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

Completed · Phase 2

Conditions studied: Scabies

In brief

To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.

Key facts

Study ID

NCT02094716

Run by

Mylan Inc.

People needed

130

Starts

2014-04-01

Expected to finish

2014-12-01

Last updated by the study team

2023-04-26

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 Cristobal, Dominican Republic
• Clinical Research Site — Santo Domingo, Dominican Republic
• Clinical Research Site — San Pedro Sula, Honduras
• Clinical Research Site — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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