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Minoxidil

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment422
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00151515A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair LossPHASE3 COMPLETED 352Oct 1, 2003Jul 1, 2004Sep 30, 201615 United States
NCT01319370Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic AlopeciaPHASE2 COMPLETED 70Nov 1, 2010Mar 1, 2013Nov 7, 20131 Germany
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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 — 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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