Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial in Females for Female Pattern Hair Loss

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.
ClinicalTrials.gov Identifier: NCT01226459
Recruitment Status : Completed
First Posted : October 22, 2010
Results First Posted : June 3, 2014
Last Update Posted : June 10, 2014
Sponsor:
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. )

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Foam Minoxidil Foam
Hide 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
Arm/Group Title Vehicle Foam Minoxidil Foam Total
Hide 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
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 201 participants 203 participants 404 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
  73.6%
157
  77.3%
305
  75.5%
>=65 years
53
  26.4%
46
  22.7%
99
  24.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 203 participants 404 participants
Female
201
 100.0%
203
 100.0%
404
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
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
[1]
Measure Description: One participant in minoxidil foam group had no information on race and hair loss duration
1.Primary Outcome
Title Target Area Hair Count
Hide Description Number of hairs in the area being examined as measured by macrophotography.
Time Frame Baseline to Week 24
Hide 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. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.
Arm/Group Title Vehicle Foam Minoxidil Foam
Hide 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

Overall Number of Participants Analyzed 197 200
Mean (Standard Deviation)
Unit of Measure: hairs per centimeter squared
Baseline 152.7  (59.7) 158.6  (61.6)
Week 24 162.2  (63.1) 175.7  (65.1)
Change from Baseline to Week 24 4.0  (16.2) 13.5  (22.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Foam, Minoxidil Foam
Comments Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value is 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 9.1
Confidence Interval (2-Sided) 95%
5.0 to 13.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Subject Assessment of Scalp Coverage
Hide Description Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.
Time Frame Week 24
Hide 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. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.
Arm/Group Title Vehicle Foam Minoxidil Foam
Hide 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

Overall Number of Participants Analyzed 183 180
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.06  (1.66) 0.74  (1.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Foam, Minoxidil Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.35 to 1.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Target Area Hair Count
Hide Description Number of hairs in the area being examined as measured by macrophotography.
Time Frame Baseline to Week 12
Hide 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. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.
Arm/Group Title Vehicle Foam Minoxidil Foam
Hide 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

Overall Number of Participants Analyzed 197 200
Mean (Standard Error)
Unit of Measure: hairs per centimeter squared
Baseline 152.7  (59.7) 158.6  (61.6)
Week 12 163.3  (63.2) 178.1  (66.4)
Change from Baseline to Week 12 5.4  (15.3) 16.4  (21.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Foam, Minoxidil Foam
Comments Statistical analysis is of the change from baseline to week 12 data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments P-value is 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 10.8
Confidence Interval (2-Sided) 95%
7.0 to 14.7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Foam Minoxidil Foam
Hide 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

All-Cause Mortality
Vehicle Foam Minoxidil Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Foam Minoxidil Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   4/201 (1.99%)   6/203 (2.96%) 
Cardiac disorders     
Atrial Fibrillation  1  1/201 (0.50%)  0/203 (0.00%) 
Cardiovascular Disorder  1 [1]  0/201 (0.00%)  1/203 (0.49%) 
Cor Pulmonale Acute  1  1/201 (0.50%)  0/203 (0.00%) 
Gastrointestinal disorders     
Gastritis  1  0/201 (0.00%)  1/203 (0.49%) 
General disorders     
Asthenia  1  2/201 (1.00%)  0/203 (0.00%) 
Fatigue  1  1/201 (0.50%)  0/203 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1 [2]  0/201 (0.00%)  1/203 (0.49%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/201 (0.00%)  1/203 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian Cancer  1  1/201 (0.50%)  0/203 (0.00%) 
Ovarian Neoplasm  1  0/201 (0.00%)  1/203 (0.49%) 
Nervous system disorders     
Uterine Leiomyoma  1  0/201 (0.00%)  1/203 (0.49%) 
Memory Impairment  1  1/201 (0.50%)  0/203 (0.00%) 
Psychiatric disorders     
Mental Status Changes  1  1/201 (0.50%)  0/203 (0.00%) 
Post-Traumatic Stress Disorder  1  1/201 (0.50%)  0/203 (0.00%) 
Renal and urinary disorders     
Renal Failure  1 [3]  0/201 (0.00%)  1/203 (0.49%) 
Vascular disorders     
Hypertensive Crisis  1  0/201 (0.00%)  1/203 (0.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
Death (1 participant died from cardiovascular disease)
[2]
Death (1 participant died from both renal failure and dehydration). Note that this is the same participant that died from renal failure.
[3]
Death (1 participant died from both renal failure and dehydration). Note that this is the same participant who died from dehydration.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
Vehicle Foam Minoxidil Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   57/201 (28.36%)   63/203 (31.03%) 
Infections and infestations     
Nasopharyngitis  1  13/201 (6.47%)  11/203 (5.42%) 
Upper Respiratory Tract Infection  1  8/201 (3.98%)  5/203 (2.46%) 
Sinusitis  1  5/201 (2.49%)  7/203 (3.45%) 
Gastroenteritis  1  1/201 (0.50%)  6/203 (2.96%) 
Urinary Tract Infection  1  1/201 (0.50%)  4/203 (1.97%) 
Investigations     
Weight Increased  1  14/201 (6.97%)  17/203 (8.37%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  2/201 (1.00%)  5/203 (2.46%) 
Nervous system disorders     
Headache  1  8/201 (3.98%)  6/203 (2.96%) 
Vascular disorders     
Hypertension  1  5/201 (2.49%)  2/203 (0.99%) 
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: NCT01226459     History of Changes
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