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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

NCT02094716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-04-26

Study results available
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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.

Conditions

  • Scabies

Interventions

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

Sponsors & Collaborators

  • DPT Laboratories, Ltd.

    collaborator INDUSTRY

  • Vyne Therapeutics Inc.

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-12-31
Completion
2014-12-31
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic
  • Honduras
  • Puerto Rico

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 NCT02094716 on ClinicalTrials.gov