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

Pro00114776

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.

2024-08-01

2025-12-01

2025-12-01

Not yet recruiting

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "5 patients will enrolled in 4 study arms. Each study arm will represent a different combination of moisturizer applied to the face, followed by metronidazole cream. No moisturizer will be applied to the left side of each patient's face, permitting for each patient to represent their own negative (no metronidzole cream applied) and positive control (metronidazole cream + no moisturizer). Metronidazole penetrance in the stratum corneum will be assess with tape strips and LC-MS", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-05-30