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Minocycline Foam FXFM244

Phase 2

Acne Vulgaris | Small molecule | Dermatology |VYNE Therapeutics Inc.|Last Updated: Aug 15, 2013

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01362010Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris PatientsPHASE2 COMPLETED 150Jan 1, 2012Jul 1, 2013Aug 15, 20133 Israel
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Study Endpoints
Primary Endpoints
Decrease in lesions count
12 weeks

The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline

Investigator global assessment
12 weeks

Physician's Global Improvement Assessment

Secondary Endpoints
% change in lesions count
12 weeks
Global assessment of improvement by photographs
12 weeks
Subject-reported outcome assessment
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Topical Minocycline Foam FXFM244 - 4%EXPERIMENTALActive ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening.
Topical Minocycline Foam FXFM244 - 1%EXPERIMENTALActive ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening.
Placebo foamPLACEBO_COMPARATORActive ingredient: None Route: Topical Dosage schedule: Once daily, evening
Interventions
NameTypeDescription
Topical Minocycline Foam FXFM244DRUGTopically applied once a day.
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Eligibility Criteria
Age Range12 Years — 25 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * A clinical diagnosis of Acne Vulgaris with facial involvement. * A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules). * A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones). * N...

Countries:Israel
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