Arm A (Menadione)

Arm B (Placebo)

Total

Sex: Female, Male

Region of Enrollment

Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.

Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort

The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.

The Number of Patients Experiencing Worst Toxicity

Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.

Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)

Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.

Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)

Overall Study

Aminah Jatoi, M.D.

Dermatologic Complications

Malignant Neoplasm

Pain

menadione topical lotion

placebo

questionnaire administration

management of therapy complications

Mayo Clinic Campus in Arizona

Mayo Clinic

Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

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

Subjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment.

Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy

EGFR Inhibitor-associated Rash

Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.

Menadione Topical Lotion

Menadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy.

Solano Clinical Research

Robert H. Lurie Cancer Center, Northwestern University

Massachusetts General Hospital

Washington University School of Medicine

Fox Chase Cancer Center

The University of Texas, MD Anderson Cancer Center

McGill University

Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash

A Phase 1, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability, and Systemic Absorption of Menadione Topical Lotion as an Emergent and Pre-emergent Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash

menadione/سرطان

Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash

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