Trial Outcomes & Findings for Clinical Trial in Females With Female Pattern Hair Loss (NCT NCT01145625)

NCT ID: NCT01145625

Last Updated: 2014-05-22

Results Overview

Number of hairs in the area being examined as measured by macrophotography.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 322 participants
• Primary outcome timeframe: Baseline to Week 24
• Results posted on: 2014-05-22

Participant Flow

Participant milestones

Measure	2% MTS 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% MTF 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 Study STARTED	161	161
Overall Study COMPLETED	137	130
Overall Study NOT COMPLETED	24	31

Reasons for withdrawal

Measure	2% MTS 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% MTF 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 Study Lost to Follow-up	8	9
Overall Study Adverse Event	6	4
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	7	16
Overall Study Pregnancy	0	1

Baseline Characteristics

Clinical Trial in Females With Female Pattern Hair Loss

Baseline characteristics by cohort

Measure	2% MTS n=161 Participants 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% MTF n=161 Participants 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 n=322 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=5 Participants	129 Participants n=7 Participants	263 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	161 Participants n=7 Participants	322 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants	141 Participants n=7 Participants	290 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.

Number of hairs in the area being examined as measured by macrophotography.

Outcome measures

Measure	2% MTS n=161 Participants 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% MTF n=161 Participants 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
Target Area Hair Count (TAHC) Week 24	192.8 hairs per centimeter squared Standard Deviation 57.0	194.4 hairs per centimeter squared Standard Deviation 64.7
Target Area Hair Count (TAHC) Baseline	167.3 hairs per centimeter squared Standard Deviation 55.0	169.7 hairs per centimeter squared Standard Deviation 58.6
Target Area Hair Count (TAHC) Change from Baseline to Week 24	23.8 hairs per centimeter squared Standard Deviation 24.7	23.7 hairs per centimeter squared Standard Deviation 22.9

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.

Number of hairs in the area being examined as measured by macrophotography

Outcome measures

Measure	2% MTS n=161 Participants 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% MTF n=161 Participants 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
Target Area Hair Count (TAHC) Baseline	167.3 hairs per centimeter squared Standard Deviation 55.0	169.7 hairs per centimeter squared Standard Deviation 58.6
Target Area Hair Count (TAHC) Week 12	190.7 hairs per centimeter squared Standard Deviation 56.9	191.8 hairs per centimeter squared Standard Deviation 62.6
Target Area Hair Count (TAHC) Change from Baseline to Week 12	22.5 hairs per centimeter squared Standard Deviation 22.8	24.9 hairs per centimeter squared Standard Deviation 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 52

Population: Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.

Number of hairs in the area being examined as measured by macrophotography.

Outcome measures

Measure	2% MTS n=161 Participants 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% MTF n=161 Participants 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
Target Area Hair Count (TAHC) Baseline	167.3 hairs per centimeter squared Standard Deviation 55.0	169.7 hairs per centimeter squared Standard Deviation 58.6
Target Area Hair Count (TAHC) Week 52	189.1 hairs per centimeter squared Standard Deviation 55.8	186.9 hairs per centimeter squared Standard Deviation 61.1
Target Area Hair Count (TAHC) Change from Baseline to Week 52	19.4 hairs per centimeter squared Standard Deviation 21.5	18.1 hairs per centimeter squared Standard Deviation 23.4

Adverse Events

2% MTS

Serious events: 8 serious events

Other events: 118 other events

Deaths: 0 deaths

5% MTF

Serious events: 2 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Measure	2% MTS n=161 participants at risk 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% MTF n=161 participants at risk 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
Infections and infestations Anal Abscess	0.62% 1/161	0.00% 0/161
Infections and infestations Influenza	0.62% 1/161	0.00% 0/161
Cardiac disorders Angina Pectoris	0.62% 1/161	0.00% 0/161
Gastrointestinal disorders Abdominal Pain	0.62% 1/161	0.00% 0/161
Hepatobiliary disorders Bile Duct Stone	0.62% 1/161	0.00% 0/161
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/161	0.62% 1/161
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.62% 1/161	0.00% 0/161
Psychiatric disorders Anxiety	0.00% 0/161	0.62% 1/161
Reproductive system and breast disorders Menometrorrhagia	0.62% 1/161	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Asthma	0.62% 1/161	0.00% 0/161

Other adverse events

Measure	2% MTS n=161 participants at risk 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% MTF n=161 participants at risk 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
Infections and infestations Nasopharyngitis	13.7% 22/161	14.3% 23/161
Infections and infestations Upper respiratory tract infection	5.0% 8/161	9.9% 16/161
Infections and infestations Sinusitis	7.5% 12/161	6.2% 10/161
Infections and infestations Urinary tract infection	1.9% 3/161	5.0% 8/161
Infections and infestations Bronchitis	1.2% 2/161	5.0% 8/161
Infections and infestations Cystitis	2.5% 4/161	2.5% 4/161
Infections and infestations Gastroenteritis	2.5% 4/161	1.2% 2/161
Skin and subcutaneous tissue disorders Alopecia	2.5% 4/161	2.5% 4/161
Skin and subcutaneous tissue disorders Pruritus	2.5% 4/161	2.5% 4/161
Injury, poisoning and procedural complications Procedural pain	3.7% 6/161	2.5% 4/161
Injury, poisoning and procedural complications Fall	1.9% 3/161	2.5% 4/161
Investigations Weight increased	8.7% 14/161	12.4% 20/161
Nervous system disorders Headache	9.9% 16/161	5.6% 9/161
Musculoskeletal and connective tissue disorders Back pain	3.1% 5/161	4.3% 7/161
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 4/161	1.2% 2/161
Gastrointestinal disorders Diarrhoea	1.2% 2/161	3.1% 5/161
Gastrointestinal disorders Toothache	2.5% 4/161	0.62% 1/161
Gastrointestinal disorders Abdominal pain upper	2.5% 4/161	0.00% 0/161
Respiratory, thoracic and mediastinal disorders Cough	3.1% 5/161	2.5% 4/161
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/161	3.1% 5/161
General disorders Influenza like illness	1.9% 3/161	2.5% 4/161
Vascular disorders Hypertension	1.9% 3/161	3.1% 5/161

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