A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

Inclusion Criteria

• •Subjects and/or parent/guardian must have understood and signed appropriately administered informed consent/assent in their own language
• •Healthy male and non-pregnant/non-lactating female subjects aged 2 months to 65 years diagnosed with scabies
• •Must have dermatological evidence of active scabies (burrows, erythematous papules, etc.) confirmed by recovery of live Sarcoptes scabiei (the Principal investigator or trained and experienced Study Team examines the specimen(s) under magnification to verify the identity and viability of the scabies mite, ova, or mite feces at the site)
• •The youngest subject (with scabies infestation as defined above) from each household is considered the index or primary subject of the household for evaluation of the primary endpoint. Other members of the household and close contacts are enrolled in the study as Secondary subjects and evaluated for all safety parameters (not included in primary endpoint analysis). Secondary subjects that are confirmed to have dermatological evidence of scabies should receive the same study treatment as the Index subject
• •Must be available and willing to report for follow up visits
• •Is otherwise healthy, well-nourished, non-febrile and not suffering from an infection likely to require systemic antibiotic or topical therapy. These criteria will be ascertained during screening by the Principal investigator
• •Must agree not to use other scabicides or other medications likely to affect the evaluation of their response to scabies treatment
• •If female of childbearing potential, willing to use an acceptable method of birth control, should be stable for 3 months prior to screening and throughout the study
• •Must be willing to follow the procedures to decrease infestation: Clothes and bed linens that were in contact with the subjects, their household members and close contacts during the previous 48 to 72 hours will be machine washed at 60°C and machine dried the day after the first treatment. For materials that cannot be laundered, insecticide powder or aerosolized insecticide may be used, or the items may be kept in a sealed bag for at least 48 to 72 hours.