NCT03178942

Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies

A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% (Encube Ethicals) Compared to Elimite™ Cream (Permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Encube Ethicals Pvt. Ltd. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.

Detailed description

A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5% (Encube Ethicals) Compared to Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies. The objectives of this study are to: 1. Evaluate the therapeutic equivalence of the Test formulation, Permethrin Cream, 5% (Encube Ethicals) to the marketed product, Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in patients with scabies. 2. Compare the safety of Test and Reference treatments in patients with scabies.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Permethrin Cream, 5%	Permethrin Cream 5%
DRUG	Elimite™ Cream (permethrin) 5%	Permethrin Cream 5%

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-11-11
• Completion: 2017-11-11
• First posted: 2017-06-07
• Last updated: 2019-03-26
• Results posted: 2019-03-14

Locations

15 sites across 3 countries: United States, El Salvador, Puerto Rico

Regulatory

• FDA-regulated drug study