June 15, 2010
First Posted: June 16, 2010
Results First Submitted: March 26, 2014
Results First Posted: April 25, 2014
Last Update Posted: May 22, 2014