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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Scabies

Intervention / Treatment
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* Drug: Permethrin Foam 4%
* Drug: Permethrin Foam 5%
* Drug: Vehicle Foam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Permethrin Foam 4%/ Permethrin Foam 4%<br>First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. | Drug: Permethrin Foam 4%<br>* Topical application, whole-body treatment<br>* Other names: PF-045;|
| Experimental: Permethrin Foam 5%/ Permethrin Foam 5%<br>First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. | Drug: Permethrin Foam 5%<br>* Topical application, whole-body treatment<br>* Other names: PF-055;|
| Placebo Comparator: Vehicle Foam / Permethrin Foam 4%<br>First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. | Drug: Permethrin Foam 4%<br>* Topical application, whole-body treatment<br>* Other names: PF-045;Drug: Vehicle Foam<br>* Topical application, whole-body treatment<br>* Other names: Vehicle;|
| Placebo Comparator: Vehicle / Permethrin Foam 5%<br>First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. | Drug: Permethrin Foam 5%<br>* Topical application, whole-body treatment<br>* Other names: PF-055;Drug: Vehicle Foam<br>* Topical application, whole-body treatment<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as Treatment Success | 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. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The change in the total score of signs and symptoms related to the condition in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28. Scale details: The overall average presence of the individual signs and symptoms of scabies was evaluated over the entire body. Erythema, papules, pustules, crusting, scaling, excoriations, and pruritus were assessed as follows for each sign and symptom: None=0, Trace=1, Mild=2, Moderate=3, Severe=4. From these assessments, the total score of the Signs and Symptoms (from 0 to 28, higher scores mean a worse outcome) was calculated as the sum of the individual signs and symptoms scores at Baseline and Days 2, 14, 28, and 42 (if applicable).The change from baseline in the total score can range from -28 as the best reduction possible (better outcome) to +28 as the worst increase possible (worse outcome) in signs and symptoms. | Baseline, Day 14, 28, and 42 | 
| Number of Re-treated Subjects Designated as Treatment Success | Each subject was designated as re-treatment success at Day 42 based upon the criteria in the protocol to which he/she was enrolled. 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. | Day 42 | 
| Number of Subjects Designated as Treatment Success Following One Treatment With an Active Dose | The proportion of subjects designated as treatment success following one treatment versus two treatments. 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. Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis. Subjects who did not improve at Day 14 were counted as failures at Day 28. Subjects who improved at Day 14 and received a second treatment in error were counted as failures at Day 28. | Day 28 and Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance