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

Albany Research Institute, Inc.

Status and phase

Completed

Phase 1

Conditions

Rosacea, Erythematotelangiectatic

Treatments

Drug: Trametinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05616923

137506

Details and patient eligibility

About

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

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)