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

NCT02485717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2021-05-19

Study results available
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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.

Conditions

  • Scabies

Interventions

DRUG

spinosad topical suspension, 0.9%

Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.

OTHER

Placebo

Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.

Sponsors & Collaborators

  • Concentrics Research

    collaborator OTHER

  • ParaPRO LLC

    lead INDUSTRY

Principal Investigators

  • Kerry W Mettert, MBA · ParaPRO LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2018-06-25
Completion
2018-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485717 on ClinicalTrials.gov