drugset / Trial / NCT02485717

Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies

NCT02485717

Phase 3 Completed 291 enrolled ParaPRO LLC Concentrics Research · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the clinical cure of scabies after a single treatment. The trial will also assess the pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in pediatric subjects 4-16 years of age. These subjects will be a separate population of pediatric subjects.

Timeline

Start
2017-05-02
Primary completion
2018-06-25
Completion
2018-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Spinosad Small molecule 0.9 % Topical
Subject Spinosad Small molecule 120 ml Topical

Indications