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ACT01

Phase 2

Actinic Keratosis | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 22, 2016

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02126670ACT01 in Combination With Comp01-04 in Patients With Actinic KeratosisPHASE2 COMPLETED 100Apr 1, 2014Sep 1, 2014Feb 22, 20164 United States
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Study Endpoints
Primary Endpoints
Treatment Success at End of Study Visit
up to Day 57

Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Secondary Endpoints
Irritation Score
up to Day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACT01 plus Comp01PLACEBO_COMPARATORACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01 plus Comp02ACTIVE_COMPARATORACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01 plus Comp03ACTIVE_COMPARATORACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01 plus Comp04OTHERACT01 Cream in combination with Comp04 Cream, once daily, 29 days
Interventions
NameTypeDescription
ACT01DRUG -
Comp01DRUG -
Comp02DRUG -
Comp03DRUG -
Comp04DRUG -
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Eligibility Criteria
Age Range30 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter. 2. Age 30-85 years, inclusive. 3. Good general health...

Countries:United States
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