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Imiquimod

Phase 3

Carcinoma, Basal Cell | Small molecule | Oncology |Viatris Inc.|Last Updated: Feb 22, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00189280Aldara for the Treatment of Large and/or Multiple sBCCPHASE3 COMPLETED 111May 1, 2003Oct 1, 2007Feb 22, 20221 France
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Study Endpoints
Primary Endpoints
Clinical clearance of sBCC
12 or 16 weeks after treatment
Secondary Endpoints
Reduction in size of tumour
12 or 16 weeks after treatment
Rate of clearance, Cosmetic outcome
12 or 16 weeks after treatment
Sustained clearance rate over 3 year follow-up
3 years after treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
imiqimod 5% creamEXPERIMENTAL -
Interventions
NameTypeDescription
ImiquimodDRUGcream 5%, 5 days out of seven, for 6 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * One or more sBCC on torso, neck or face * Total surface area \<= 40 sq cm Exclusion Criteria: * Pregnancy or women who are breastfeeding * Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors * Metatypical, adnexal,...

Countries:France
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