Clinical Trial in Females for Female Pattern Hair Loss
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| ClinicalTrials.gov Identifier: NCT01226459 |
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Recruitment Status :
Completed
First Posted : October 22, 2010
Results First Posted : June 3, 2014
Last Update Posted : June 10, 2014
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Sponsor:
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborator:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Androgenetic Alopecia |
| Interventions |
Drug: 5% Minoxidil Topical Foam Drug: Vehicle Topical Foam |
| Enrollment | 404 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Vehicle Foam | Minoxidil Foam |
|---|---|---|
 Arm/Group Description |
Vehicle Topical Foam Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks |
5% Minoxidil Topical Foam 5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks |
| Period Title: Overall Study | ||
| Started | 201 | 203 |
| Completed | 180 | 171 |
| Not Completed | 21 | 32 |
| Reason Not Completed | ||
| Adverse Event | 2 | 8 |
| Protocol Violation | 4 | 3 |
| Withdrawal by Subject | 10 | 13 |
| Lost to Follow-up | 4 | 8 |
| Pregnancy | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Vehicle Foam | Minoxidil Foam | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Vehicle Topical Foam Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks |
5% Minoxidil Topical Foam 5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 201 | 203 | 404 | |
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Baseline Analysis Population Description |
Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 201 participants | 203 participants | 404 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
148 73.6%
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157 77.3%
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305 75.5%
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| >=65 years |
53 26.4%
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46 22.7%
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99 24.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 201 participants | 203 participants | 404 participants | |
| Female |
201 100.0%
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203 100.0%
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404 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 201 participants | 203 participants | 404 participants |
| American Indian or Alaska Native | 3 | 1 | 4 | |
| Asian | 3 | 4 | 7 | |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | |
| Black or African American | 55 | 50 | 105 | |
| White | 140 | 145 | 285 | |
| More than one race | 0 | 0 | 0 | |
| Unknown or Not Reported | 0 | 1 | 1 | |
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[1]
Measure Description: One participant in minoxidil foam group had no information on race and hair loss duration
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Multi-Center Publication will be the first publication to present the results of the Study. Upon such Multi-Center Publication, or the earlier of (a) Sponsor's confirmation that there will be no Multi-Center Publication or presentation, or (b) 12 months after the completion of the entire multi-center study, Institution and Investigator may publish or present Study data and results generated in their performance of the Study in accordance with the terms of this Article.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc. |
| Phone: | (973) 385-3203 |
| Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01226459 |
| Other Study ID Numbers: |
MINALO3005 2010-019881-96 ( EudraCT Number ) |
| First Submitted: | October 20, 2010 |
| First Posted: | October 22, 2010 |
| Results First Submitted: | March 26, 2014 |
| Results First Posted: | June 3, 2014 |
| Last Update Posted: | June 10, 2014 |