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Clinical Trial in Females With Female Pattern Hair Loss

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ClinicalTrials.gov Identifier: NCT01145625
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : April 25, 2014
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )

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
Enrollment 322
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2% MTS 5% MTF
Hide Arm/Group Description

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% 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

Period Title: Overall Study
Started 161 161
Completed 137 130
Not Completed 24 31
Reason Not Completed
Lost to Follow-up             8             9
Adverse Event             6             4
Protocol Violation             3             1
Withdrawal by Subject             7             16
Pregnancy             0             1
Arm/Group Title 2% MTS 5% MTF Total
Hide Arm/Group Description

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% 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 of all reporting groups
Overall Number of Baseline Participants 161 161 322
Hide Baseline Analysis Population Description
Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 322 participants
<=18 years
1
   0.6%
1
   0.6%
2
   0.6%
Between 18 and 65 years
134
  83.2%
129
  80.1%
263
  81.7%
>=65 years
26
  16.1%
31
  19.3%
57
  17.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 322 participants
Female
161
 100.0%
161
 100.0%
322
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 161 participants 322 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
1
   0.3%
Asian
4
   2.5%
7
   4.3%
11
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.3%
Black or African American
4
   2.5%
5
   3.1%
9
   2.8%
White
149
  92.5%
141
  87.6%
290
  90.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   2.5%
6
   3.7%
10
   3.1%
1.Primary Outcome
Title Target Area Hair Count (TAHC)
Hide Description Number of hairs in the area being examined as measured by macrophotography.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
Arm/Group Title 2% MTS 5% MTF
Hide Arm/Group Description:

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% 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

Overall Number of Participants Analyzed 161 161
Mean (Standard Deviation)
Unit of Measure: hairs per centimeter squared
Baseline 167.3  (55.0) 169.7  (58.6)
Week 24 192.8  (57.0) 194.4  (64.7)
Change from Baseline to Week 24 23.8  (24.7) 23.7  (22.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% MTS, 5% MTF
Comments Statistical analysis is for the change from baseline to week 24 data.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.
Statistical Test of Hypothesis P-Value 0.9170
Comments [Not Specified]
Method ANCOVA
Comments P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-6.0 to 5.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Target Area Hair Count (TAHC)
Hide Description Number of hairs in the area being examined as measured by macrophotography
Time Frame Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
Arm/Group Title 2% MTS 5% MTF
Hide Arm/Group Description:

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% 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

Overall Number of Participants Analyzed 161 161
Mean (Standard Deviation)
Unit of Measure: hairs per centimeter squared
Baseline 167.3  (55.0) 169.7  (58.6)
Week 12 190.7  (56.9) 191.8  (62.6)
Change from Baseline to Week 12 22.5  (22.8) 24.9  (26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% MTS, 5% MTF
Comments Statistical analysis is for the change from baseline to week 12 data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.4158
Comments [Not Specified]
Method ANCOVA
Comments P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-3.4 to 8.2
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Target Area Hair Count (TAHC)
Hide Description Number of hairs in the area being examined as measured by macrophotography.
Time Frame Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
Arm/Group Title 2% MTS 5% MTF
Hide Arm/Group Description:

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% 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

Overall Number of Participants Analyzed 161 161
Mean (Standard Deviation)
Unit of Measure: hairs per centimeter squared
Baseline 167.3  (55.0) 169.7  (58.6)
Week 52 189.1  (55.8) 186.9  (61.1)
Change from Baseline to Week 52 19.4  (21.5) 18.1  (23.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2% MTS, 5% MTF
Comments Statistical analysis is for the change from baseline to week 52 data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5980
Comments [Not Specified]
Method ANCOVA
Comments P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-7.1 to 4.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2% MTS 5% MTF
Hide Arm/Group Description

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% 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

All-Cause Mortality
2% MTS 5% MTF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2% MTS 5% MTF
Affected / at Risk (%) Affected / at Risk (%)
Total   8/161 (4.97%)   2/161 (1.24%) 
Cardiac disorders     
Angina Pectoris  1  1/161 (0.62%)  0/161 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  1/161 (0.62%)  0/161 (0.00%) 
Hepatobiliary disorders     
Bile Duct Stone  1  1/161 (0.62%)  0/161 (0.00%) 
Infections and infestations     
Anal Abscess  1  1/161 (0.62%)  0/161 (0.00%) 
Influenza  1  1/161 (0.62%)  0/161 (0.00%) 
Injury, poisoning and procedural complications     
Wrist Fracture  1  0/161 (0.00%)  1/161 (0.62%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic Neoplasm  1  1/161 (0.62%)  0/161 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/161 (0.00%)  1/161 (0.62%) 
Reproductive system and breast disorders     
Menometrorrhagia  1  1/161 (0.62%)  0/161 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/161 (0.62%)  0/161 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
2% MTS 5% MTF
Affected / at Risk (%) Affected / at Risk (%)
Total   118/161 (73.29%)   109/161 (67.70%) 
Gastrointestinal disorders     
Diarrhoea  1  2/161 (1.24%)  5/161 (3.11%) 
Toothache  1  4/161 (2.48%)  1/161 (0.62%) 
Abdominal pain upper  1  4/161 (2.48%)  0/161 (0.00%) 
General disorders     
Influenza like illness  1  3/161 (1.86%)  4/161 (2.48%) 
Infections and infestations     
Nasopharyngitis  1  22/161 (13.66%)  23/161 (14.29%) 
Upper respiratory tract infection  1  8/161 (4.97%)  16/161 (9.94%) 
Sinusitis  1  12/161 (7.45%)  10/161 (6.21%) 
Urinary tract infection  1  3/161 (1.86%)  8/161 (4.97%) 
Bronchitis  1  2/161 (1.24%)  8/161 (4.97%) 
Cystitis  1  4/161 (2.48%)  4/161 (2.48%) 
Gastroenteritis  1  4/161 (2.48%)  2/161 (1.24%) 
Injury, poisoning and procedural complications     
Procedural pain  1  6/161 (3.73%)  4/161 (2.48%) 
Fall  1  3/161 (1.86%)  4/161 (2.48%) 
Investigations     
Weight increased  1  14/161 (8.70%)  20/161 (12.42%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  5/161 (3.11%)  7/161 (4.35%) 
Arthralgia  1  4/161 (2.48%)  2/161 (1.24%) 
Nervous system disorders     
Headache  1  16/161 (9.94%)  9/161 (5.59%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/161 (3.11%)  4/161 (2.48%) 
Oropharyngeal pain  1  0/161 (0.00%)  5/161 (3.11%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  4/161 (2.48%)  4/161 (2.48%) 
Pruritus  1  4/161 (2.48%)  4/161 (2.48%) 
Vascular disorders     
Hypertension  1  3/161 (1.86%)  5/161 (3.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
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: 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