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Pimecrolimus

Phase 3

Perioral Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: Jan 17, 2008

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 Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232115Pimecrolimus Cream 1% in Adult Patients With Perioral DermatitisPHASE3 COMPLETED 124Sep 1, 2005Jul 1, 2006Jan 17, 20081 Germany
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Study Endpoints
Primary Endpoints
Reduction of the Perioral Dermatitis Severity Index
Secondary Endpoints
Time to disease recurrence
Response rates
Patient's quality of life assessment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPimecrolimus
2PLACEBO_COMPARATORVehicle
Interventions
NameTypeDescription
PimecrolimusDRUGPimecrolimus cream 1 %
PlaceboDRUGVehicle cream (placebo)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region) * minimum severity score (PODSI) ≥ 4 * age 18 and older Exclusion Criteria: * Ongoing use of the foll...

Countries:Germany
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