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5% Minoxidil Foam

Phase 3

Androgenetic Alopecia | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Jun 10, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment404

FDA Designations

No designations recorded

Clinical trial landscape

5% Minoxidil Foam · 1 trial · 1 indication

Phase 3 1
NCT01226459Clinical Trial in Females for Female Pattern Hair LossAndrogenetic Alopecia
COMPLETED404 Analytics
PHASE3COMPLETED
Clinical Trial in Females for Female Pattern Hair Loss
Androgenetic AlopeciaUnlock trial analytics

Study Endpoints

Primary Endpoints

Target Area Hair Count
Baseline to Week 24

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

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 Endpoints

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

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Minoxidil FoamEXPERIMENTAL5% Minoxidil Topical Foam
Vehicle FoamPLACEBO_COMPARATORVehicle Topical Foam

Interventions

NameTypeDescription
5% Minoxidil Topical FoamDRUGDosage 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
Vehicle Topical FoamDRUGDosage 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
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites17

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 StatesFranceGermanyUnited Kingdom
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Frequently asked questions about 5% Minoxidil Foam

What is 5% Minoxidil Foam used for?

5% Minoxidil Foam is used for androgenetic alopecia, a common form of hair loss. It is a topical foam formulation of minoxidil, a small molecule, applied to the scalp to promote hair regrowth. The drug is being developed by Johnson & Johnson for this dermatological condition.

Who makes 5% Minoxidil Foam?

Johnson & Johnson (NYSE: JNJ) is the developer of 5% Minoxidil Foam. The company is conducting clinical research on this topical foam for the treatment of androgenetic alopecia, also known as pattern hair loss.

What phase is 5% Minoxidil Foam in?

5% Minoxidil Foam is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities based on the available data.

What clinical trials is 5% Minoxidil Foam in?

5% Minoxidil Foam has one completed Phase 3 trial, NCT01226459, titled 'Clinical Trial in Females for Female Pattern Hair Loss.' The study enrolled 404 female participants with androgenetic alopecia across the United States, France, Germany, and the United Kingdom.

Is 5% Minoxidil Foam the same as minoxidil?

5% Minoxidil Foam is a specific formulation of minoxidil, a small molecule used to treat hair loss. The foam is designed for topical application to the scalp. It is being studied for androgenetic alopecia, and the completed trial focused on female pattern hair loss.