Assessing how moisturizers affect metronidazole absorption in rosacea treatment
Evaluation of the Effect of Moisturizers on the Absorption of Metronidazole Into the Stratum Corneum of Rosacea Patients With Tape Stripping and Liquid Chromatography-mass Spectrometry
This study is testing how using different moisturizers before applying metronidazole can affect how well the medication works for people with rosacea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06434519 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of applying moisturizers before topical metronidazole on the drug's ability to penetrate the skin in patients with erythematotelangiectatic rosacea. Participants will receive a combination of metronidazole and one of four different moisturizers during a single office visit. Skin samples will be collected using tape strips at one and four hours post-application and analyzed using liquid chromatography mass spectrometry (LC-MS) to measure the penetrance of metronidazole. The goal is to provide scientific evidence regarding the common practice of using moisturizers alongside topical treatments for rosacea.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-pregnant individuals aged 18-60 with a diagnosis of rosacea.
Not a fit: Patients with known allergies to the study products or those with significant skin damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize treatment strategies for rosacea patients, potentially improving their skin health and quality of life.
How similar studies have performed: While there has been limited research on the effect of moisturizers on drug penetrance, one previous study has assessed a similar approach with azelaic acid, indicating that this area is under-explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy, non-pregnant individual 18+ years of age; 2. Subjects willing to allow a series of tape pieces to be pressed and removed from their faces over an 4 hour period; 3. Subjects can remain calm and quiet at the research facility for 6 hours; 4. Subjects in general good health as determined from a medical history; 5. Subjects must read and sign the informed consent form after the nature of the study has been fully explained. Exclusion Criteria: 1. Subjects with known allergies or sensitivities to ingredients contained in the test products; 2. Subjects with an allergy to latex or adhesives; 3. Subjects with excessive visible sun damage on the face, such that the dermatologist investigator considers the subject unsuitable for study entry; 4. Subjects with skin growths or other issues on the face that could interfere with the tape sampling; 5. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.); 6. Subjects viewed by the investigator as not being able to complete the study; 7. Subjects unwilling to refrain from using any type of lotion, medication, or other topical product to the face for a set amount of time prior to the study.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Matthew M Draelos, MD PhD — Duke University
- Study coordinator: Matthew M Draelos, MD PhD
- Email: matthew.draelos@duke.edu
- Phone: (919) 684-3432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.