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Tiny patches could boost skin drug delivery

NCT ID NCT05929794

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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