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

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

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

Study Overview

• Status: Completed
• Conditions: Scabies
• Intervention / Treatment: Drug: Permethrin Foam 4%; Drug: Permethrin Foam 5%; Drug: Vehicle Foam

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • San Cristóbal, Dominican Republic
    • Clinical Research Site
  • Santo Domingo, Dominican Republic
    • Clinical Research Site
• Honduras
  • San Pedro Sula, Honduras
    • Clinical Research Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Clinical Research Site
• United States
  • California
    • Fremont, California, United States, 94538
      • Clinical Research Site
    • Los Angeles, California, United States, 90036
      • Clinical Research Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Clinical Research Site
  • New York
    • New York, New York, United States, 10018
      • Clinical Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Vyne Therapeutics Inc.; DPT Laboratories, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: parasite; Scabies; Sarcoptes; Scabiei; ectoparasite; infestation; Renaissance
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Permethrin
• Other Study ID Numbers: 185-7851-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No