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

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 12 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 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 12-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5, 1.0, 3.0, 6.0- and 12-hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. Removal of IP must occur after the 6-hour blood draw and at least 1 hour before 12-hour blood draw. A ±5-minute time window will be allowed for all post-treatment blood samples. 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 NatrobaTM 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ParaPRO LLC
• Collaborators: Concentrics Research; Inotiv Laboratories; Medpace, Inc.; MicroConstants, Inc.; STATKING Clinical Services

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 microscopic examination of skin scraping to demonstrate the presence of mites, eggs, and/or scybala.

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.