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PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
NCT05310734 · View on ClinicalTrials.gov ↗
Study Summary
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Conditions Studied
Interventions
- DRUG Spinosad Topical
Study Locations (3)
Florida
- L&C Professional Medical Research Institute — Miami
Louisiana
- Velocity Clinical Research — Lafayette
Texas
- Elixir Research Group — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05310734
The ClinicalTrials.gov registry entry for NCT05310734 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cipher Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Scabies appearing as the primary indexed condition, and to 1 intervention — of which Spinosad Topical is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05310734 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Louisiana, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05310734 about?
NCT05310734 is a clinical study titled "PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies". A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 sub...
What is the current status of trial NCT05310734?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2022-03-04. Estimated completion is 2026-03-31.
What conditions does trial NCT05310734 study?
This clinical trial studies the following conditions: Scabies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05310734?
The interventions under investigation include: Spinosad Topical (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05310734?
This trial is sponsored by Cipher Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05310734 being conducted?
This trial has 3 study locations across Florida, Louisiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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