A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, … (NCT02094716) | Clinical Trial Compass
CompletedPhase 2
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
United States130 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range6 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of active scabies infection.
* 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 is pregnant, lactating, or is planning to become pregnant during the study.
* 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.
What they're measuring
1
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"