Metronidazole SC Penetrance With Moisturizers

Launched by DUKE UNIVERSITY · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a common treatment for rosacea called metronidazole works when used with moisturizers. Rosacea is a skin condition that causes redness and inflammation, and metronidazole is a cream that helps reduce these symptoms. Researchers want to find out if putting on moisturizer before applying metronidazole makes a difference in how much of the medication gets absorbed into the skin. Participants in this study will have one visit where they will receive a combination of metronidazole and one of four different moisturizers applied to their face. They will then undergo a gentle process of tape stripping to collect small samples of skin at different times for testing.

To participate, individuals need to be healthy adults aged 18 to 60 who are not pregnant and can stay calm during the study visit, which lasts about six hours. They should not have any known allergies to the products used in the study or any significant skin issues that could interfere with the results. The study is considered safe, as all products involved are already approved for use and the tape stripping method is non-invasive, meaning it won’t cause bleeding or long-term skin damage, although some temporary bruising may occur. Overall, this study will help improve our understanding of how these treatments work together for people with rosacea.

Gender

ALL

Eligibility 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.

Trial Officials