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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

Primary Purpose

Scabies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Permethrin Foam 4%
Permethrin Foam 5%
Vehicle Foam
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scabies focused on measuring Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site
  • Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Permethrin Foam 4%/ Permethrin Foam 4%

Permethrin Foam 5%/ Permethrin Foam 5%

Vehicle Foam / Permethrin Foam 4%

Vehicle / Permethrin Foam 5%

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 20, 2014
Last Updated
April 24, 2023
Sponsor
Mylan Inc.
Collaborators
DPT Laboratories, Ltd., Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02094716
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
DPT Laboratories, Ltd., Vyne Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies
Keywords
Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permethrin Foam 4%/ Permethrin Foam 4%
Arm Type
Experimental
Arm Description
First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary.
Arm Title
Permethrin Foam 5%/ Permethrin Foam 5%
Arm Type
Experimental
Arm Description
First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary.
Arm Title
Vehicle Foam / Permethrin Foam 4%
Arm Type
Placebo Comparator
Arm Description
First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary.
Arm Title
Vehicle / Permethrin Foam 5%
Arm Type
Placebo Comparator
Arm Description
First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.
Intervention Type
Drug
Intervention Name(s)
Permethrin Foam 4%
Other Intervention Name(s)
PF-045
Intervention Description
Topical application, whole-body treatment
Intervention Type
Drug
Intervention Name(s)
Permethrin Foam 5%
Other Intervention Name(s)
PF-055
Intervention Description
Topical application, whole-body treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle Foam
Other Intervention Name(s)
Vehicle
Intervention Description
Topical application, whole-body treatment
Primary Outcome Measure Information:
Title
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Day 14, 28, and 42
Title
Number of Re-treated Subjects Designated as "Treatment Success"
Description
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.
Time Frame
Day 42
Title
Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose
Description
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.
Time Frame
Day 28 and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Research Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Clinical Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Clinical Research Site
City
San Cristóbal
Country
Dominican Republic
Facility Name
Clinical Research Site
City
Santo Domingo
Country
Dominican Republic
Facility Name
Clinical Research Site
City
San Pedro Sula
Country
Honduras
Facility Name
Clinical Research Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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