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
NCT ID: NCT02094716
Last Updated: 2023-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2014-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Permethrin Foam 4%/ Permethrin Foam 4%
First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.
Permethrin Foam 4%
Topical application, whole-body treatment
Permethrin Foam 5%/ Permethrin Foam 5%
First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.
Permethrin Foam 5%
Topical application, whole-body treatment
Vehicle Foam / Permethrin Foam 4%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.
Permethrin Foam 4%
Topical application, whole-body treatment
Vehicle Foam
Topical application, whole-body treatment
Vehicle / Permethrin Foam 5%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Permethrin Foam 5%
Topical application, whole-body treatment
Vehicle Foam
Topical application, whole-body treatment
Interventions
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Permethrin Foam 4%
Topical application, whole-body treatment
Permethrin Foam 5%
Topical application, whole-body treatment
Vehicle Foam
Topical application, whole-body treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is in good general health with normal appearing skin in noninfested areas.
* Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.
Exclusion Criteria
* Subject has used any ectoparasiticide within the three weeks prior to study start.
* Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.
* Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.
* Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.
* Subject whose close personal contacts will not comply with standard of care for fomite management.
6 Months
ALL
No
Sponsors
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DPT Laboratories, Ltd.
INDUSTRY
Vyne Therapeutics Inc.
INDUSTRY
Mylan Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Fremont, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
Philadelphia, Pennsylvania, United States
Clinical Research Site
San Cristóbal, , Dominican Republic
Clinical Research Site
Santo Domingo, , Dominican Republic
Clinical Research Site
San Pedro Sula, , Honduras
Clinical Research Site
Ponce, , Puerto Rico
Countries
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Other Identifiers
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185-7851-201
Identifier Type: -
Identifier Source: org_study_id
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