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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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 Investigational Product (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 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. 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 Natroba 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 4
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
L&C Professional Medical Research Institute
RECRUITING
Miami
Louisiana
Velocity Clinical Research
RECRUITING
Lafayette
Texas
Elixir Research Group
RECRUITING
Houston
Contact Information
Primary
Sharda Angl
sangl@cipherpharma.com
905-602-5840
Backup
Nina Garrett
nina.garrett@concentricsresearch.com
800-800-5525
Time Frame
Start Date: 2022-03-04
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 50
Treatments
Experimental: PK and Safety
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.
Related Therapeutic Areas
Sponsors
Collaborators: Iqvia Pty Ltd, Concentrics Research, Inotiv Laboratories, BioAgilytix, Medpace, Inc.
Leads: Cipher Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov