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Anti-infective agent

Metronidazole and Moisturizers for Rosacea

N/A

Recruiting

Led By John Murray, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, non-pregnant individual 18+ years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hours and 4 hours post metronidazole application

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if applying moisturizer before using topical metronidazole affects how well the medication penetrates the skin in rosacea patients. Participants will be randomly assigned to receive a combination of

Who is the study for?

This trial is for rosacea patients aged 18-60. Participants must be willing to have a combination of metronidazole and one of four moisturizers applied to their face, followed by non-invasive skin sampling at specific times during a single office visit.

What is being tested?

The study tests if applying moisturizer before the topical rosacea medication metronidazole affects how well it penetrates the top layer of skin. It involves randomly pairing metronidazole with one of four different moisturizers and measuring drug levels in the skin after application.

What are the potential side effects?

Since both metronidazole and the moisturizers are commonly used and FDA-approved, risks are minimal. The main side effect may be small, temporary bruises from where the tape strips collect skin samples.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18, not pregnant, and healthy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hours and 4 hours post metronidazole application

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hours and 4 hours post metronidazole application

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hours and 4 hours post metronidazole application for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metronidazole penetrance through the stratum corneum (SC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Metronidzole cream + Eucerin Healing Lotion moisturizerExperimental Treatment2 Interventions

Apply Eucerin Healing Lotion (mineral oil (occlusive) and sorbitol/propylene glycol (humecants)) followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.

Group II: Metronidzole cream + CeraVe moisturizerExperimental Treatment2 Interventions

Apply CeraVe (glycerin/hyaluronic acid (humectant), ceramides (intercellular lipid component), and dimethicone/petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.

Group III: Metronidazole cream + Cetaphil moisturizerExperimental Treatment2 Interventions

Apply Cetaphil (glycerin (humectant) and petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.

Group IV: Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizerExperimental Treatment2 Interventions

Apply Aveeno Calm and Restore Oat Gel (glycerin (humectant) and dimethicone (occlusive) and oat kernel flour based gel moisturizer) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metronidazole cream

2015

Completed Phase 3

~410

0 / 1Eligibility criteria met