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Permethrin

Phase 3

Scabies | Small molecule | Infectious Disease |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

Permethrin · 1 trial · 1 indication

Phase 3 1
NCT02572986A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of ScabiesScabies
COMPLETED250 Analytics
PHASE3COMPLETED
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
ScabiesUnlock trial analytics

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 to 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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Frequently asked questions about Permethrin

What is Permethrin used for?

Permethrin is a small molecule drug being developed for the treatment of scabies, a skin infestation caused by mites. It is currently in Phase 3 clinical development as a topical cream formulation.

Who makes Permethrin?

Permethrin is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY.

What phase is Permethrin in?

Permethrin is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Permethrin in?

Permethrin has one completed Phase 3 clinical trial, identified as NCT02572986. This study evaluated the therapeutic equivalence of generic Permethrin Cream 5% to Elimite in the treatment of scabies, enrolling 250 participants in the United States, El Salvador, and Panama.

Is Permethrin the same as Elimite?

Permethrin is being studied as a generic version of Elimite. The clinical trial NCT02572986 was designed to evaluate whether generic Permethrin Cream 5% is therapeutically equivalent to Elimite in treating scabies.