NCT06434519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
Last Updated

January 30, 2026

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

May 16, 2024

Last Update Submit

January 28, 2026

Conditions

Rosacea, Erythematotelangiectatic

Keywords

rosaceametronidazoleLC-MStape strip

Outcome Measures

Primary Outcomes (1)

  • Metronidazole penetrance through the stratum corneum (SC)

    Metronidazole stratum corneum penetrance will be ascertained with LC-MS (liquid chromatography-mass spectrometry). Tape strips (x5) will be collected at the 1 hour and 4 hour time points post application of metronidazole.

    1 hours and 4 hours post metronidazole application

Study Arms (4)

Metronidazole cream + Cetaphil moisturizer

EXPERIMENTAL

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.

Drug: Metronidazole creamOther: Cetaphil moisturizer

Metronidzole cream + CeraVe moisturizer

EXPERIMENTAL

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.

Drug: Metronidazole creamOther: CeraVe moisturizer

Metronidzole cream + Eucerin Healing Lotion moisturizer

EXPERIMENTAL

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.

Drug: Metronidazole creamOther: Eucerin Healing Lotion moisturizer

Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer

EXPERIMENTAL

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.

Drug: Metronidazole creamOther: Aveeno Calm and Restore Oat Gel moisturizer

Interventions

CeraVe moisturizerOTHER

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.

Metronidzole cream + CeraVe moisturizer
Eucerin Healing Lotion moisturizerOTHER

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.

Metronidzole cream + Eucerin Healing Lotion moisturizer
Aveeno Calm and Restore Oat Gel moisturizerOTHER

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.

Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer
Metronidazole creamDRUG

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.

Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizerMetronidazole cream + Cetaphil moisturizerMetronidzole cream + CeraVe moisturizerMetronidzole cream + Eucerin Healing Lotion moisturizer
Cetaphil moisturizerOTHER

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.

Metronidazole cream + Cetaphil moisturizer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, non-pregnant individual 18+ years of age;
  • Subjects willing to allow a series of tape pieces to be pressed and removed from their faces over an 4 hour period;
  • Subjects can remain calm and quiet at the research facility for 6 hours;
  • Subjects in general good health as determined from a medical history;
  • Subjects must read and sign the informed consent form after the nature of the study has been fully explained.

You may not qualify if:

  • Subjects with known allergies or sensitivities to ingredients contained in the test products;
  • Subjects with an allergy to latex or adhesives;
  • Subjects with excessive visible sun damage on the face, such that the dermatologist investigator considers the subject unsuitable for study entry;
  • Subjects with skin growths or other issues on the face that could interfere with the tape sampling;
  • Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.);
  • Subjects viewed by the investigator as not being able to complete the study;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (14)

  • Thiboutot D, Anderson R, Cook-Bolden F, Draelos Z, Gallo RL, Granstein RD, Kang S, Macsai M, Gold LS, Tan J. Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2020 Jun;82(6):1501-1510. doi: 10.1016/j.jaad.2020.01.077. Epub 2020 Feb 7.

    PMID: 32035944BACKGROUND

  • Gallo RL, Granstein RD, Kang S, Mannis M, Steinhoff M, Tan J, Thiboutot D. Rosacea comorbidities and future research: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2018 Jan;78(1):167-170. doi: 10.1016/j.jaad.2017.06.150. No abstract available.

    PMID: 29102687BACKGROUND

  • Del Rosso JQ, Lehman PA, Raney SG. Impact of order of application of moisturizers on percutaneous absorption kinetics: evaluation of sequential application of moisturizer lotions and azelaic acid gel 15% using a human skin model. Cutis. 2009 Mar;83(3):119-24.

    PMID: 19363903BACKGROUND

  • Draelos ZD, Draelos MM, Steele F, Georgiou M, Praestegaard M. Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology. Dermatol Ther (Heidelb). 2023 Aug;13(8):1763-1771. doi: 10.1007/s13555-023-00959-3. Epub 2023 Jun 23.

    PMID: 37351830BACKGROUND

  • Draelos ZD, Draelos MM. Development of a Tape-Stripping Liquid Chromatography-Mass Spectrometry Method for Evaluating Skin Deposition of Topical Tazarotene. J Drugs Dermatol. 2021 Oct 1;20(10):1105-1111. doi: 10.36849/JDD.6211.

    PMID: 34636513BACKGROUND

  • Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018 Aug;179(2):282-289. doi: 10.1111/bjd.16481. Epub 2018 May 31.

    PMID: 29478264BACKGROUND

  • Turpeinen M. Absorption of hydrocortisone from the skin reservoir in atopic dermatitis. Br J Dermatol. 1991 Apr;124(4):358-60. doi: 10.1111/j.1365-2133.1991.tb00597.x.

    PMID: 2025556BACKGROUND

  • Danby SG, Draelos ZD, Gold LFS, Cha A, Vlahos B, Aikman L, Sanders P, Wu-Linhares D, Cork MJ. Vehicles for atopic dermatitis therapies: more than just a placebo. J Dermatolog Treat. 2022 Mar;33(2):685-698. doi: 10.1080/09546634.2020.1789050. Epub 2020 Jul 16.

    PMID: 32654550BACKGROUND

  • Ghadially R, Halkier-Sorensen L, Elias PM. Effects of petrolatum on stratum corneum structure and function. J Am Acad Dermatol. 1992 Mar;26(3 Pt 2):387-96. doi: 10.1016/0190-9622(92)70060-s.

    PMID: 1564142BACKGROUND

  • Brand RM, Charron AR, Sandler VL, Jendrzejewski JL. Moisturizing lotions can increase transdermal absorption of the herbicide 2,4-dichlorophenoxacetic acid across hairless mouse skin. Cutan Ocul Toxicol. 2007;26(1):15-23. doi: 10.1080/15569520601182791.

    PMID: 17464745BACKGROUND

  • Huh Y, Lee DH, Choi D, Lim KM. Effect of Cosmetics Use on the In Vitro Skin Absorption of a Biocide, 1,2-Benzisothiazolin-3-one. Toxics. 2022 Feb 24;10(3):108. doi: 10.3390/toxics10030108.

    PMID: 35324733BACKGROUND

  • Feldmann RJ, Maibach HI. Regional variation in percutaneous penetration of 14C cortisol in man. J Invest Dermatol. 1967 Feb;48(2):181-3. doi: 10.1038/jid.1967.29. No abstract available.

    PMID: 6020682BACKGROUND

  • Tipthara P, Kobylinski KC, Godejohann M, Hanboonkunupakarn B, Roth A, Adams JH, White NJ, Jittamala P, Day NPJ, Tarning J. Identification of the metabolites of ivermectin in humans. Pharmacol Res Perspect. 2021 Feb;9(1):e00712. doi: 10.1002/prp2.712.

    PMID: 33497030BACKGROUND

  • Vanol PG, Sanyal M, Shah PA, Shrivastav PS. Quantification of metronidazole in human plasma using a highly sensitive and rugged LC-MS/MS method for a bioequivalence study. Biomed Chromatogr. 2018 Aug;32(8):e4242. doi: 10.1002/bmc.4242. Epub 2018 Apr 22.

    PMID: 29572903BACKGROUND

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Matthew M Draelos, MD PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • John Murray, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 30, 2024

Study Start

September 3, 2024

Primary Completion

November 4, 2025

Study Completion

November 4, 2025

Last Updated

January 30, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)