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NCT06434519 · ClinicalTrials.gov registry record · NA
Metronidazole SC Penetrance With Moisturizers
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT06434519: Completed NA study, sponsored by Duke University.
NCT06434519 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06434519, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
Topical metronidazole is a widely used first line treatment for erythemotelangiectatic and inflammatory rosacea. Commonly, a moisturizer is also used to restore the skin barrier and reduce inflammation. The purpose of this study is to assess the whether the common practice of applying moisturizer prior to topical metronidazole affects this medication's stratum corneum penetrance in rosacea patients. Participants will have one research office visit that will consist of having a randomly assigned combination of metronidazole and one of four moisturizers applied to their face, followed by non-invasive tape stripping of skin at the 1 hour and 4 hour time points. These tape strip samples will be analyzed with liquid chromatography mass spectrometry (LC-MS) for assessment of metronidazole penetrance in the stratum corneum in the presence of moisturizers. The target population will be rosacea patients in the age range of 18-60 years of age. This study has minimal risks/safety issues as topical metronidazole is an already FDA approved medication with an indication for rosacea and all investigated moisturizers are over-the-counter formulations commonly used within the rosacea patient population. Tape stripping will remove 5 levels of superficial stratum corneum, and will not result in bleeding, scarring, or other prolonged cosmetic disfigurement. Small, transient bruising may result from tape strip collection. The collected samples will have no to minimal biohazard risk, as the collected specimen for analysis will only contain skin scale; samples will be extracted with organic solvents and decontaminated with a 0.2 micron nylon filter prior to analysis on the LC-MS instrumentation.
Primary Outcome
Metronidazole stratum corneum penetrance will be ascertained with LC-MS (liquid chromatography-mass spectrometry). Tape strips (x5) will be collected at the 1 hour and 4 hour time points post application of metronidazole.
Interventions
- DRUG Metronidazole cream
- OTHER CeraVe moisturizer
- OTHER Cetaphil moisturizer
- OTHER Eucerin Healing Lotion moisturizer
- OTHER Aveeno Calm and Restore Oat Gel moisturizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2025-11-04 |
| Phase | NA |
What the finished NCT06434519 record still lists
NCT06434519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Metronidazole cream is the first listed.
NCT06434519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06434519 about?
NCT06434519 is a clinical study titled "Metronidazole SC Penetrance With Moisturizers". Topical metronidazole is a widely used first line treatment for erythemotelangiectatic and inflammatory rosacea. Commonly, a moisturizer is also used to restore the skin barrier and reduce inflammation. The purpose of this study is to assess the whether the common practice of applying moisturizer pr...
What is the current status of trial NCT06434519?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2024-09-03. Estimated completion is 2025-11-04.
What interventions are being tested in trial NCT06434519?
The interventions under investigation include: Metronidazole cream (DRUG), CeraVe moisturizer (OTHER), Cetaphil moisturizer (OTHER), Eucerin Healing Lotion moisturizer (OTHER), Aveeno Calm and Restore Oat Gel moisturizer (OTHER).
Who is sponsoring clinical trial NCT06434519?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06434519's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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