Tiny patches could boost skin drug delivery
NCT ID NCT05929794
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study in 24 healthy adults tests whether using a micropatch before applying metronidazole gel or cream improves how much drug gets into the bloodstream. Participants receive both formulations at different times, and researchers measure drug levels and skin changes. The goal is to see if micropatches can enhance topical drug delivery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metronidazole 0.75% topical gel and cream
- What this could lead to
- If successful, this could show that micropatches improve how well topical drugs absorb through skin, potentially leading to more effective treatments for skin infections.
- What could go wrong
- This is a small, early-phase study in healthy people, not patients. It only measures drug levels in blood, not actual treatment effectiveness. Results may not apply to diseased skin.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or non-pregnant women ≥18 years old, of any ethnic background * Provide written informed consent before initiation of any study procedures * Available for follow-up for the planned duration of the study * Able to communicate well with the investigators * Able to adhere to the study protocol schedule, study restrictions and examination schedule * Subjects deemed to be healthy, as determined by the study physician, based on medical history, current medical conditions, and medication history * Agrees not to participate in another clinical study during the study period unless the study is in the follow up phase and it has been 1 month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 1 month after last procedure day * Agrees not to donate blood to a blood bank throughout participation in the study and for at least 2 months after last procedure day. Exclusion Criteria: * Unable to give consent * Inability to communicate or cooperate with the investigators * Known previous adverse reaction to microneedle insertion * Known allergy or adverse reaction to medical tape/adhesive, or aloe vera * Women who are pregnant or lactating * Abnormal vital signs or lab values deemed to be medically significant by the study physician or Principal Investigator * Positive urine drug screening test * Known prior serious adverse reaction or hypersensitivity to metronidazole or any metronidazole products * History of anaphylaxis to an antibiotic, antimicrobial, antifungal, antipartisitic, or antiviral drug * Current smoker or regular use of nicotine or tobacco products * Participation in any ongoing investigational drug trial or clinical drug trial unless the study is in the follow up phase and it has been ≥1 month since the subject received any experimental agents or treatments * Current use of medications in the following therapeutic classes: HMGCoA reductase inhibitors ("statins"), beta-blockers, oral or topical steroids, oral antibiotics, topical antibiotics at the local treatment site, topical antihistamines at the local treatment site, and oral or topical NSAIDs/analgesics. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or NSAIDs/analgesics may be enrolled if more than 5 elimination half-lives of the drug have passed since the last dose. The estimated elimination half-life for any specific drug will be obtained from standard pharmacy references such as Micromedex or other comparable references. * Current or recent use of any prescription medication that, in the opinion of the study physician or Principal Investigator, would present a safety risk when used concomitantly with metronidazole * Any current medical conditions (acute or chronic) that may pose a risk for study participation, as determined by the study physician or Principal Investigator * Any condition that would, in the opinion of the study physician or Principal Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol * Uncontrolled mental illness that would, in the opinion of the study physician or Principal Investigator, affect the subject's ability to understand or reliably participate in the study * Subject has presence of a skin condition, excessive hair at the application site, sunburn, raised moles and scars, open sores at application site, scar tissue, tattoo, coloration, or any other local condition that would interfere with placement of patches, microneedles, study drug, skin assessment, or reactions to drug * Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria). * Any current malignancy or history of malignancy at the treatment site * Prior history of keloids or excessive scarring * Prior history of skin pigmentation changes or significant dermal reaction to a topically applied drug product
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Iowa
Iowa City, Iowa, 52242, United States
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