Recent Updates
Recently added Catalysts

imiquimod

Phase 3

Actinic Keratoses | Small molecule | Other |3M Company|Last Updated: May 9, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00175643Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic KeratosesPHASE3 COMPLETED 20 — — Feb 1, 2005Nov 1, 2005May 9, 20061 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Complete clearance rate - defined as the proportion of subjects at the end of cycle 1 or cycle 2 with no (zero) clinically visible AK lesions in the treatment area.
Secondary Endpoints
Partial clearance rate - defined as the proportion of subjects at the end of cycle 2 with at least 75% reduction from the number of AK lesions counted at baseline in the treatment area
Sustained clearance rate at week 8 post-treatment.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
imiquimodDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * At least 18 years of age. * Have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic, non-hypertrophic AK lesions located within a contiguous 25 cm2 treatment area (balding scalp or face, but not both). * Free of any significant findings (e.g. tattoos) in the po...

Countries:Canada
Unlock Eligibility Criteria