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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Sc

Brief 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.

Detailed Summary:
Sponsor: Dr. Reddy's Laboratories Limited

Current Primary Outcome: Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies [ Time Frame: Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The proportion of patients with no itch persistence [ Time Frame: Day 28 ]

Original Secondary Outcome: Same as current

Information By: Dr. Reddy's Laboratories Limited

Dates:
Date Received: October 8, 2015
Date Started: September 2015
Date Completion:
Last Updated: October 13, 2016
Last Verified: October 2015