Metronidazole SC Penetrance With Moisturizers

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.

Conditions

• Rosacea, Erythematotelangiectatic

Interventions

DRUG

Metronidazole cream

After application of one of the moisturizers under investigation in this study to the right side of the patient's face, x5 tape strips will be collected from the left side of a patient's face. These will provide negative controls for quantitation of metronidazole in the stratum corneum. Then, 0.5 mL of a 1% metronidazole cream will be applied to both the right and left sides of a patient's face with clean gloves to prevent cross contamination. Tapes strips x5 will subsequently be collected from the left and right sides of the face at 1 hour and 4 hour time points to assess penetrance of metronidazole through the stratum corneum.

OTHER

Cetaphil moisturizer

0.5 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.

OTHER

CeraVe moisturizer

0.5 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.

OTHER

Eucerin Healing Lotion moisturizer

0.5 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.

OTHER

Aveeno Calm and Restore Oat Gel moisturizer

0.5 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.

Sponsors & Collaborators

• National Rosacea Society

  collaborator UNKNOWN

• Duke University

  lead OTHER

Principal Investigators

• Matthew M Draelos, MD PhD · Duke University

• John Murray, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-03

Primary Completion

2025-11-04

Completion

2025-11-04

Countries

• United States

Study Locations