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Low dose DFD07 once daily

Phase 2

Actinic Keratosis (AK) | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 24, 2019

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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03116698A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment PeriodPHASE2 COMPLETED 240Feb 14, 2017Jul 5, 2018Apr 24, 201920 United States
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Study Endpoints
Primary Endpoints
Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks
16 Weeks

The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)

Secondary Endpoints
Proportion of Subjects With Partial Clearance at Week 16
16 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low dose DFD07 once dailyEXPERIMENTAL -
High dose DFD07 once dailyEXPERIMENTAL -
High dose DFD07 twice dailyEXPERIMENTAL -
Placebo twice dailyPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Low dose DFD07 once dailyDRUGLow dose DFD07 once daily
High dose DFD07 once dailyDRUGHigh dose DFD07 once daily
High dose DFD07 twice dailyDRUGHigh dose DFD07 twice daily
Placebo twice dailyDRUGPlacebo twice daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion: 1. Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian. 2. Subject (or lega...

Countries:United States
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