Assessing the safety and pharmacokinetics of Natroba for treating scabies in young children

A Single 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

This study is testing if a new cream called Natroba is safe and effective for treating scabies in young children aged 1 month to nearly 4 years.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 1 Month to 4 Years
• Sex: All
• Sponsor: Cipher Pharmaceuticals Inc. (Industry-sponsored)
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT05310734 on ClinicalTrials.gov

What this trial studies

This clinical trial involves approximately 50 pediatric subjects aged 1 month to 3 years 11 months who have an active scabies infestation. Participants will receive a full-body application of Natroba topical suspension, and their blood will be sampled to evaluate the pharmacokinetics of spinosad and benzyl alcohol over a 3-hour period. The study will monitor safety through adverse event reporting and skin irritation assessments. The treatment will be applied in a clinical setting, and subjects will be observed for a short duration post-application.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to 3 years 11 months with a confirmed active scabies infestation.

Not a fit: Patients with crusted scabies or those with known allergies to the treatment ingredients may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective treatment option for young children suffering from scabies.

How similar studies have performed: Other studies have shown success with similar topical treatments for scabies, indicating a potential for positive outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female, ages 1 month to 3 years and 11 months.
2. Must have active scabies infestation confirmed by clinical signs and symptoms (evidence of burrows or presence of scabies inflammatory/non-inflammatory lesions and pruritus) as well as by burrow ink test (BIT) to demonstrate the presence of burrowing mites.
3. Generally, in good health based on medical history and clinical assessments.
4. Normal-appearing skin in non-infested areas.
5. No history of chronic or recurrent dermatologic disease.
6. Willingness to comply with the study procedures including blood collections and application of study treatment in-clinic.

Exclusion Criteria:

1. Presence of crusted scabies (Norwegian scabies).
2. Allergies or intolerance to ingredients in the Investigational Product.
3. Known renal or hepatic impairment.
4. Treatment with scabicide within the prior 2 weeks.
5. Immunodeficiency (including HIV infection) as reported in Medical History.
6. Signs or symptoms of systemic infection.
7. Administration of systemic therapy for infectious disease within the prior 2 weeks.
8. Receipt of any investigational product within the prior 4 weeks.
9. Medications used for itching or other indication that contain benzyl alcohol or other alcohols within the past 7 days.
10. Over-the-counter cortisone products within the past 7 days.
11. Oral prescription medications and/or antibiotics within the past 7 days.
12. Any other conditions that, at the investigator's discretion, may interfere with the study conduct, or which might confound the interpretation of the study results, or which may put the subject at undue risk.

Where this trial is running

Miami, Florida and 2 other locations

• L&C Professional Medical Research Institute — Miami, Florida, United States (Recruiting)
• Velocity Clinical Research — Lafayette, Louisiana, United States (Recruiting)
• Elixir Research Group — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: William Miller, MD — Concentrics Research
• Study coordinator: Sharda Angl

Conditions Scabies; Pharmacokinetics; PK; Pharmacokinetics and Safety Study of Spinosad; PK and Safety Study of Spinosad; Spinosad PK and Safety Study; Safety; Pharmacokinetic and Safety Study of Natroba