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

NCT02094716 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 185-7851-201
• Study Type: interventional
• Target: 130
• Locations: 4 countries
• Sites: 9

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.

Conditions

Scabies

Keywords

Sarcoptes; Scabiei; Scabies; ectoparasite; parasite; infestation; Renaissance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

Permethrin Foam 4%/ Permethrin Foam 4%

EXPERIMENTAL

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

Drug: Permethrin Foam 4%

Permethrin Foam 5%/ Permethrin Foam 5%

EXPERIMENTAL

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

Drug: Permethrin Foam 5%

Vehicle Foam / Permethrin Foam 4%

PLACEBO COMPARATOR

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

Drug: Permethrin Foam 4%; Drug: Vehicle Foam

Vehicle / Permethrin Foam 5%

PLACEBO COMPARATOR

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

Drug: Permethrin Foam 5%; Drug: Vehicle Foam

Interventions

Permethrin Foam 4% DRUG

Topical application, whole-body treatment

Also known as: PF-045

Permethrin Foam 4%/ Permethrin Foam 4%; Vehicle Foam / Permethrin Foam 4%

Permethrin Foam 5% DRUG

Topical application, whole-body treatment

Also known as: PF-055

Permethrin Foam 5%/ Permethrin Foam 5%; Vehicle / Permethrin Foam 5%

Vehicle Foam DRUG

Topical application, whole-body treatment

Also known as: Vehicle

Vehicle / Permethrin Foam 5%; Vehicle Foam / Permethrin Foam 4%

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• DPT Laboratories, Ltd.: collaborator
• Vyne Therapeutics Inc.: collaborator

Study Sites (9)

Clinical Research Site

Fremont, California, 94538, United States

Location

Clinical Research Site

Los Angeles, California, 90036, United States

Location

Clinical Research Site

Hialeah, Florida, 33016, United States

Location

Clinical Research Site

New York, New York, 10018, United States

Location

Clinical Research Site

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Research Site

San Cristóbal, Dominican Republic

Location

Clinical Research Site

Santo Domingo, Dominican Republic

Location

Clinical Research Site

San Pedro Sula, Honduras

Location

Clinical Research Site

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Scabies; Parasitic Diseases

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Sciences Program Lead
• Organization: Mylan Pharmaceuticals Pvt Ltd

prasannac.ganapathi@mylan.in

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 26, 2023
• Results First Posted: January 15, 2021

Record last verified: 2023-04

Locations

DO (2); PR (1); HO (1); US (5)