NCT02094716

A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies

A Multicenter, Randomized, Double-Blind, Parallel Group Comparison Study of the Safety and Efficacy of Permethrin Foam, 5% Versus Permethrin Foam, 4% Versus Vehicle in Subjects With Sarcoptes Scabiei

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.

Detailed description

It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Permethrin Foam 4%	Topical application, whole-body treatment
DRUG	Permethrin Foam 5%	Topical application, whole-body treatment
DRUG	Vehicle Foam	Topical application, whole-body treatment

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-03-24
• Last updated: 2023-04-26
• Results posted: 2021-01-15

Locations

9 sites across 4 countries: United States, Dominican Republic, Honduras, Puerto Rico

Regulatory

• FDA-regulated drug study