Trial · NCT01226459

Clinical Trial in Females for Female Pattern Hair Loss

NCT01226459, Phase 3, Completed, Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.; results first posted 2014-06-03

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. Clinical Trial in Females for Female Pattern Hair Loss. Trials, record NCT01226459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01226459

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial in Females for Female Pattern Hair Loss
NCT number: NCT01226459
Status: Completed
Phases: Phase 3
Enrollment: 404 participants, actual
Lead sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Conditions: Androgenetic Alopecia
Interventions: 5% Minoxidil Topical Foam, Vehicle Topical Foam
First posted: 2010-10-22
Last updated: 2014-06-10
Other registries' IDs: eudract:2010-019881-96
Results first posted: 2014-06-03

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Target Area Hair Count	Baseline to Week 24	Number of hairs in the area being examined as measured by macrophotography.
Primary	Subject Assessment of Scalp Coverage	Week 24	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.
Secondary	Target Area Hair Count	Baseline to Week 12	Number of hairs in the area being examined as measured by macrophotography.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Target Area Hair Count	Baseline to Week 24	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.	hairs per centimeter squared	MEAN
SECONDARY	Target Area Hair Count	Baseline to Week 12	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.	hairs per centimeter squared	MEAN
PRIMARY	Subject Assessment of Scalp Coverage	Week 24	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.	scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Target Area Hair Count	Vehicle Foam	Baseline	152.7	Standard Deviation 59.7	hairs per centimeter squared
Target Area Hair Count	Minoxidil Foam	Baseline	158.6	Standard Deviation 61.6	hairs per centimeter squared
Target Area Hair Count	Vehicle Foam	Week 24	162.2	Standard Deviation 63.1	hairs per centimeter squared
Target Area Hair Count	Minoxidil Foam	Week 24	175.7	Standard Deviation 65.1	hairs per centimeter squared
Target Area Hair Count	Vehicle Foam	Change from Baseline to Week 24	4.0	Standard Deviation 16.2	hairs per centimeter squared
Target Area Hair Count	Minoxidil Foam	Change from Baseline to Week 24	13.5	Standard Deviation 22.3	hairs per centimeter squared
Target Area Hair Count	Vehicle Foam	Baseline	152.7	Standard Error 59.7	hairs per centimeter squared
Target Area Hair Count	Minoxidil Foam	Baseline	158.6	Standard Error 61.6	hairs per centimeter squared
Target Area Hair Count	Vehicle Foam	Week 12	163.3	Standard Error 63.2	hairs per centimeter squared
Target Area Hair Count	Minoxidil Foam	Week 12	178.1	Standard Error 66.4	hairs per centimeter squared

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vehicle Foam	201
Overall Study	STARTED	Minoxidil Foam	203
Overall Study	COMPLETED	Vehicle Foam	180
Overall Study	COMPLETED	Minoxidil Foam	171
Overall Study	NOT COMPLETED	Vehicle Foam	21
Overall Study	NOT COMPLETED	Minoxidil Foam	32

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Vehicle Foam	13	201
other	Nasopharyngitis	Infections and infestations	Minoxidil Foam	11	203
other	Upper Respiratory Tract Infection	Infections and infestations	Vehicle Foam	8	201
other	Upper Respiratory Tract Infection	Infections and infestations	Minoxidil Foam	5	203
other	Sinusitis	Infections and infestations	Vehicle Foam	5	201
other	Sinusitis	Infections and infestations	Minoxidil Foam	7	203
other	Gastroenteritis	Infections and infestations	Vehicle Foam	1	201
other	Gastroenteritis	Infections and infestations	Minoxidil Foam	6	203
other	Urinary Tract Infection	Infections and infestations	Vehicle Foam	1	201
other	Urinary Tract Infection	Infections and infestations	Minoxidil Foam	4	203

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vehicle Foam
Total, all-cause mortality	Minoxidil Foam
Total, other adverse events	Vehicle Foam	57	201
Total, other adverse events	Minoxidil Foam	63	203
Total, serious adverse events	Vehicle Foam	4	201
Total, serious adverse events	Minoxidil Foam	6	203

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Minoxidil Foam vs Vehicle Foam: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01226459

GET https://conductscience.org/api/trials/v1/NCT01226459/events?page=2

API reference For AI assistants