Clinical Trials Directory

Trials / Completed

CompletedNCT02572986

A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies

A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% to Elimite™ Cream 5% in the Treatment of Scabies

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Dr. Reddy's Laboratories Limited · Industry
Sex
All
Age
2 Years
Healthy volunteers
Not accepted

Summary

Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older. This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.

Conditions

Interventions

TypeNameDescription
DRUGPermethrin

Timeline

Start date
2015-09-01
Primary completion
2016-06-01
Completion
2016-08-01
First posted
2015-10-09
Last updated
2016-10-14

Locations

13 sites across 3 countries: United States, El Salvador, Panama

Source: ClinicalTrials.gov record NCT02572986. Inclusion in this directory is not an endorsement.