Drug updated on 9/4/2024
Dosage Form | Suspension (topical; 0.9%) |
Drug Class | Antiparasitic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the topical treatment of head lice infestations in adult and pediattic patients 6 months of age and older.
- For the topical treatment of scabies infestations in adult and pediatric 4 years of age older.
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Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Natroba (spinosad) Prescribing Information. | 2021 | ParaPRO LLC, Carmel, IN |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Spinosad at 0.9% in the treatment of scabies: Efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies. | 206Subjects F: 57% M: 43% | 2022 | Journal of the American Academy of Dermatology |
Sex Distribution:
F:57%
M:43%
206Subjects
Year:
2022
Source:Journal of the American Academy of Dermatology