Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-06 @ 8:37 AM
Study NCT ID:
NCT00988533
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Sponsor:
Topaz Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: