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Permethrin

Phase 3

Scabies | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 14, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02572986A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of ScabiesPHASE3 COMPLETED 250Sep 1, 2015Aug 1, 2016Oct 14, 201613 United States, El Salvador +1
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Study Endpoints
Primary Endpoints
Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies
Day 28
Secondary Endpoints
The proportion of patients with no itch persistence
Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Permethrin cream 5%EXPERIMENTALManufactured by Dr. Reddy's Laboratories, Ltd
Elimite™ Cream (permethrin) 5%ACTIVE_COMPARATORManufactured by Prestium Pharma, Inc
Interventions
NameTypeDescription
PermethrinDRUG -
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Signed Informed Consent that meets all criteria of current FDA regulations. 2. Male or non-pregnant, non-lactating female at least 2 years of age or older. 3. Diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestat...

Countries:United StatesEl SalvadorPanama
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