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DFD-07

Phase 2

Actinic Keratosis | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Mar 17, 2020

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 Enrollment111
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02654717Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and ScalpPHASE2 COMPLETED 111Nov 1, 2015Aug 1, 2016Mar 17, 20203 Germany
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Study Endpoints
Primary Endpoints
Percent of Patients With Complete Clearance of Lesions
8 weeks

Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DFD-07 creamEXPERIMENTALDFD-07 cream applied twice daily
Placebo creamPLACEBO_COMPARATORPlacebo cream applied twice daily
Interventions
NameTypeDescription
DFD-07 CreamDRUG -
Placebo CreamDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: To be eligible for the study, the patients have to fulfil all of the following criteria at Visit 1: 1. Written informed consent has been signed and dated prior to any study related procedure or initiation of a wash out period 2. Skin type I, II or III according to Fitzpatrick 3...

Countries:Germany
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