COMPLETED

Metronidazole SC Penetrance With Moisturizers

Conditions

Rosacea, Erythematotelangiectatic rosacea metronidazole LC-MS tape strip

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-03

Study Completion:2025-11-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06434519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Matthew M Draelos, MD PhD

PRINCIPAL_INVESTIGATOR

Duke University

John Murray, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Matthew M Draelos, MD PhD, PRINCIPAL_INVESTIGATOR, Duke University
John Murray, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2025-11-04

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2025-11-04

Terms related to this study

Keywords Provided by Researchers

rosacea
metronidazole
LC-MS
tape strip

Additional Relevant MeSH Terms

Rosacea, Erythematotelangiectatic