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Completed

NCT Number: NCT05616923

Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea

This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea

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Key information

Conditions

Rosacea, Erythematotelangiectatic Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samuel S. Stratton VA Medical Center

Albany, New York, 12208, United States

About this study

The duration of the study will be 22 days. Subjects will use a cream with a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor on one cheek, and a cream lacking the inhibitor (vehicle control) on the other. Patients will receive a randomized set of creams for the right and left cheek, one containing the active ingredient. Subjects will be evaluated on days 1, 8, 15 and 22. Skin appearance will be scored in each visit. A blood sample will be obtained to determine the levels of systemic drug absorption.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.

Exclusion criteria

  • Other concurrent diseases for which treatment is being received that would preclude the use of trametinib (i.e., pleural effusion, active infection, intracranial bleeding)
  • History of skin allergic reactions or documented allergic reaction to trametinib
  • Pregnancy or lactation.
  • Heart failure or other heart disease
  • Active use of medications with known documented interactions with trametinib (Chloroquine, Ritonavir, Loperamide, Penicillamine)

Treatment and study plan

Trametinib

Drug

Topical cream containing 0.1 mg/g trametinib

Other names: MAPK inhibitor

Primary outcomes

  1. Change in dermatologic score

    Time frame: 22 days

    Weekly assessment of skin irritation, using the Organization for Economic Cooperation and Development test for dermal irritation and corrosion. This test measures cutaneous erythema and edema separately on scales that range from 0 (absence of erythema or edema) to 4 (severe), with higher scores representing worse outcomes.

Secondary outcomes

  1. Systemic drug absorption

    Time frame: 22 days

    Blood levels of trametinib will be assessed by high-performance liquid chromatography

Sponsors and collaborators

Lead sponsor

Albany Research Institute, Inc.

Other

Registry information

Acronym: TOMIR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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