A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous
and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.
I. Explore the adverse event profile of a menadione topical lotion to the face to prevent
rash from EGFR inhibitors.
II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.
ARM II: Patients apply topical placebo lotion BID for 28 days.
After completion of study treatment, patients are followed up for 4 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cutaneous discomfort as measured by the face pain scale question. Descriptive statistics and longitudinal plots will be used for summarizing cutaneous discomfort.
Weekly during the 4-week treatment period
Aminah Jatoi, M.D.
United States: Food and Drug Administration
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