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5% Minoxidil

Phase 3

Alopecia | Small molecule | Dermatology |Johnson & Johnson|Last Updated: May 22, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment322

FDA Designations

No designations recorded

Clinical trial landscape

5% Minoxidil · 1 trial · 1 indication

Phase 3 1
NCT01145625Clinical Trial in Females With Female Pattern Hair LossAlopecia
COMPLETED322 Analytics
PHASE3COMPLETED
Clinical Trial in Females With Female Pattern Hair Loss
AlopeciaUnlock trial analytics

Study Endpoints

Primary Endpoints

Target Area Hair Count (TAHC)
Baseline to Week 24

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

Secondary Endpoints

Target Area Hair Count (TAHC)
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5% MTFEXPERIMENTAL5% Minoxidil Topical Foam
2% MTSACTIVE_COMPARATOR2% Minoxidil Topical Solution

Interventions

NameTypeDescription
5% MinoxidilDRUGhalf a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
2% MinoxidilDRUGone ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * females, age 18 or older in general good health * exhibits female pattern hair loss * signs and dates an informed consent document * agrees to use an adequate method of birth control; if of childbearing potential * shows a negative urine pregnancy test at Screening Visit * is ...

Countries:United StatesCanadaFranceGermanyUnited Kingdom
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Frequently asked questions about 5% Minoxidil

What is 5% Minoxidil used for?

5% Minoxidil is a topical small molecule used for the treatment of alopecia, specifically female pattern hair loss. It is being developed by Johnson & Johnson and is currently in Phase 3 clinical development for this dermatological condition.

Who makes 5% Minoxidil?

Johnson & Johnson (NYSE: JNJ) is the developer of 5% Minoxidil. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of alopecia in women.

What phase is 5% Minoxidil in?

5% Minoxidil is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 322 female participants with female pattern hair loss.

What clinical trials is 5% Minoxidil in?

5% Minoxidil has one completed Phase 3 clinical trial, NCT01145625, titled 'Clinical Trial in Females With Female Pattern Hair Loss.' The trial enrolled 322 female participants aged 18 years and older with alopecia, conducted in the United States, Canada, France, Germany, and the United Kingdom.

Is 5% Minoxidil the same as minoxidil?

5% Minoxidil is a specific concentration of the active ingredient minoxidil. It is being studied as a treatment for female pattern hair loss, and the 5% formulation is the focus of the ongoing clinical development program.