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Anti-infective agent
Transdermal Metronidazole Absorption in Healthy Volunteers
Phase 4
Recruiting
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Awards & highlights
Study Summary
This trial compares how well two metronidazole skin products are absorbed by the body.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include local skin irritation at the application site, allergic reactions if sensitive to Metronidazole or components in the gel/cream, and possible discomfort from microneedle insertion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 1, 1.5, 2, 4, 6, 8, 24, 48, 72, 96, 98, 100, 104, and 120 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the serum-concentration curve from 0-120 hours
Measurement of maximum serum metronidazole concentration (Cmax)
Time of maximum serum metronidazole concentration (Tmax)
Secondary outcome measures
Change in electrical resistance after micropatch application
Change in transepidermal water loss after micropatch application
Skin color
Trial Design
4Treatment groups
Active Control
Group I: Micropatch application + metronidazole 0.75% topical creamActive Control5 Interventions
Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical cream
Group II: Metronidazole 0.75% topical gelActive Control4 Interventions
Participants will have metronidazole 0.75% topical gel applied without the pre-treatment micropatch application
Group III: Micropatch application + metronidazole 0.75% topical gelActive Control5 Interventions
Participants will have pre-treatment micropatch application followed by metronidazole 0.75% topical gel
Group IV: Metronidazole 0.75% topical creamActive Control4 Interventions
Participants will have metronidazole 0.75% topical cream applied without the pre-treatment micropatch application
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
447 Previous Clinical Trials
879,698 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had cancer at the site where I am seeking treatment.I am 18 years or older and not pregnant.I am not on any medication that is unsafe to use with metronidazole, according to my doctor.I have had skin color changes or strong reactions to skin-applied drugs before.I have a history of serious skin conditions or diseases that affect my skin's appearance or response.I am not currently using statins, beta-blockers, steroids, antibiotics, antihistamines, or NSAIDs.I agree not to donate blood during and for 2 months after the study.My skin is clear where the drug or device will be applied.I am unable to understand and give consent for treatment.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Micropatch application + metronidazole 0.75% topical cream
- Group 2: Metronidazole 0.75% topical gel
- Group 3: Micropatch application + metronidazole 0.75% topical gel
- Group 4: Metronidazole 0.75% topical cream
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial still open to participants?
"According to clinicaltrials.gov, this particular trial is not actively pursuing participants at the moment; it was initially posted on October 1st 2023 and last updated June 29th 2023. However, there are currently 780 other medical trials recruiting patients now."
Answered by AI
Has the Food and Drug Administration authorized Micropatch application in tandem with metronidazole 0.75% topical gel?
"Our team has awarded Micropatch application + metronidazole 0.75% topical gel a score of 3, as this treatment is already approved and currently undergoing Phase 4 trials."
Answered by AI
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