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Natroba Topical Suspension for Scabies

Phase 4
Recruiting
Led By William Miller, MD
Research Sponsored by ParaPRO LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have active scabies infestation confirmed by clinical signs and symptoms as well as by burrow ink test (BIT) to demonstrate the presence of burrowing mites
Normal-appearing skin in non-infested areas.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
Awards & highlights

Study Summary

This trial will assess the PK of spinosad and benzyl alcohol for 12 hours following a single, full-body topical application of Natroba on a single in-clinic visit.

Who is the study for?
This trial is for children aged 1 month to under 4 years with active scabies, confirmed by clinical signs and microscopic examination. They should be in good health overall, have normal skin in non-infested areas, no chronic skin diseases, and willing to undergo study procedures like blood collections. Children who've used certain medications or treatments recently or have systemic infections or immunodeficiency are excluded.Check my eligibility
What is being tested?
The trial tests Natroba Topical Suspension on young children with scabies. It involves a single full-body application of the medication at a clinic visit, followed by monitoring for three hours and blood samples taken before treatment and after half an hour and three hours post-treatment.See study design
What are the potential side effects?
Possible side effects include general skin irritation or eye irritation from the topical suspension. Adverse events will be monitored throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have scabies confirmed by symptoms and a positive burrow ink test.
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My skin looks normal in areas not affected by the condition.
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I am between 1 month and 3 years old.
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I have no history of ongoing skin conditions.
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I have been diagnosed with scabies confirmed by skin symptoms and lab tests.
Select...
I am between 1 month and 3 years old.
Select...
I have no history of ongoing skin conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples collected up to 3 hours post treatment - 0 (pre-treatment), 0.5 and 3.0 hours post-treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) 0-3 for Benzyl Alcohol
Area Under the Curve (AUC) 0-3 for Spinosyn A
Area Under the Curve (AUC) 0-3 for Spinosyn D
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PK and SafetyExperimental Treatment1 Intervention
A Single 6-hour Treatment, Pharmacokinetic and Safety Study of Natroba (spinosad) Topical Suspension 0.9% w/w in Subjects 1 Month to 3 Years 11 Months of Age with an Active Scabies Infestation.

Find a Location

Who is running the clinical trial?

STATKING Clinical ServicesUNKNOWN
1 Previous Clinical Trials
10 Total Patients Enrolled
MicroConstants, Inc.UNKNOWN
ParaPRO LLCLead Sponsor
11 Previous Clinical Trials
1,923 Total Patients Enrolled
2 Trials studying Scabies
571 Patients Enrolled for Scabies

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prerequisites for participating in this medical experiment?

"This medical research is searching for 50 infants and toddlers (1 month to 4 years old) with a confirmed scabies infestation. To qualify, patients must be of either gender and generally in good health as determined by an assessment. Moreover, the subject's skin should appear normal besides the site of infection; no chronic or recurrent dermatologic issues are allowed either. Lastly, participants have to agree to comply with all study protocols including blood draws and topical application at the clinic."

Answered by AI

Can individuals of 18 years or older partake in this clinical investigation?

"This trial aims to recruit patients aged between 1 Month and 4 years old, with 5 studies for minors and an additional 2 studies aimed at individuals over 65."

Answered by AI

How many areas are hosting this investigation?

"This trial is currently running across a total of 4 sites, including Anaheim, Philadelphia and Sugarloaf. It's advised to choose the one closest to you so that travel can be minimized if necessary."

Answered by AI

Are any openings available in this clinical experiment for participants?

"Data hosted on clinicaltrials.gov points to this research trial actively recruiting participants; the initial posting date was April 3rd 2022 with the most recent update occurring March 25th of this year."

Answered by AI

How many participants have signed up for this experiment?

"To commence the trial, ParaPRO LLC must secure 50 suitable participants. Omnibus Clinical Research in Anaheim and Paddington Testing Company in Philadelphia are two of the sites involved with this endeavour."

Answered by AI

Has the FDA sanctioned Spinosad Topical as a legitimate treatment?

"The safety of Spinosad Topical has been rated a 3 due to being in the approved Phase 4 trial, indicating that it is safe for public use."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Omnibus Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Omnibus Clinical Research: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
2022. "PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05310734.
All > Scabies
~22 spots leftby Nov 2025
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