Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05929794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-14
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Transdermal Metronidazole
Sponsor:
University of Iowa
Organization:
Study Overview
Official Title:
Impact of Formulation on the Pharmacokinetics of Micropatch-assisted Delivery of Metronidazole
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
This is a crossover pharmacokinetic clinical study in healthy volunteers to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch.
Detailed Description:
The goal of this crossover pharmacokinetic clinical study in healthy volunteers is to compare metronidazole delivery through skin when a gel or cream metronidazole product is applied to skin treated with a micropatch. The main questions this study aims to answer are:
* Is micropatch transdermal delivery dependent on the metronidazole product formulation?
* Is transdermal delivery dependent on micropore lifetime of the skin after micropatch application?
Participants will be divided into groups based on metronidazole product (gel or cream).
* The metronidazole product will be applied to micropatch-treated skin in study period one. Measurements of the skin barrier will be made before and after micropatch treatment.
* Daily blood samples will be collected for up to 5 days after the micropatch and metronidazole are first applied.
* Following a one-week washout period, the same study process will be repeated except that metronidazole product will be applied to skin without micropatch pretreatment.
* Is micropatch transdermal delivery dependent on the metronidazole product formulation?
* Is transdermal delivery dependent on micropore lifetime of the skin after micropatch application?
Participants will be divided into groups based on metronidazole product (gel or cream).
* The metronidazole product will be applied to micropatch-treated skin in study period one. Measurements of the skin barrier will be made before and after micropatch treatment.
* Daily blood samples will be collected for up to 5 days after the micropatch and metronidazole are first applied.
* Following a one-week washout period, the same study process will be repeated except that metronidazole product will be applied to skin without micropatch pretreatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: