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Minoxidil

Phase 3

Androgenetic Alopecia | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Sep 30, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment422

FDA Designations

No designations recorded

Clinical trial landscape

Minoxidil · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00151515A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair LossAndrogenetic Alopecia
COMPLETED352 Analytics
PHASE3COMPLETED
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
Androgenetic AlopeciaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings
Baseline to 16 Weeks
Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks
Baseline, week 8, week 16, week 24, week 52, week 76, week 104

Secondary Endpoints

Visual assessment of local dermatitis
Each visit, Baseline through Week 16
Vital Signs
Each visit, Baseline through Week 16
Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs
Baseline vs Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTopical 5% minoxidil foam formulation used twice daily
vehicle of 5% Minoxidl topical foamPLACEBO_COMPARATORvehicel foam in twice daily application in temple and vertex region
5% Minoxidil topical foamACTIVE_COMPARATOR5% Minoxidil topical in twice daily application in temple and vertex region

Interventions

NameTypeDescription
minoxidilDRUGTopical 5% minoxidil foam, BID, for sixteen weeks
vehicle of 5% Minoxidil topical foamDRUG1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
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Eligibility Criteria

Age Range15 Years to 49 Years
SexMALE
Healthy VolunteersYes
Study Sites15

Inclusion Criteria: * presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale * Male sex, age 15 to 49, good health * Willingness to have a dot tattoo placed in the target area of the scalp during the study * Willingness to maintain normal shampooing habit...

Countries:United StatesGermany
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Frequently asked questions about Minoxidil

What is Minoxidil used for in androgenetic alopecia?

Minoxidil is used for the treatment of androgenetic alopecia, a common form of hair loss. It is a small molecule developed by Johnson & Johnson (JNJ) and is being studied in clinical trials for this condition. The drug is applied topically as a foam and is intended to promote hair growth in affected individuals.

What does Minoxidil target?

Minoxidil targets the hair follicles to stimulate hair growth. As a small molecule, it works by promoting blood flow to the scalp and increasing the size of hair follicles, which helps counteract the effects of androgenetic alopecia. This mechanism is being evaluated in clinical trials for its effectiveness and safety.

Who makes Minoxidil?

Minoxidil is developed by Johnson & Johnson, a pharmaceutical company traded under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's effectiveness and safety for treating androgenetic alopecia. Johnson & Johnson is responsible for the development and potential commercialization of this treatment.

What phase is Minoxidil in?

Minoxidil is in Phase 3 clinical development for androgenetic alopecia. It has completed two clinical trials, including a Phase 3 study with 352 participants and a Phase 2 study with 70 participants. The drug is investigational and not yet approved, as it is still undergoing clinical evaluation.

What clinical trials is Minoxidil in?

Minoxidil has been studied in two completed clinical trials. NCT00151515 is a Phase 3 study evaluating the effectiveness and safety of 5 percent Minoxidil foam in male pattern hair loss, with 352 participants in the United States. NCT01319370 is a Phase 2 study comparing Minoxidil foam to placebo foam for androgenetic alopecia, with 70 participants in Germany.

Is Minoxidil the same as other hair loss treatments?

Minoxidil is a distinct treatment for androgenetic alopecia and is not the same as other hair loss medications. It is a small molecule developed by Johnson & Johnson and is being evaluated in clinical trials. Its mechanism of action and formulation as a foam differentiate it from other available treatments for hair loss.