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NCT05310734 · ClinicalTrials.gov registry record · Phase 4
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
A Phase 4 study of Scabies, sponsored by Cipher Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT05310734 is a Phase 4 study of Scabies that is actively recruiting participants, run by Cipher Pharmaceuticals. The registered enrollment target is 50 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT05310734, a Phase 4 study of Scabies, is actively recruiting participants, sponsored by Cipher Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
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, categorized as Phase 4. 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 2 total studies on file at ClinicalTrials.gov.
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.
NCT05310734 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Louisiana, Texas.
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.
What interventions are being tested in trial NCT05310734?
The interventions under investigation include: Spinosad Topical (DRUG).
Who is sponsoring clinical trial NCT05310734?
This trial is sponsored by Cipher Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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