Transdermal Metronidazole Absorption in Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how metronidazole, a medication for skin conditions, absorbs through the skin when applied as a cream or gel. Researchers use a special micropatch to assess whether it enhances medication delivery. The trial compares four methods: cream with micropatch, cream without, gel with micropatch, and gel without. Healthy individuals without a history of adverse reactions to skin treatments may qualify for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
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.
What is the safety track record for these treatments?
Research has shown that metronidazole, in both cream and gel forms, is generally safe for topical use. Studies have found that these forms do not absorb into the body through the skin, reducing the risk of systemic side effects. Common side effects include mild skin irritation, such as redness or dryness, and occasionally a metallic taste in the mouth. These effects are typically short-lived.
For the cream and gel used with a micropatch, similar minor side effects have been observed. Some cases of allergic reactions and skin rashes have occurred with topical use, but these are uncommon.
Overall, both the cream and gel forms of metronidazole are considered safe for most people when used as directed. These findings can reassure prospective trial participants about the safety of the treatments being tested.12345Why are researchers enthusiastic about this study treatment?
Unlike the typical treatments for skin conditions like rosacea, which usually involve oral antibiotics or standard topical applications, these investigational treatments use a unique transdermal delivery method with a micropatch. This method could potentially enhance the absorption of metronidazole, a common antibiotic, making it more effective. Researchers are excited because this could lead to faster, more efficient treatment with potentially fewer side effects, as the medication is delivered directly to the affected area, minimizing systemic exposure.
What evidence suggests that this trial's treatments could be effective for transdermal metronidazole absorption?
Research has shown that metronidazole 0.75% cream and gel effectively treat skin conditions like rosacea. One study found that 77% of patients using metronidazole gel remained symptom-free for six months, compared to 58% using a placebo. Both the cream and gel versions penetrate the skin better than other forms, enhancing the delivery of the active ingredient. In this trial, some participants will receive metronidazole 0.75% cream or gel with a micropatch application, which may further improve absorption, while others will receive the cream or gel without the micropatch. Overall, metronidazole 0.75% in both forms has proven effective for skin issues.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive metronidazole product applied to micropatch-treated skin, with daily blood samples collected for up to 5 days
Washout
One-week washout period between treatment periods
Treatment Period 2
Participants receive metronidazole product applied to skin without micropatch pretreatment, with daily blood samples collected for up to 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Metronidazole 0.75% Topical Cream
- Metronidazole 0.75% Topical Gel
- Micropatch application
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Iowa
Lead Sponsor