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

Mylan

Status and phase: Completed; Phase 2

Conditions: Scabies

Treatments: Drug: Vehicle Foam; Drug: Permethrin Foam 4%; Drug: Permethrin Foam 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094716

185-7851-201

Details and patient eligibility

About

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

Full description

It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.

Enrollment: 130 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 4 patient groups, including a placebo group

Permethrin Foam 4%/ Permethrin Foam 4%

Experimental group

Description:

First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.

Treatment:

Drug: Permethrin Foam 4%

Permethrin Foam 5%/ Permethrin Foam 5%

Experimental group

Description:

First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.

Treatment:

Drug: Permethrin Foam 5%

Vehicle Foam / Permethrin Foam 4%

Placebo Comparator group

Description:

First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.

Treatment:

Drug: Permethrin Foam 4%

Drug: Vehicle Foam

Vehicle / Permethrin Foam 5%

Placebo Comparator group

Description:

First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.

Treatment:

Drug: Permethrin Foam 5%

Drug: Vehicle Foam