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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Rosacea, Erythematotelangiectatic

Intervention / Treatment
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* Drug: Trametinib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient will receive two creams labeled right cheek or left cheek, one containing the active ingredient and the other serving as vehicle control. The labels of each bottle were randomized and the contents of each remains blinded to both the subject and the investigator.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trametinib<br>Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib) | Drug: Trametinib<br>* Topical cream containing 0.1 mg/g trametinib<br>* Other names: MAPK inhibitor;|
| Placebo Comparator: Vehicle<br>Cheek receiving cream without active compound (topical cream lacking active ingredient) | Drug: Trametinib<br>* Topical cream containing 0.1 mg/g trametinib<br>* Other names: MAPK inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dermatologic score | 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. | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic drug absorption | Blood levels of trametinib will be assessed by high-performance liquid chromatography | 22 days |