NCT05929794

Pharmacokinetics of Transdermal Metronidazole

Impact of Formulation on the Pharmacokinetics of Micropatch-assisted Delivery of Metronidazole

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metronidazole 0.75% Topical Gel	Half of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole gel and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or gel). At 48 hours occlusive coverings and gel are removed and electrical resistance measurements are repeated. Fresh gel and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites.
DRUG	Metronidazole 0.75% Topical Cream	Half of enrolled subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm. Color will only be measured at baseline. Micropatch application will occur at 2 sites, followed by application of metronidazole cream and then covered with an occlusive covering. One site will be covered with an occlusive covering only (no micropatch or cream). At 48 hours occlusive coverings and cream are removed and electrical resistance measurements are repeated. Fresh cream and occlusive patches are reapplied. At 96 hours the patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis. After a minimum 7 days washout period, all of these procedures will be repeated again except that there will be no micropatch application at any of the 3 sites.
DIAGNOSTIC_TEST	Transdermal water loss measurement	Baseline measurements of transepidermal water loss will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied).
DIAGNOSTIC_TEST	Electrical Resistance	Baseline measurements of electrical resistance will be made at 3 sites on the upper arm. In the study periods that have micropatch application, the measurements will be repeated after micropatch application and removal (before any metronidazole product is applied). In all study periods the measurements will also be repeated at 48 hours and 96 hours, when metronidazole product and occlusive coverings are removed from the skin.
DIAGNOSTIC_TEST	Skin color measurement	Baseline measurements of skin color will be made at 3 sites on the upper arm.
OTHER	Micropatch application	All subjects will undergo this intervention. Baseline measurements of transepidermal water loss, electrical resistance, and color will be made at 3 sites on the upper arm (color only measured at baseline). Two sites will have micropatch application + metronidazole product with occlusive covering. One site will have micropatch application + occlusive covering, no metronidazole product. Micropatch application will only occur on day 1 (a micropatch is a patch of 50 microneedles). Transepidermal water loss and electrical resistance are repeated after micropatch application and removal. At 48 hours occlusive coverings and metronidazole are removed; electrical resistance measurements are repeated. Metronidazole product and fresh occlusive patches are reapplied. At 96 hours patches are removed and electrical resistance measurements repeated. Blood samples are taken daily for 5 days. Measurements from the 3rd site allow each subject to serve as their own control in data analysis.

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-07-03
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study