PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies

Launched by CIPHER PHARMACEUTICALS INC. · Mar 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Natroba for young children aged 1 month to just under 4 years who have scabies, which is a skin condition caused by tiny mites that create itchy rashes and bumps. The trial aims to understand how well the medication works and how safe it is for this age group. To participate, children must have a confirmed scabies infestation and be generally healthy. They should not have certain skin conditions or recent treatments that could affect the study.

During the trial, caregivers will apply Natroba to the child's entire body, and the child will stay at the clinic for a few hours for some blood tests to monitor how the body responds to the treatment. After a minimum of 6 hours, the caregiver can gently wash off the medication. Participants will receive additional scabies medications for family members when they leave the clinic. It’s important for families to know that if a child has crusted scabies or any allergies to the ingredients in the treatment, they won’t be eligible for this study. Overall, this trial is a step toward understanding better options for treating scabies in very young children.

Gender

ALL

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.