A Multicenter, Randomized, Double-Blind, Parallel Group Comparison Study of the Safety and Efficacy of Permethrin Foam, 5% Versus Permethrin Foam, 4% Versus Vehicle in Subjects With Sarcoptes Scabiei
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mylan Inc.
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Permethrin Foam 4%/ Permethrin Foam 4%
First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.
Intervention: Permethrin Foam 4% (Drug)
Permethrin Foam 5%/ Permethrin Foam 5%
First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.
Intervention: Permethrin Foam 5% (Drug)
Vehicle Foam / Permethrin Foam 4%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.
Intervention: Permethrin Foam 4% (Drug)
Vehicle Foam / Permethrin Foam 4%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.
Intervention: Vehicle Foam (Drug)
Vehicle / Permethrin Foam 5%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Intervention: Permethrin Foam 5% (Drug)
Vehicle / Permethrin Foam 5%
First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Intervention: Vehicle Foam (Drug)
Outcomes
Primary Outcomes
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
Time Frame: Day 28
The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
Secondary Outcomes
- Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28(Baseline, Day 14, 28, and 42)
- Number of Re-treated Subjects Designated as "Treatment Success"(Day 42)
- Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose(Day 28 and Day 42)