Clinical trial

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

NCT02094716

Name

185-7851-201

Description

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

Trial arms

Trial start

2014-04-01

Estimated PCD

2014-12-01

Trial end

2014-12-01

Status

Completed

Phase

Early phase I

Treatment

Permethrin Foam 4%

Topical application, whole-body treatment

Arms:

Permethrin Foam 4%/ Permethrin Foam 4%, Vehicle Foam / Permethrin Foam 4%

Other names:

PF-045

Permethrin Foam 5%

Topical application, whole-body treatment

Arms:

Permethrin Foam 5%/ Permethrin Foam 5%, Vehicle / Permethrin Foam 5%

Other names:

PF-055

Vehicle Foam

Topical application, whole-body treatment

Arms:

Vehicle / Permethrin Foam 5%, Vehicle Foam / Permethrin Foam 4%

Other names:

Vehicle

Size

130

Primary endpoint

Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"

Day 28

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ACTUAL'}}

Updated at

2023-04-26

1 organization

2 products

1 indication

Organization

Product

Indication

Product