Status:
RECRUITING
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
Lead Sponsor:
Cipher Pharmaceuticals Inc.
Collaborating Sponsors:
Concentrics Research
Iqvia Pty Ltd
Conditions:
Scabies
Eligibility:
All Genders
1-4 years
Phase:
PHASE4
Brief 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 sin...
Detailed Description
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 sin...
Eligibility Criteria
Inclusion
- Male or female, ages 1 month to 3 years and 11 months.
- 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.
- Generally, in good health based on medical history and clinical assessments.
- Normal-appearing skin in non-infested areas.
- No history of chronic or recurrent dermatologic disease.
- Willingness to comply with the study procedures including blood collections and application of study treatment in-clinic.
Exclusion
- Presence of crusted scabies (Norwegian scabies).
- Allergies or intolerance to ingredients in the Investigational Product.
- Known renal or hepatic impairment.
- Treatment with scabicide within the prior 2 weeks.
- Immunodeficiency (including HIV infection) as reported in Medical History.
- Signs or symptoms of systemic infection.
- Administration of systemic therapy for infectious disease within the prior 2 weeks.
- Receipt of any investigational product within the prior 4 weeks.
- Medications used for itching or other indication that contain benzyl alcohol or other alcohols within the past 7 days.
- Over-the-counter cortisone products within the past 7 days.
- Oral prescription medications and/or antibiotics within the past 7 days.
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05310734
Start Date
March 4 2022
End Date
March 31 2026
Last Update
February 14 2025
Active Locations (3)
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1
L&C Professional Medical Research Institute
Miami, Florida, United States, 33144
2
Velocity Clinical Research
Lafayette, Louisiana, United States, 70508
3
Elixir Research Group
Houston, Texas, United States, 77077