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pimecrolimus and clobetasol

Phase 2

Lichen Sclerosus | Small molecule | Other |Novartis AG|Last Updated: May 12, 2014

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00393263Clobetasol Versus Pimecrolimus for Vulvar Lichen SclerosusPHASE2 COMPLETED 38Oct 1, 2006Oct 1, 2009May 12, 20141 United States
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Study Endpoints
Primary Endpoints
Change in inflammation
3 months
Secondary Endpoints
Pruritus
3 months
Burning
3 months
Pain
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALpimecrolimus
2ACTIVE_COMPARATORclobetasol
Interventions
NameTypeDescription
pimecrolimus and clobetasolDRUG -
clobetasol 0.05% creamDRUGtwice daily for three months
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female, 18 years or older. * With a diagnosis of biopsy proven active vulvar lichen sclerosus. * Signed written informed consent. * Willingness and ability to comply with the study requirements. * Negative urine pregnancy tests must be documented for all females of childbearin...

Countries:United States
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