NCT05616923

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Albany Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Rosacea, Erythematotelangiectatic

Interventions

Type	Name	Description
DRUG	Trametinib	Topical cream containing 0.1 mg/g trametinib

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-11-15
• Last updated: 2023-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study