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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: Recruiting Phase 4 study of Scabies, sponsored by Cipher Pharmaceuticals.
NCT05310734 is a Phase 4 study of Scabies that is actively recruiting participants, run by Cipher Pharmaceuticals. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05310734 shows while recruiting
NCT05310734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05310734's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
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