Conditions: Scabies
Keywords: Sarcoptes Scabiei Scabies ectoparasite parasite infestation Renaissance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

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.

Arms:
arm 1: First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. arm 2: First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. arm 3: First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. arm 4: First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary.

Interventions: intervention 1: Permethrin Foam 4% intervention 2: Permethrin Foam 5% intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Topical application, whole-body treatment intervention 2: Topical application, whole-body treatment intervention 3: Topical application, whole-body treatment

Protocol document: