Summary

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• Natroba (spinosad) is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older, and for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older.
• This summary is based on the review of one randomized controlled trial. ^[1]
• Primary Efficacy Outcome: Spinosad 0.9% demonstrated a significantly higher complete cure rate for scabies on day 28, with 78.1% of index subjects achieving a complete cure compared to 39.6% in the vehicle group (P < 0.0001; n = 206).
• Additional Efficacy Measures: Other outcomes, including clinical cure, microscopic cure, and lesion counts, consistently favored spinosad 0.9%, showing robust effectiveness across multiple efficacy metrics.
• Population Considerations: The studies were conducted on subjects aged 4 years and older, with no reported differences in effectiveness based on age, gender, or comorbid conditions within this population.
• Safety Profile: No significant safety concerns or adverse effects were reported in the studies evaluating spinosad 0.9% for the treatment of scabies. No safety signals were observed across the study population, which included subjects aged 4 years and older.
• Subgroup Findings: The study on spinosad 0.9% for scabies treatment included subjects aged 4 years and older, focusing on the youngest household members with active scabies. Spinosad 0.9% demonstrated significantly higher effectiveness compared to the vehicle in achieving a complete cure by day 28 (78.1% vs. 39.6%, P < 0.0001), with no differentiation in outcomes based on specific subgroups such as age, gender, or comorbid conditions.