Trial Outcomes & Findings for Clinical Trial in Females for Female Pattern Hair Loss (NCT NCT01226459)
NCT ID: NCT01226459
Last Updated: 2014-06-10
Results Overview
Number of hairs in the area being examined as measured by macrophotography.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-06-10
Participant Flow
Participant milestones
| Measure |
Vehicle Foam
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
|
Minoxidil Foam
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 Study
STARTED
|
201
|
203
|
|
Overall Study
COMPLETED
|
180
|
171
|
|
Overall Study
NOT COMPLETED
|
21
|
32
|
Reasons for withdrawal
| Measure |
Vehicle Foam
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
|
Minoxidil Foam
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 Study
Adverse Event
|
2
|
8
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
13
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
Clinical Trial in Females for Female Pattern Hair Loss
Baseline characteristics by cohort
| Measure |
Vehicle Foam
n=201 Participants
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
|
Minoxidil Foam
n=203 Participants
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
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
305 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=93 Participants
|
203 Participants
n=4 Participants
|
404 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
55 participants
n=93 Participants
|
50 participants
n=4 Participants
|
105 participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
140 participants
n=93 Participants
|
145 participants
n=4 Participants
|
285 participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: 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.
Number of hairs in the area being examined as measured by macrophotography.
Outcome measures
| Measure |
Vehicle Foam
n=197 Participants
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
|
Minoxidil Foam
n=200 Participants
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
|
|---|---|---|
|
Target Area Hair Count
Baseline
|
152.7 hairs per centimeter squared
Standard Deviation 59.7
|
158.6 hairs per centimeter squared
Standard Deviation 61.6
|
|
Target Area Hair Count
Week 24
|
162.2 hairs per centimeter squared
Standard Deviation 63.1
|
175.7 hairs per centimeter squared
Standard Deviation 65.1
|
|
Target Area Hair Count
Change from Baseline to Week 24
|
4.0 hairs per centimeter squared
Standard Deviation 16.2
|
13.5 hairs per centimeter squared
Standard Deviation 22.3
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Vehicle Foam
n=183 Participants
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
|
Minoxidil Foam
n=180 Participants
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
|
|---|---|---|
|
Subject Assessment of Scalp Coverage
|
0.06 scores on a scale
Standard Deviation 1.66
|
0.74 scores on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
Number of hairs in the area being examined as measured by macrophotography.
Outcome measures
| Measure |
Vehicle Foam
n=197 Participants
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
|
Minoxidil Foam
n=200 Participants
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
|
|---|---|---|
|
Target Area Hair Count
Baseline
|
152.7 hairs per centimeter squared
Standard Error 59.7
|
158.6 hairs per centimeter squared
Standard Error 61.6
|
|
Target Area Hair Count
Week 12
|
163.3 hairs per centimeter squared
Standard Error 63.2
|
178.1 hairs per centimeter squared
Standard Error 66.4
|
|
Target Area Hair Count
Change from Baseline to Week 12
|
5.4 hairs per centimeter squared
Standard Error 15.3
|
16.4 hairs per centimeter squared
Standard Error 21.5
|
Adverse Events
Vehicle Foam
Serious events: 4 serious events
Other events: 57 other events
Deaths: 0 deaths
Minoxidil Foam
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Foam
n=201 participants at risk
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
|
Minoxidil Foam
n=203 participants at risk
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
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.50%
1/201
|
0.00%
0/203
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/201
|
0.49%
1/203
|
|
Nervous system disorders
Uterine Leiomyoma
|
0.00%
0/201
|
0.49%
1/203
|
|
Cardiac disorders
Atrial Fibrillation
|
0.50%
1/201
|
0.00%
0/203
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/201
|
0.49%
1/203
|
|
Cardiac disorders
Cor Pulmonale Acute
|
0.50%
1/201
|
0.00%
0/203
|
|
General disorders
Asthenia
|
1.00%
2/201
|
0.00%
0/203
|
|
General disorders
Fatigue
|
0.50%
1/201
|
0.00%
0/203
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/201
|
0.49%
1/203
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/201
|
0.49%
1/203
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/201
|
0.49%
1/203
|
|
Nervous system disorders
Memory Impairment
|
0.50%
1/201
|
0.00%
0/203
|
|
Psychiatric disorders
Mental Status Changes
|
0.50%
1/201
|
0.00%
0/203
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.50%
1/201
|
0.00%
0/203
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/201
|
0.49%
1/203
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/201
|
0.49%
1/203
|
Other adverse events
| Measure |
Vehicle Foam
n=201 participants at risk
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
|
Minoxidil Foam
n=203 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.5%
13/201
|
5.4%
11/203
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.0%
8/201
|
2.5%
5/203
|
|
Infections and infestations
Sinusitis
|
2.5%
5/201
|
3.4%
7/203
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/201
|
3.0%
6/203
|
|
Infections and infestations
Urinary Tract Infection
|
0.50%
1/201
|
2.0%
4/203
|
|
Investigations
Weight Increased
|
7.0%
14/201
|
8.4%
17/203
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.00%
2/201
|
2.5%
5/203
|
|
Nervous system disorders
Headache
|
4.0%
8/201
|
3.0%
6/203
|
|
Vascular disorders
Hypertension
|
2.5%
5/201
|
0.99%
2/203
|
Additional Information
Study Director
Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc.
Phone: (973) 385-3203
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER