Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
- Registration Number
- NCT05616923
- Lead Sponsor
- Albany Research Institute, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trametinib Trametinib Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib) Vehicle Trametinib Cheek receiving cream without active compound (topical cream lacking active ingredient)
- Primary Outcome Measures
Name Time Method Change in dermatologic score 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 Outcome Measures
Name Time Method Systemic drug absorption 22 days Blood levels of trametinib will be assessed by high-performance liquid chromatography
Trial Locations
- Locations (1)
Samuel S. Stratton VA Medical Center
🇺🇸Albany, New York, United States