Transdermal Metronidazole Absorption in Healthy Volunteers

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Iowa

Must not be taking: Statins, Beta-blockers, Steroids, others

Disqualifiers: Pregnancy, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are currently using medications like statins, beta-blockers, steroids, antibiotics, antihistamines, and NSAIDs. If you've recently used these, you can join if enough time has passed since your last dose.

Is transdermal metronidazole safe for humans?

Metronidazole 1% gel has been shown to be mild to the skin, with low potential for causing irritation or allergic reactions, and no evidence of causing reactions when exposed to light. ^{1 2 3 4 5}

How does the drug Metronidazole 0.75% Topical Cream and Gel differ from other treatments?

The Metronidazole 0.75% Topical Cream and Gel are unique because they offer better skin penetration compared to higher concentration formulations, suggesting that the delivery method (cream or gel) is more important than the concentration for effective absorption. This makes them potentially more effective for conditions like rosacea, where reaching the deeper skin layers is crucial. ^{1 2 3 6 7}

What data supports the effectiveness of the drug Metronidazole 0.75% Topical Cream and Gel?

Research shows that Metronidazole 0.75% cream and gel penetrate the skin more effectively than other formulations, suggesting that the way the drug is delivered (the vehicle) is crucial for its effectiveness. This means that the cream and gel forms are likely to be more effective in delivering the drug to the skin where it is needed. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Healthy adults over 18, of any ethnic background, who are not pregnant or lactating and do not smoke or use nicotine products. Participants must have no significant skin conditions, allergies to antibiotics, or history of adverse reactions to metronidazole. They should not be on certain medications like steroids or beta-blockers and must agree to avoid other clinical studies during the trial.

Inclusion Criteria

Subjects deemed to be healthy, as determined by the study physician, based on medical history, current medical conditions, and medication history

Provide written informed consent before initiation of any study procedures

Available for follow-up for the planned duration of the study

Exclusion Criteria

History of anaphylaxis to an antibiotic, antimicrobial, antifungal, antipartisitic, or antiviral drug

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

I have or had cancer at the site where I am seeking treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive metronidazole product applied to micropatch-treated skin, with daily blood samples collected for up to 5 days

5 days

Daily visits for blood sampling

Washout

One-week washout period between treatment periods

1 week

Treatment Period 2

Participants receive metronidazole product applied to skin without micropatch pretreatment, with daily blood samples collected for up to 5 days

5 days

Daily visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metronidazole 0.75% Topical Cream
• Metronidazole 0.75% Topical Gel
• Micropatch application

Trial Overview The study is testing how well a gel and cream form of Metronidazole (an antibiotic) pass through the skin after micropatch treatment. It's a crossover study where participants will try both forms in different periods to compare their effectiveness.

How Is the Trial Designed?

Group I: Micropatch application + metronidazole 0.75% topical cream Active Control 5 Interventions

Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical cream

Group II: Metronidazole 0.75% topical gel Active Control 4 Interventions

Participants will have metronidazole 0.75% topical gel applied without the pre-treatment micropatch application

Group III: Micropatch application + metronidazole 0.75% topical gel Active Control 5 Interventions

Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical gel

Group IV: Metronidazole 0.75% topical cream Active Control 4 Interventions

Participants will have metronidazole 0.75% topical cream applied without the pre-treatment micropatch application

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

The new 1.0% metronidazole gel formulation for treating rosacea is effective in reducing inflammatory lesions and erythema, and it is designed to be more user-friendly and cosmetically appealing than the previous 0.75% gel.

Safety evaluations showed that the 1% gel has low irritation potential, minimal risk of sensitization, and no evidence of phototoxic or photoallergic reactions, making it a safe option for patients with rosacea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A look at the safety of metronidazole 1% gel: cumulative irritation, contact sensitization, phototoxicity, and photoallergy potential. Beutner, KR., Lemke, S., Calvarese, B.[2013]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Differential penetration of skin by topical metronidazole formulations. [2014]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Topical bio(in)equivalence of metronidazole formulations in vivo. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

Metronidazole concentration in the bloodstream following its topical application, at different concentration levels, on experimental skin wounds during healing by secondary intention1. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Percutaneous absorption kinetics of topical metronidazole formulations in vitro in the human cadaver skin model. [2019]

6. England pubmed.ncbi.nlm.nih.gov

In vitro and in vivo evaluation of three metronidazole topical products. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A look at the safety of metronidazole 1% gel: cumulative irritation, contact sensitization, phototoxicity, and photoallergy potential. [2013]