Drug updated on 4/10/2024
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.
Summary
- Spinosad (Natroba) is indicated for the topical treatment of head lice and scabies infestations in adults and pediatric patients, with age restrictions varying between 6 months to 4 years depending on the condition.
- The study was derived from a randomized controlled trial.
- In terms of efficacy, Spinosad showed significant results compared to placebo. Approximately 78.1% of the subjects treated with Spinosad achieved complete cure by day 28 post-treatment as opposed to only 39.6% in the placebo group.
- Safety-wise, no adverse effects were reported among study participants, indicating that it is well-tolerated and safe for use in treating scabies infestations.
- Although direct comparisons with other treatments are not provided within this study, it suggests potential advantages over approved products due to its natural source, reducing chances of resistance development.
- The study tested Spinosad on both adult and pediatric patients aged four years or older, suggesting its applicability across various age groups; however, detailed subgroup analysis data isn't available, limiting insight into differential efficacy or safety profiles within subgroups.
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