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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018109-29 | EudraCT Number |
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This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.
This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).
This trial will determine if the benefit of using either study product outweighs the risks.
This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.
This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), using objective efficacy measures and safety assessments.
Study centers will screen a sufficient number of participants so that a minimum of 300 female participants with FPHL will be enrolled, to ensure 270 to complete. There will be at least 16 participants enrolled per center at multiple centers located across the US and globally. Approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% MTF or 2% MTS, for 52 weeks for efficacy and safety evaluations.
Participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. The signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment.
During the trial following enrollment at Baseline, participants will return to the study site at regular intervals for safety assessments, adverse events monitoring, and compliance assessments. At the Week 12, 24, and Week 52 visits TAHC will be evaluated for efficacy analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% MTF | Experimental | 5% Minoxidil Topical Foam |
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| 2% MTS | Active Comparator | 2% Minoxidil Topical Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Minoxidil | Drug | half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography. | Baseline to Week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Kendall, MA | Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27391640 | Derived | Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 2% Minoxidil | Drug | one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks |
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| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| NW Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center, P.C. | Portland | Oregon | 97223 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| The Skin Care Centre | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Centre de Santé Sabouraud | Paris | Île-de-France Region | 75010 | France |
| Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science | Berlin | 10117 | Germany |
| Royal Hallamshire Hospital | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography. | Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. | Posted | Mean | Standard Deviation | hairs per centimeter squared | Baseline to Week 24 |
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| Secondary | Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography | Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. | Posted | Mean | Standard Deviation | hairs per centimeter squared | Baseline to Week 12 |
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| Other Pre-specified | Target Area Hair Count (TAHC) | Number of hairs in the area being examined as measured by macrophotography. | Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. | Posted | Mean | Standard Deviation | hairs per centimeter squared | Baseline to Week 52 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 8 | 161 | 118 | 161 | ||
| EG001 | 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 | 2 | 161 | 109 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Johnson & Johnson Healthcare Products Division of MCNEIL-PPC, Inc. | (973) 385-3203 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change from Baseline to Week 24 |
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