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

Scabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094716
• Other study ID #: 185-7851-201
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Permethrin Foam 4%
Topical application, whole-body treatment
• Permethrin Foam 5%
Topical application, whole-body treatment
• Vehicle Foam
Topical application, whole-body treatment

Locations

Country	Name	City	State
Dominican Republic	Clinical Research Site	San Cristóbal
Dominican Republic	Clinical Research Site	Santo Domingo
Honduras	Clinical Research Site	San Pedro Sula
Puerto Rico	Clinical Research Site	Ponce
United States	Clinical Research Site	Fremont	California
United States	Clinical Research Site	Hialeah	Florida
United States	Clinical Research Site	Los Angeles	California
United States	Clinical Research Site	New York	New York
United States	Clinical Research Site	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Mylan Inc.	DPT Laboratories, Ltd., Vyne Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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