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Aldara

Phase 3

Actinic Keratosis | Small molecule | Other |Viatris Inc.|Last Updated: Feb 7, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00294320Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis LesionsPHASE3 COMPLETED 12Feb 1, 2006Jan 1, 2007Feb 7, 20221 France
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Study Endpoints
Primary Endpoints
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
8 weeks after the end of treatment
Secondary Endpoints
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
8 weeks after the end of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL250mg of Imiquimod cream application once daily 3 times per week.
2PLACEBO_COMPARATOR250mg vehicle cream for application once daily 3 times per week.
Interventions
NameTypeDescription
Aldara (Imiquimod)DRUG250mg of Imiquimod cream for application once daily 3 times per week.
Vehicle creamOTHER250mg vehicle cream for application once daily 3 times per week.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions * Free of any significant findings (e.g tattoos) in the potential application site area. * Willing to discontinue sun-tanning and use of sunbed/sun parlour use * Willing to stop use...

Countries:France
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