Clinical trial NCT02094716: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scabies
Keywords: Sarcoptes
Scabiei
Scabies
ectoparasite
parasite
infestation
Renaissance
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: DPT Laboratories, Ltd.
name: Vyne Therapeutics Inc.
First posted: 2014-03-24
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
timeFrame: Day 28
Secondary outcomes:
measure: 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
timeFrame: Baseline, Day 14, 28, and 42
measure: Number of Re-treated Subjects Designated as "Treatment Success"
timeFrame: Day 42
measure: Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose
timeFrame: Day 28 and Day 42
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: New York
country: United States
facility: Clinical Research Site
state: New York
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: San Cristóbal
country: Dominican Republic
facility: Clinical Research Site
city: Santo Domingo
country: Dominican Republic
facility: Clinical Research Site
city: San Pedro Sula
country: Honduras
facility: Clinical Research Site
city: Ponce
country: Puerto Rico
facility: Clinical Research Site
Study officials:
References: