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

Albany Research Institute, Inc.12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rosacea, Erythematotelangiectatic

Interventions

TrametinibDRUG

Topical cream containing 0.1 mg/g trametinib

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Samuel S. Stratton VA Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 22 days

Secondary Outcomes

Systemic drug absorption

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

Time frame: 22 days

Data from ClinicalTrials.gov

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